• Baxter VP on the Benefits of ISO Standards • Regulations for the Transport of Dangerous Goods © ISO Focus, Contents

ISO Focus The Magazine of the International Organization for Standardization Volume 6, No. 6, June 2009, ISSN 1729-8709

• Baxter VP on the benefits of ISO standards • Regulations for the transport of dangerous goods © ISO Focus, www.iso.org/isofocus Contents

1 Comment George Arnold, ISO Vice-President (policy) and Chair of ISO/IEC/ITU Strategic Advisory Group on Security 2 World Scene Highlights of events from around the world 3 ISO Scene Highlights of news and developments from ISO members 4 Guest View Cheryl L. White, Corporate Vice President, Quality at Baxter ISO Focus is published 11 times a year (single issue : July-August). 7 Main Focus It is available in English. Annual subscription 158 Swiss Francs Individual copies 16 Swiss Francs Publisher Tackling hazards ISO Central Secretariat (International Organization for Standardization) 1, ch. de la Voie-Creuse CH-1211 Genève 20 Switzerland Telephone + 41 22 749 01 11 Fax + 41 22 733 34 30 E-mail [email protected] Web www.iso.org • Future ISO 31000 standard on risk management • Enhancing societal resilience Manager : Roger Frost • Ensuring safety and efficacy of medical devices Editor : Elizabeth Gasiorowski-Denis • Pandemic preparedness – New ISO report on use of fever Assistant Editor : Maria Lazarte screening equipment Artwork : Pascal Krieger and Pierre Granier • Condom testing contributes to disease prevention ISO Update : Dominique Chevaux • Fire safety saves lives Subscription enquiries : Sonia Rosas Friot • ISO standard for building escape and evacuation plans ISO Central Secretariat • Faster and safer interventions by emergency vehicles Telephone + 41 22 749 03 36 • Structural safety against natural hazards Fax + 41 22 749 09 47 • Earthquake design – Why do we still need experimental E-mail [email protected] confirmation ? © ISO, 2009. All rights reserved. • Rubber structural mounts save lives during earthquakes • Information security – Risks or hazards The contents of ISO Focus are copyright and may not, whether in whole or in part, be reproduced, stored in a retrieval system or transmitted in any form or 32 Developments and Initiatives by any means, electronic, mechanical, photocopying or otherwise, without Creating modern regulations for the transport of dangerous written permission of the Editor. goods • ISO President’s visits highlight “confidence” as key for The articles in ISO Focus express the views tackling global challenges of the author, and do not necessarily reflect the views of ISO or of any of its members. 35 New on the shelf ISSN 1729-8709 ISO for CEOs • ISO standard to ensure structures are not “gone Printed in Switzerland with the wind” • Lifting the safety level of cranes worldwide Cover photo : iStock. Montage ISO 37 Coming up ISO Focus June 2009 © ISO Focus, www.iso.org/isofocus Comment

Be prepared ! How International Standards help our world deal with hazards

azards are all around us. We sim- ing crisis, food safety, threats of con- security supply of telecommunications ply can’t escape them if we try – tamination) ; transportation (e.g. mari- and electricity. Hfrom a “ fender bender ” as we’re time port security, transport of dangerous ISO is also working on ensur- driving home, to cybersecurity attacks goods, RFID, freight container seals) ; ing there is a way to assess and manage on our business’s computer systems, to fires (e.g. equipment, protection); nat- the risks faced by business. This man- the hurricane expected to strike our area. ural disasters (e.g. earthquake resistant agement approach allows an objective The causes of hazards may be different – structures, wind actions) ; biometrics assessment of the likelihood and conse- whether human negligence, malevolence and personal identification (e.g. key quences of business risks and the poten- or natural disasters – but their likelihood in global efforts for combating terror- tial they have for business disruption. (and seriousness) is no less real. ism); and cybersecurity (e.g. preventing This is looking at hazards in a new and data theft). ISO also has in its portfo- Almost all hazards have a cost objective way. lio more generic, good practice stand- dimension, both human and economic. ards applicable to any sector or organ- One thing has become very clear. However, though calculating an exact ization, such as incident preparedness No one is immune from hazards, either figure is unrealistic, one can assume that and continuity management as well as intentionally or unintentionally provoked. the total cost to government, business and the future ISO 31000 standard on risk This has led to a global awareness that society is very high – and only getting management. organizations in the public and private higher. A number of hazards also have sectors must know how to prepare for global repercussions. Take, for exam- and respond to unexpected and poten- ple, the spread of the H1N1 influenza “ ISO is in an ideal tially devastating hazards. virus, causing fear of a pandemic across the globe. This is a stark reminder, not position to address Indeed, ISO is in an ideal posi- only of the global proportions that haz- hazards due to tion to address hazards due to the wide ards may reach, but also of the ensuing the wide spectrum of spectrum of fields it covers. But to do so implications to business continuity and it needs the concerted efforts of the glo- social life when danger strikes. fields it covers. ” bal community, from strong partnership between government and inter-govern- Response to such events before, mental organizations on one side, and when, and after they occur are matters Recognizing the global nature of security concerns, a Strategic Adviso- the private sector on the other. Let us of both hazards and disaster manage- do this together. ment practice and also of public policy ry Group on Security (SAG-S) consist- at national and international levels. In ing of members of the World Standards this context, ISO plays an important role Cooperation – ISO, the Electrotechnical by responding to market needs with glo- Commission (IEC) and the International bally relevant practical tools that assess, Telecommunication Union (ITU) – coor- prevent and combat hazards in the most dinates the efforts of the three organi- efficient manner. Standards help by : zations for a harmonized and strategic response to security needs. • Promulgating best practices and methodologies for addressing hazards From the reactivation of ISO technical committee ISO/TC 223 on societal • Specifying test methods and param- security to proposals on updating build- eters to aid in detection of threats ing infrastructure following the report • Specifying requirements to ensure and recommendations over the collapse that equipment and systems provide of the World Trade Centre, the SAG-S the necessary performance and pro- has approached security standards with George Arnold tection in extreme conditions. a high sense of urgency and speed-to- market. Today, the Strategic Group is ISO Vice President (policy) and Chair of ISO offers an extensive portfolio looking toward the future by exploring ISO/IEC/ITU Strategic Advisory Group of International Standards that address new initiatives such as secure “ Smart on Security hazards in such diverse areas as health Grid ” (new and efficient energy sup- and resources (e.g. drinking water dur- ply mechanisms) and ways to ensure

ISO Focus June 2009 1 © ISO Focus, www.iso.org/isofocus World Scene

Action urged to stop ISO Deputy Secretary-General road deaths Kevin McKinley represented ISO at the launch of the Make An international road safety Roads Safe report. decade for action, requesting governments to do more to Trade capacity building prevent road accidents world- for Eurasian economies For more information : wide, was called for in Rome, Joint effort for www.standards-education. Italy in May 2009 following Standards, metrology, testing standardization education and quality were the subjects org/workshops/ices-2009/ the launch of the second Organized by the Ministry of of a course on trade capacity presentations-2 Make Roads Safe report of Economy, Trade and Industry building held at the headquar- the Commission for Global of Japan, the International ters of the Institute of Stand- Oil and gas sector Road Safety. Cooperation for Education on ards and Industrial Research promotes use of ISO Standardization (ICES) held Developed for the Make Roads of Iran (ISIRI), ISO member its annual workshop in March standards Safe campaign (a broad-based for Iran, in Karaj, Iran, in April 2009, in Tokyo, Japan. The The International Associa- coalition of motoring and 2009 (photo below). Aimed at event was attended by 75 par- tion of Oil and Gas Producers health organi- the member states of the Eco- zations), the ticipants (photo above). (OGP) has published an issue nomic Cooperation Organization of its Standards Bulletin, pro- report says Japanese Industrial Standards (ECO), the course was a joint moting OGP’s collaboration that nearly Committee (JISC), ISO mem- project of ECO and the UN with ISO and encouraging the two million ber for Japan, Vice President Industrial Development sector to make use of the suite people die and former ISO President, Organization (UNIDO). of ISO standards for vital oil every year Masami Tanaka, underlined in on the Presenters from Russia and the and gas industry his keynote speech the increas- International Association of Oil & G Republic of Korea spoke on materials, equip- as Producers Sta ndard s Bull et in world’s ing importance of standardiza- executIve Summary A set of International S support these stan wide selection of tandards for a worldwide applicationdards for ment and off- materials, equipment vital an oil & gas industry American, Chinese, Europeans. North and South is emerging from th standards bodies are n d offshore structures and other harmonizing standards, the role Organization, I e International Standards for regional and national use ( ow adopting them roads. primarily the responSO. These standards are inside). For indu Global see details tion education, resulting from sibility of ISO Technical stry, they will reduce costs Committee 67 (ISO TC67) and delivery time, and f Standards developed using . They are across national borders. acilitateF trade a consensus process that includes more than 1400 oil & g they offer support for goal or regulators, Used Locally shore structures experts from around th functional regu as industry -setting and W of metrology, measurement and international review ande globeapproval and an higher levels of lations,safety througwhile achieving orldwide the large variety of profes- 138 ISO standards h process. These standards are now beinh better design. issued, including 18 revisionave now been implemented widel http://info.ogp.org.uk/standards/ g publications in 2008. A provinces arou y in oil and gas s or new nd the world, replacing Road acci- – currently 138 planned for public further 19 are existing industry, reg aggressively pursu international oil andation gas thisindu year. The standards and eliminional and national several API documentsing therelated publication to h of uncertainty, and quality man- issues in 2006 & 2007, and in national standardisation need for company-specificating or reducing the stry and urricane For details on stan of the progressive publ sional profiles involved in organisations specifications. consideration InternatIOnal ISO TC67, see thedards wal available from 19900 series docum ication of the ISO l-chart inside. leadership developedents, a strateg API SC 2 StanDarDS WOrkShOPS the content of its stan dents have y to restructure standards with OGP to the Australian and Mal closely with the ISO 19900dards to series. align Fmore agement systems. The training The OGP Standards Com & gas sector. To that end, presen the publication of the ISO stan aysian oil message promoting ‘g covered a range of topic many regions of the world are expec ollowing mittee has taken its tations dards, standardization, the new chal- locally worldwide’ the development and u s. Among them were adopt them as a basis f lobal standards used The 19-20 February to 2009 Australia event and in Malay standards, an overview seof of international design. Against this bacor offshore platformted to Developmen staged jointly with the Austral sia. the local Standards mapped out a plan kground, API has overtaken Perth was ways in whicht Organisations work, the an additional Production and Exploration to be implemented ian Petroleum Australian and Malaysian also provided an overview of (APPEA), the National Of standards fit into internation over the next few Association Ltd Safety Authority (NOPS fshore Petroleum Two principles stand ou al standards. years concerning lenges facing standardization Australia (SA). Th A) and Standards the need to acc the restructuring ISO TC67 t from both workshops: in Kuala Lumpur wase 23-24 arran February event IEC standards andelerate to h adoption of ISO sequence, alignment goes to Victoria, BC, Canada for its with PETRONAS Carigal ged jointly in the relevant ISO/IE eighten participation/ and adoption malaria as plenary meeting, 19 planned for Standards Malaysia and i,SI Department of Other topics on the agenC standards work. of the ISO 1-2 October 2009 ISO/IEC 17025, General RIM Berhard. ways in which intern da included the standards as API can help the local p ational standards standards. What was During his opening on a global scale and the overcoming the c etroleum industry, and once a Gulf of Mexico on address to the KL regulations with hallenges in aligning local has been expanded to oth workshop, Datuk ly focus ISO or IEC standards. waters and to co- er US coastal the leading cause of 2009. Abdullah Karim, global standards uoperative development for requirements for the compe- Vice-President, aPI OffShOre nder the ISO umbrella. PETRONAS stated: StructureS StanDarDS: “Technical standards increasing complexity of Datuk Abdullah Karim are crucial to chanGInG tImeS industries such as th preventable deaths in develop- They are now well imbeddedoil & gas industry. e API Subcommittee 2 on everything we do; from desig in almost provided the offshore oil structures has tence of testing and calibration their abandonment. These tec with useful standards f ning plants to and gas industry have helped us in design hnical standards for more than forty years.or offshoreIn structures standardization activities. reliable facilities. Th API started to map a long ter An OGP ing better and more the early 1990s, efficiency and eliminateey help wastefu to improve our its standards while actively m strategy for poor quality work. They h ing countries. In five years lness and the preparation of th participating in us to realise better returns fave helped most of of standards for of e ISO 19900 series laboratories, and its manage- and more importan or our stakeholders fshore structures. While our operations are saftly, they ensure that workshop an overstatemen e. Perhaps it is not depend on theset technicalto say that the industries time, traffic accidents will be An update on developments in sustain their profitability standards to The two workshop objec and growth.” ment and technical require- broadening the understandin tives included held in standardisation activities wh g of international the biggest single cause of ments. standardization education was ile introducing —2009: Standards B ulletin N Malaysia in o. 10— premature deaths for children given by representatives from continued… aged 5 to 14. The objectives were to identify the Americas, Asia and Europe. February 2009 also highlighted common standards for entering Panel discussions addressed the the utility of ISO standards for Five million deaths in the next into ECO Mutual Recognition promotion of standardization the industry. Datuk Abdullah ten years could be avoided if Agreements; to align project education, and cooperation for Karim, Vice-President of the governments act to introduce activities with the ECO Trade national and international activ- PETRONAS company, com- more effective policies. Agreement implementation proc- ities. mented : “ [ISO Standards] have helped most of us realize better The Make Roads Safe report ess; and to prepare the ground- Representatives of the World returns for our stakeholders includes a feature on the future work for the final phase of the Standards Cooperation (WSC) and, more importantly, ensure ISO road traffic safety man- ECO-UNIDO project. presented the vision of its that our operations are safe.” agement standard (ISO 39001) A series of activities were member organizations – ISO, saying “ this is a significant launched to strengthen the the International Electrotechni- The oil and gas sector has milestone in the history of standardization institutions of cal Commission (IEC), the recognized a market need for a traffic safety and will enable ECO member countries. International Telecommunica- global consensus process to thousands and potentially mil- tion Union (ITU-T) – on the develop uniform and consistent At the end of the course cer- lions of organizations to relation between standardiza- standards for worldwide appli- tificates were granted to 120 secure their own activities in tion and education, and briefed cation, and has renewed its participants from ISIRI and the road transport system .” participants on new initiatives commitment to working within other Iranian organizations. and cooperation in this field. the ISO system to develop a new suite of harmonized Inter- Among them the upcoming national Standards. “WSC Academia Week 2010”, which, designed to promote dia- Most of these standards are under logue between academic institu- the responsibility of technical tions and international standardi- committee ISO/TC 67, Materials, zation organizations, will take equipment and offshore struc- place in the third quarter of tures for petroleum, petrochemi- 2010. The 2010 ICES workshop cal and natural gas industries. will be hosted by ISO, IEC and Standards Bulletin issue : ITU in that framework. www.ogp.org.uk/pubs/4010.pdf © ISO Focus, www.iso.org/isofocus ISO Scene

Farewell to Derek The meeting examined Researchers and practitioners Spickernell a broad spectrum of with expertise in “ public warn- possibilities for stand- ing ” and familiarity with sirens, (1 June 1921 – 14 May 2009) ardization in the tour- alarms, signs and warning texts, ism sector – from yachting The objective of the seminar as well as other interested par- Derek Spickernell served as Tech- clubs to environmentally- (photo above) was to raise ties, are invited. nical Director and then as Direc- friendly accommodation, from awareness on the ISO standards The workshop is being hosted tor-General of BSI, until his cultural to industrial tourism. It and the GHG Protocol among by the Japanese Industrial retirement in June 1986. Mr. also looked at ISO/TC professionals working in stand- Standards Committee (JISC). Spickernell also served as ISO 228projects on diving, beaches, ardization bodies, government Vice-President from 1985-1987. tourist information offices, nat- and industry in the Caribbean, To register, please contact Mr. Mr. Spickernell, ural protected areas, health Central and South America. Susumu Akutsu (security- tourism and golf services. known as Spike, The event was attended by 65 [email protected]) indicating is remembered A future proposal for accommo- participants, including 18 spon- your name, organization, postal warmly by those dation and restaurants was announ- sored participants from national address, e-mail address and tel- who worked with ced for submission in 2010. standard bodies (NSBs) and nine ephone. him at both BSI UNIDO National Cleaner Pro- and ISO. He had The demand for new projects Avoiding toxicity was so high that the Chair called duction Centres from the region. been a leader and a of medical devices most dynamic for the rationalization of ISO/ The World Resources Institute officer in ISO for TC 228’s resources in order to introduced the GHG Protocol. The biological evaluation of many years both as a member of ensure quality and useful stand- Group discussions addressed medical devices – for which the Executive and Technical ards for the sector, consumers accreditation and financing, ISO has developed a series of Boards and as Vice-President. Mr. and other relevant stakeholders. standardization and the role of standards (ISO 10993) – is Spickernell was not only a highly Members from around the world NSBs, and related GHG issues in performed to determine the qualified professional but also a participate in ISO/TC 228, industry. The wide mix of back- potential toxicity resulting from caring, sensitive, generous human which currently has 53 partici- grounds ensured a rich exchange contact of the device’s materials being, full of energy and a won- pating member countries with of information and experiences. with the body. derful sense of humour. another 11 as observers. The This was the fourth event on Tourism Unit of the Directorate In the world of standardization, climate change and more are General Enterprise and Industry Mr. Spickernell is remembered as expected to be held, next in (European Commission) was one of the “fathers” of ISO 9000. South Asia and South-East Asia. recently admitted as liaison. The ISO 9000 family of Interna- For more information : tional Standards has become the The next meeting will take [email protected] international benchmark for quali- place in 2010 in Brazil. ty management systems. Latin America concerned Upcoming “ public Mr. Spickernell brought the United by climate change warning ” workshop A step forward in increasing the Kingdom’s Ministry of Defence outreach of the ISO 10993 series standard for Quality Assurance to ISO and the UN Industrial was made at a seminar held in BSI where it was published as BS Development Organization Jinan, China, in April 2009 in 5750. BS 5750 was one of the (UNIDO) jointly organized a conjunction with the plenary principal national inputs on which regional seminar on Green- meeting of ISO/TC 194, Biolog- the first edition of the ISO 9000 house gas (GHG) quantifica- ical evaluation of medical devic- family was based. Today, an esti- tion, reporting and verification, es. The seminar brought together mated one million organizations focusing on ISO 14064 and nearly 100 experts from the worldwide implement ISO 9001. ISO 14065, in San Jose, Costa medical device field (above). Rica in April 2009. “ Public warning ” is the subject Explosion of tourism of a workshop being organized The objective of the seminar projects As climate change draws grow- by ISO’s technical committee was to confirm the ISO 10993 ing attention, standards are ISO/TC 223, Societal security, series of standards as essential The ISO technical committee increasingly regarded as mak- working group WG 3, Com- and providing a basis for the ISO/TC 228, Tourism and relating a positive contribution in mand and control, coordination regulation of medical devices in ed services, held its April 2009 helping global efforts toward and cooperation, 8-9 September international markets. plenary in Cappadocia, Turkey, mitigation by promoting con- 2009 in Tokyo, Japan. hosted by TSE, the ISO member sistency, transparency and cred- Presenters from China, Europe, for the country (below). ibility on GHG. Public warning expressions Japan and the USA provided an such as sirens, alarms, signs, overview on existing national warning texts and colours alert legislations and emphasized the and notify those people at risk importance of collaboration and to take appropriate protective harmonization. They also provid- actions. The aim of the worked participants with a broad shop is to survey and summa- understanding of the role of bio- rize their use around the world logical safety evaluation in the and to clarify basic principles design and production process for effective public warning. of the medical device industry.

ISO Focus June 2009 3 © ISO Focus, www.iso.org/isofocus Guest View Cheryl L. White

heryl L. White is Cor- ISO Focus : From contamina- porate Vice President, tion to counterfeiting, the haz- CQuality at Baxter. ards in the healthcare industry Prior to assuming this are vast. How can ISO stand- position, Ms. White served as ards such as ISO 14971 (risk Vice President, Quality management for medical Management for Baxter’s devices) standard help? BioScience business in Westlake, California. She has Cheryl L. White : Implement- held senior positions within ing International Standards the BioScience business with such as ISO 14971:2007 (see direct supervision over global page 11) helps Baxter realize manufacturing facilities and business, economic and regu- product development for latory benefits. biopharmaceutical products, For example, utilization biosurgery and vaccines. She of ISO 14971 enables a shorter played a vital leadership development cycle by requir- position in the successful ing identification of an intended validation, staffing and use before any design actually licensure of the ADVATE begins, which prevents rework manufacturing facility in or clarification delays. The use Neuchatel, Switzerland. of a well-structured standard (such as ISO 14971) requires Before joining the company © Baxter Baxter to identify, verify, and in 1998, she managed quality monitor the key risk control control and quality assurance features of the product throughout the activities for Hybritech, at the time a product’s lifecycle. division of Eli Lilly and Beckman “Implementing By analyzing and tracking infor- Instruments. In addition, she spent mation on the continued effectiveness of nine years in academic research in the International Standards product, Baxter can make changes to fur- University of California system. such as ISO 14971:2007 ther strengthen and improve the product Ms. White is the executive sponsor of helps Baxter design. The detailed understanding of the Baxter’s Global Inclusion Council realize business, functioning and risk profile of our prod- and serves on the board of directors economic and ucts should, over the long run, reduce the of The Baxter International time required to execute design changes Foundation. She is a member of the regulatory benefits.” and new design extensions. Regulatory Affairs Professional Lastly, the growing importance of Society (RAPS) and the Parenteral standard adoption and utilization is evident Drug Association (PDA). in enforcement policies and industry trends throughout the global healthcare commu- Ms. White earned her master’s degree nity. The value of compliance to an inter- in business administration from the nationally recognized standard allows for University of California, Irvine, and a both manufacturers of healthcare products Bachelor of Arts in biology from the and regulators to speak the same language University of California, San Diego. and set consistent requirements.

4 ISO Focus June 2009 © Baxter © ISO Focus, www.iso.org/isofocus

Baxter’s Headquarters tems. As an example, ISO 14971:2007, Health and the United States Food and in Deerfield, Illinois. Medical devices – Application of risk Drug Association, provide a system that management to medical devices, gov- helps define customer requirements and About Baxter erns our approach to determination of product expectations, globally. As an International Inc. human factors and risk management on example, in our complex electromechan- our next-generation infusion pump. We ical devices we follow IEC 62304:2006, Baxter International Inc. designed our approach to management Medical device software – Software life (NYSE:BAX) is a global of the overall configuration of our prod- cycle processes, and sub-parts of IEC ucts around ISO 10007:2003, Quality 60601-1, Medical electrical equipment – healthcare company that, management systems – Guidelines for Part 1-x, General requirements for basic through its subsidiaries, assists configuration management. safety and essential performance. healthcare professionals and their patients with © Baxter treatment of complex medical conditions including hemophilia, immune disorders, kidney disease, trauma and other conditions. With 2008 sales of USD 12.3 billion, and approximately 48 500 employees, Baxter applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients’ lives.

ISO Focus : Because Baxter products are used in critical care environments, they have to be safe and effective every time, no matter what the challenges. What strategies does Baxter implement Baxter’s quality management system ensures the safety in order to ensure that hazards are and effectiveness of its products. identified and reduced? Why are standards important to this process and how have ISO standards helped? ISO Focus : In today’s tough economic ISO Focus : For the tenth consecutive times where cost-cutting and streamlin- year, Baxter was among the companies Cheryl L. White : Baxter uses a platform ing are required, how does Baxter chosen for the 2008 Dow Jones Sus- of International Standards to assure our ensure product quality is not compro- tainability Index for the company’s quality systems and design processes mised? How effective are International ability to combine sustainability with conform to a generally accepted set of Standards in ensuring the safety and profitability. What is, in your view, the practices for identification and man- quality of your products, which are business case for investing in socially agement of product risks. These stand- used millions of times a day by patients responsible actions that may not be ards represent a recognized baseline of worldwide? immediately beneficial to productivity acceptable practice for recognition and or the bottom line or economic success mitigation of risk. Cheryl L. White : Baxter’s quality in a competitive market? What added Besides ISO 13485:2003, Medi- management system conforms to ISO value would you see in the Internation- cal devices – Quality management sys- 13485:2003 and ISO 9001:2008 among al Standard giving guidelines on social tems – Requirements for regulatory other standards. This system sets clear responsibility being developed by ISO? purposes, and ISO 9001:2008, Quality expectations for design and produc- (cf. ISO 26000) management systems – Requirements, tion of our products in order to ensure which are used primarily as a basis for safe and effective products in the mar- Cheryl L. White : At Baxter sustainabil- our quality management system, we also ket place. ity makes good business sense. Baxter’s use standards that are recognized as aids These standards, coupled with approach to sustainability helps the com- in the deployment of those quality sys- requirements from many Ministries of pany gain a competitive advantage, drives

ISO Focus June 2009 5 © ISO Focus, www.iso.org/isofocus

Guest View

financial savings, differentiates the company and enhances its reputation. Some examples of how sustainability helps Baxter include: • Enhancing our ability to attract high caliber and diverse talent in an increasingly competitive marketplace • Helping us save more than USD 82 million in 2007 through environmental initiatives such as energy conservation, water conservation and recycling • Increasing global access to healthcare through grants from The Bax- ter International Foundation and the donation of critical health care products for worldwide distribution • Encouraging and celebrating a culture of employee volunteerism (both personal and company sponsored). Further development of ISO standards in the area of social responsibility can only help to ensure companies are taking a responsible approach to conducting business, and their commitment to sustainability will help them consider the short and long-term social, economic and environmental impacts of the © Baxter work we all do and products and serv- Medication delivery at Baxter’s manufacturing plant in Sao Paulo, Brazil. ices that we provide.

ISO Focus : What hazards do you see Employee Margarita Chavez checks materials from suppliers at a drug delivery facility the healthcare industry confronting in in Round Lake, Illinois. the coming years? What new standards would Baxter like to see coming out of ISO?

Cheryl L. White : One of the real issues we see our industry wrestling with in the future is that of product counterfeiting requiring clear guidelines for product identification. Many of our products represent significant financial value in small packaging and we have seen a rise in the occurrence of counterfeiting where pirates are making real investments in equipment in order to create replicas of Baxter’s products. We are taking significant steps globally to protect our supply chain against this threat and are confident that we will be able to reduce the risk to our products, but this problem ultimately requires effective industry-wide and government collaboration to be addressed.

by Kevin W. Knight AM*, Chair, ISO working group on Risk Management

ome would suggest that the global financial crisis was caused by a Sfailure of risk management rather than the failure of boards and top management to effectively manage risk. The future ISO 31000, Risk management – Principles and guidelines, is expected to help industry and commerce, public and private, to confidently emerge from the crisis. This much-awaited International Tackling Standard is expected to be published in the third quarter of 2009. Without risk, there is no reward or progress. Unless risk is managed effective- hazards ly, organizations cannot maximize opportunities and minimize threats. Risk is all about uncertainty, or more importantly, the effect of uncertainty on the achievement of objectives. This is where ISO 31000 is clearly different from existing guidelines in that the emphasis is shifted from something happening – the event – to the effect on objectives. Every organization has objectives to achieve, and in order to achieve them, any uncertainty that could interfere with their realization must be effectively managed.

Applicable and adaptable to all ISO 31000 sets out principles, a framework, and a process for the management of all forms of risk, including safety and environment, in all organizations, regardless of size. It does not mandate a one-size-fits-all approach, but emphasizes tailoring the principles and guidelines to the specific needs and structure of the organization. Following a list of terms and def- initions, the standard sets out 11 princi-

* Member of the General Division of the Order of Australia (AM).

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Main Focus

not be an add-on, or a separate activity divorced from the mainstream management of the business.

A strategic process The risk management process contained in ISO 31000 follows the well worn lead set by the Australian and New Zealand Standard AS/NZS 4360, which consists of : • Communication and consultation • Establishing the context ples to be addressed in order to effective- Commitment of • Risk assessment consisting of the ly manage risks and achieve objectives. top management The principles need to be reviewed by the three steps of identification, analy- board and top management so they may The overarching component of sis and evaluation reflect the organization’s policy. the framework is the mandate and com- • Risk treatment mitment of the organization’s board and The next section looks at the top management to the implementation, • Monitoring and review. framework needed to provide the foun- review and continual improvement of how The process set out needs to dations and arrangements that will embed risk is managed. The end goal : to ensure become an integral part of how busi- the management of risk at all levels of risk is fully focused on the achievement ness is managed at all levels. It must be the organization. It calls for risk manage- of objectives. This focus on objectives tailored to the business processes and ment components to be adapted into the is imperative if enterprise risk manage- woven into the culture and practices of existing management system in order to ment (ERM) is to be achieved by a com- the organization that make it uniquely ensure ownership of the policy and proc- mon language and process throughout different from its competitors. ess by management and staff. the organization. All activities should be traceable by way of records that provide the foun- About the author dation for improvement in methods and “ Risk needs to become tools, as well as in the overall process. Kevin W. Finally, an informative annex sets Knight AM* is an integral part of how out the attributes of enhanced risk man- Chair of the things are managed. ” agement for those organizations that have ISO working been working on managing their risks for group develop- some time and may wish to strive for a The framework calls for a clear ing the new ISO higher level of achievement. 31000 risk man- understanding of the context in which agement stand- the organization operates. The risk man- ard and the revi- agement policy must clearly state the Representing sion of ISO/IEC organization’s commitment to the man- Guide 73 (risk agement of risk. More importantly, the the very best management vocabulary), and a found- standard requires organizations to iden- The working group that produced ing member of the Standards Australia/ tify risk owners to ensure accountabili- ISO 31000 contained experts from some Standards New Zealand Joint Technical ty and authority. For example, the stand- 28 countries representing all continents Committee OB/7– Risk management. ard seeks to differentiate between those (except Antarctica). All meetings of the He is well known through his very who are “ accountable ” for managing risk working group had strong attendance, rang- active work in the development of risk (those persons with a liability, either cor- ing from 40 to 60 delegates depending on management standards and has been porate or legal, for their decisions or lack the meeting location, with a significant active in furthering the risk management of decision) and those who are “ responsi- core group who participated in all meet- profession and the professional develop- ble ” for specific tasks (those persons with ings. It is precisely because of this core ment of its practitioners, both worldwide an obligation to carry out an instruction group, ably supported by the other expert and throughout the Asia-Pacific Region from a competent authority). delegates and backed up by the national in particular, over the past 25 years. The framework also sets out mirror committees, that ensures ISO 31000 E-mail : [email protected] how the management of risk is to be represents the very best of contemporary woven into the organizational fabric. risk management thought. * Member of the General Division Risk needs to become an integral part of the Order of Australia (AM). of how things are managed; it should

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information, coordination and cooperation for emergency management – Requirements • ISO 22322, Public warning 1) • ISO 22397, Private and public part- nerships 1) • ISO 22398, Guidelines for exercises and testing 1) • ISO 22399, Guideline for incident preparedness and operational continuity management. Two of these work items are described in detail below.

Future management system for preparedness and continuity As business has become increasingly lean, controlled and organized, a growing need to manage continuity of operations effectively has been identified. But as the risks that may result from interruptions are so varied as to be unforeseeable, the problem must be the role of standardization in the secu- approached in a structured fashion. Enhancing rity field. One important decision was The first deliverable of the com- to put ISO/TC 223 into action. societal resilience mittee ISO/PAS 22399 was published in In 2005, the chairmanship of the November 2007, describing a guideline for committee was taken over by the Swed- incident preparedness and operational conti- ish Standards Institute (SIS). To better nuity management. ISO/TC 223 has decid- by Dr. Stefan Tangen, Secretary reflect its ambition of taking a broader ed to take the next step within the field and of ISO/TC 223, Societal security approach toward disruptive incidents that is now fully engaged in the development threaten civil society, ISO/ TC 223 was of a management system standard which he sinking of the Russian subma- renamed Societal security. The scope of will be called ISO 22301, Societal secu- rine Kursk to the bottom of the the committee is very broad, covering all rity – Preparedness and continuity Man- TBarents Sea in 2000 can be cited phases of man-made or naturally caused agement Systems – Requirements. as a major impetus for the formation of disaster situations. ISO technical committee ISO/TC 223. This management system stand- Since its first meeting in Stock- The international salvage operation that ard will provide a tool to allow organ- holm in May 2006 the membership of followed the accident provided painful izations to consider their preparations ISO/TC 223 has grown steadily and today evidence that the international commu- for responding to operational disrup- consists of 37 participating (P) member nity lacked the tools necessary to coop- tions in an emergency situation. It will countries with another 18 as observers erate effectively in emergency situations, enable them to manage and survive the (O) and several liaison organizations. resulting in an initiative from the Rus- incident and take appropriate action to A series of ISO standards is being devel- sian standards organization, GOST, to help ensure the organization’s continued oped that will enhance societal resilience establish ISO/TC 223. Originally titled viability. The requirements in the stand- from various perspectives : Civil defense, the committee was creat- ard are generic and intended to be applied to standardize international emergen- • ISO 22300, Vocabulary cable to all organizations (or parts there- cy procedures. of), regardless of type, size and nature • ISO 22301, Preparedness and conti- of the organization. The initiative lay dormant for nuity management systems – Require- The scope of ISO 22301 is almost some time. However, terrorist actions, ments including the 9/11 attacks on New York identical to the British Standard BS ISO 22311, Video surveillance for and Washington, as well as a surge in • interoperability natural disasters in recent years, led ISO to conduct a large-scale assessment of • ISO 22320, Command and control, 1) Preliminary work items.

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25999-2:2007, Specification for Business Continuity Management. However, its content is based on all existing national standards on the subject. The approach of taking the “ best of the best ” of existing standards was very successful in the development of ISO/PAS 22399, and the committee is convinced that this Participants at the 6th plenary meeting of ISO/TC 223 in Bali, Indonesia approach will lead once again to a high quality standard. er management systems while simplify- and Initial Recovery Assistance ” from ing the implementation of the standard. the International Federation of the Red The publication of ISO 22301 is expect- Cross and Red Crescent Societies ; and “ A growing need to ed in 2011. PAS 55, Asset Management, from the manage continuity of British Standards Institution (BSI). operations effectively has The committee also discussed Future standard for which technological capabilities are nec- been identified. ” emergency management essary within the field and how product The main objective of emergen- standards can support the management During recent years we have seen cy management is to save lives, reduce standards that are currently under devel- the development of a number of national impact on society’s vital functions and opment. This may very well lead the com- standards indicating a clear market need limit adverse effects. To achieve this, mittee to expand its work programme for ISO 22301. However, this provides emergency organizations need to be able with interesting new work items. a new problem for global corporations to interact and share information with one Efficient management of crises in that it is costly and cumbersome to another. ISO 22320 will specify the fun- typically results from having relevant provide proof of compliance with mul- damental requirements which provide the tools in place that function in normal day- tiple national standards. The variety of basis for effective minimum command to-day activities and that provide added initiatives in the field has also caused a and control within an emergency response value in preventing, managing, and recov- great deal of uncertainty. organization. These include command ering from a disruptive incident. Inter- An ISO standard will bring an and control structures and procedures, national Standards play a critical role in end to the confusion and it is expect- decision support, traceability, informa- ensuring security and have the potential ed that ISO 22301 will be adopted as tion management, and interoperability to enhance the resilience of society and a national standard in numerous coun- for an emergency situation. its constituent elements. tries. Further, ISO 9001:2008 and ISO ISO 22320 also establishes require- 14001:2004 have been reviewed in the ments for emergency management oper- work to ensure compatibility with oth- ational information which includes pro- Scope of ISO/TC 223 cesses, systems of work, data capture and International standardization in management. The goal is to produce time- the area of societal security aimed at About the author ly, relevant and accurate information sup- increasing crisis and continuity manage- porting the command and control of the ment and capabilities through technical, Dr. Stefan Tan- organization as well as coordination and human, organization, operational, and gen is the Sec- cooperation with other involved parties. management approaches ; operational retary of ISO/ Publication is scheduled for 2011. functionality and interoperability ; and TC 223, Soci- awareness amongst all interested parties etal security, and stakeholders. and a project New areas ISO/TC 223 will work toward manager at the Ambassador Krister Kumlin, sen- international standardization that pro- Swedish Stand- ior adviser to the Swedish Civil Contin- vides protection from and response to ards Institute the risks of unintentionally, intentionally, (SIS). He has gencies Agency, has chaired the com- and naturally caused crises and disasters previously been mittee since its first meeting, while the that disrupt and have consequences on the secretary of ISO/TC 184/SC 2, Swedish Standards Institute is respon- th Robots and robotic devices, and has sible for the secretariat. The 7 plenary societal functions. The committee will worked with numerous Swedish mirror meeting was held in Paris in late May use an all-hazards perspective covering committees. Before joining standardiza- this year with about 100 participants. the phases of emergency and crisis man- tion he worked as a senior researcher at Several new topics were presented dur- agement before, during and after a soci- the Royal Institute of Technology in ing the meeting including “ Guidelines etal security incident. Stockholm. Dr. Tangen holds a PhD in for the Domestic Facilitation and Reg- production engineering. ulation of International Disaster Relief

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no medical device – or any other product or process – can be completely safe, there is a need for risk management to support manufacturers, clinicians, regulatory authorities and the public in making decisions regarding the health and safety of specific products. The two editions of this standard present the fundamental risk concepts, and they have supported the mission of medical device safety and health for over a decade.

A risk management standard Since the 1960s, many medical device standards have been effective in ensuring the safety of the devices covered by these standards. Certainly, the need for specific technical standards remains, but the increased sophistica- tion of the patient care environment, as well as the hardware and software incorporated into medical devices, impos- es increasing demands upon medical device manufacturers and the users of those devices.

“ Since no medical device – or any other product or process – can be completely safe, there is a need for risk management. ”

foremost a management standard, cov- Ensuring safety ering the entire life cycle of all types of and efficacy of medical devices. That increased complexity, cou- Within the standard is included pled with wide recognition that there is medical devices a defined risk management process. All no absolute certainty of safety, demands of the elements of the risk management that the concept of risk must be addressed process must be in place to be effective. in technical standards. Indeed, some An excellent indication of the acceptance aspects of safety can be addressed only by Alfred M Dolan, Convenor, received by the standard is its unani- through implementation of a risk man- and Stan Mastrangelo, member mous approval by ISO, the Internation- agement approach. of Joint ISO/IEC working al Electrotechnical Commission (IEC), To maximize safety in the 21st group WG 1, Application of risk the European Committee for Standard- century, manufacturers need to develop management to medical devices ization (CEN) and the European Com- products that comply with product spe- mittee for Electrotechnical Standard- cific standards and they need to imple- nternational Standard ISO 14971:2007, ization (CENELEC). ISO 14971 has ment a robust risk management process Medical devices – Application of risk also been implemented by internation- that ensures medical devices are safe Imanagement to medical devices, is al medical device regulatory bodies in and effective. Both elements are neces- the definitive worldwide standard for various ways. sary to ensure that risks associated with the medical device sector. It is first and Uncertainty is ubiquitous. Since a medical device are addressed.

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ISO technical committee ISO/ of ISO 14971:2007, Medical devices – Risk management TC 210, Quality management and cor- Application of risk management to medi- concepts responding general aspects for medical devices. The standard builds on well- cal devices, was formed in 1994, and established risk management principles ISO 14971 is a management the working group on risk management developed over centuries, as well as on standard. Management responsibility was established at the same time in rec- the work of other national and interna- is identified as the initial – and the key ognition of the need for a risk manage- tional risk frameworks, and provides a – requirement for successful management approach to be applied to medi- recognized process for manufacturers of ment of risks. The top management of cal devices. That working group, which medical devices. the manufacturer is required to : later became the current Joint IEC/ISO All the key principles of risk man- • Establish a risk management process, working group WG 1 on risk manage- agement apply – the standard provides a which includes defined elements ment, has published three documents, management system and specifies that the Provide adequate resources for the the first standard being on risk analysis • steps of hazard identification, risk estima- risk management team in 1998 (ISO 14971-1). tion, risk evaluation, risk control, and risk The current definitive risk man- review must be included in any manufac- • Provide appropriate personnel to car- agement document is the second edition turer’s risk management process. ry out the process • Establish a policy that identifies acceptable risk levels About the authors • Review the suitability of the process on a regular basis. Stan Alfred M Mastrangelo is Dolan is a fac- The risk management process a member of the ulty member of defined within the standard must con- Joint ISO/IEC the Virginia tain the elements of risk analysis and risk working group Polytechnic evaluation which comprise risk assess- on the Applica- Institute and ment, risk control and production and tion of risk State University post-production information. These are management to in the USA. He summarized in the figure below, which medical devices is also the Sam- is taken from ISO 14971. of ISO/TC 210, uel Lunefeld For each medical device there Quality man- Professor Emer- is a requirement that a risk manage- agement and corresponding general itus in Clinical Engineering at the Uni- ment plan be developed in accordance aspects for medical devices. He is also versity of Toronto. Prof. Dolan is Con- with the risk management process noted the committee’s liaison with the ISO venor of the Joint ISO/IEC working above. A critical component of the plan Working Group on Risk Management group on the application of risk manage- includes setting the level of acceptable developing the future ISO 31000 ment to medical devices of ISO/TC 210, standard. Dr. Mastrangelo is a member Quality management and corresponding risk for that device, based on the poli- of the faculty for the Center for general aspects for medical devices, cy for risk acceptability established by Applied Health Sciences at Virginia which is responsible for writing ISO management. Polytechnic Institute and State 14971:2007. The plan also describes how each University in the USA. element of the risk management process

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Risk management

Risk assessment

Risk analysis example, the risk management proc- The medical device quality management • Intended use and identi cation ess requirements of ISO 14971 and the standard (ISO 13485) incorporates the of characteristics related current Good Manufacturing Practice standard indirectly by identifying risk to the safety of the medical device (cGMP) have many parallels. The gen- management as a component for prod- • Identi cation of hazards eral requirements call for a risk manage- uct realization. • Estimation of the risk(s) for ment process that includes risk analysis, each hazardous situation Another example includes the risk evaluation, risk control, and produc- extensive implementation of the ISO tion and post-production monitoring. 14971 risk management process into the The GMP requirement 820.30(g) calls Risk evaluation third edition of IEC 60601 on medical for design validation that includes soft- electrical equipment. Risk management ware validation and risk analysis where – and ISO 14971 specifically – is cited appropriate. Risk control hundreds of times in many clauses. The standard also is cited in requirements or • Risk control option analysis • Implementation of risk referenced in specific clauses in other control measure(s) standards, covering such diverse areas as • Residual risk evaluation “ ISO 14971 has programmable medical electrical systems • Risk/bene t analysis • Risks arising from risk quickly become (IEC 60601-1-2) ; usability (IEC 60601- control measures 1-06) ; biological evaluation of medical • Completeness of risk control the worldwide standard devices (ISO 10993-18) ; clinical investi- for risk management gation for human subjects (ISO 14155) ; cardiac valve prosthesis (ISO 5840) ; and Evaluation of overall residual for medical devices. ” risk acceptability anaesthetic equipment. It is clear that ISO 14971 has quickly become the worldwide standard Risk management report When conducting risk analysis for risk management for medical devic- according to the requirement, manu- es. In this way it is helping manufactur- facturers need to identify possible haz- ers and other users to ensure the safety Production and post-production ards associated with the design in both and efficacy of medical devices used in information normal and fault conditions. The risks health care facilities worldwide. associated with those hazards, including Figure 1 – A schematic representation of those resulting from use error, are to be the risk management process. calculated in both normal and fault conditions. If any risk is judged unaccept- able, it should be reduced to acceptable is to be achieved for that device. Ongo- levels by appropriate means. Moreover, ing monitoring and review of risk man- corrective and preventive action taken agement is incorporated in a require- in accordance with 820.100 (CAPA) ment for generation of production and must be commensurate with the risks post-production information. This step encountered. involves setting up a systematic proce- The standard has been approved dure for reviewing information gener- as a European Standard, and can there- ated during production and in-service fore be used in meeting medical device experience, and then moving it into a essential requirements in Europe. In feedback process. Japan it has been translated into a Japa- nese Industrial Standard and effectively incorporated into the country’s law. International It will therefore form part of the medi- harmonization cal device regulatory process adminis- Harmonization in the application tered through Japan’s Ministry of Labour of ISO 14971 as the medical device risk and Welfare. management standard has developed rap- In International Standards, ISO idly through both standards and interna- 14971 has been incorporated or integrat- tional regulatory activity. International ed in various ways throughout a wide medical device regulatory bodies cur- variety of medical device standards. The rently incorporate requirements that are standard has been successful in effective- included in that standard or are consist- ly and efficiently harmonizing risk man- ent with the standard. In US Food and agement throughout the sector and has Drug Administration requirements, for met the needs of thousands of entities.

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Dave Osborn, Secretary of the ISO Pandemic preparedness – subcommittee responsible for ISO/TR 13154, comments : “ The publication of New ISO report on use of the technical report is very timely given fever screening equipment the current outbreak of H1N1 in several regions of the world. Because panic can lead to misdirected energies that waste previous resources, the ISO technical tool for pandemic prepar- report deserves high marks for provid- edness. The prime objec- ing an important first step in the face of tives of pandemic planning outbreaks of influenza and other infec- are to save lives, reduce the tious diseases, such as severe acute res- health impact of a pandem- piratory syndrome (SARS), tuberculosis, ic and minimize disruption anthrax and methicillin-resistant Staphy- of health and other servic- lococcus aureus (MRSA), and other bio- es, while maintaining busi- logical or bacterial agents whose early ness continuity and reduc- detection is vital. ” ing the general disruption ISO/TR 13154:2009 was derived, to society that is likely to in part, from ISO member for Singapore’s ensue. (SPRING) technical reference 15 pub- The ISO technical lished in two parts under the general title, report will contribute to Technical reference for thermal imagers the efficient and effective for human temperature screening. The use of thermographs used SPRING technical reference was created at sensitive locations for as a result of the Singapore experiences screening individuals for during the SARS outbreak of 2003. fever, which could indicate ISO/TR 13154:2009, Medical elec- that they carry a virus. Such trical equipment – Deployment, imple- screening will enable public mentation and operational guidelines health authorities to formu- for indentifying febrile humans using a late appropriate measures, screening thermograph, has been prepared from school closure to quar- by a Joint Working Group of ISO techni- antine of suspected cases, cal committee ISO/TC 121, Anaesthetic thereby reducing exposure and respiratory equipment, subcommit- to the virus and limiting its tee, SC 3, Lung ventilators and related transmission. equipment and IEC technical commit- The images below of the newly identified ISO/TR 13154:2009 tee IEC/TC 62, Electrical equipment in H1N1 influenza virus were taken in the CDC provides general guidelines for the deploy- medical practice, subcommittee SC D, Influenza Laboratory. ment, implementation and operation of Electromedical equipment. The tech- © Centers for Disease Control and Prevention a screening thermograph intended to be nical report is a companion document used for screening fever. A screening to IEC 80601-2-59:2008, which gives thermograph can be used in locations the technical requirements of a screen- by Elizabeth Gasiorowski-Denis, such as entrances to : ing thermograph, also developed by the Editor of ISO Focus • Hospitals and clinics, including emer- Joint Working Group. gency rooms A new ISO technical report on how • Critical infrastructure facilities to make the best use of medical equipment for fever screening at key locations such • Workplaces as international airports will help public • Schools health authorities to contain the spread Government buildings, including of infectious diseases such as the H1N1 • police and fire stations, as well as influenza virus and so prevent them from access to developing into pandemics. ISO/TR 13154:2009, Medical elec- • Public transport. trical equipment – Deployment, imple- A screening thermograph can also mentation and operational guidelines play an important epidemiological role for indentifying febrile humans using a in defining the geographical boundaries screening thermograph, is a useful new of an outbreak.

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Preventing infection are transmitted by skin-to-skin con- Condom testing tact, since the condoms may not cov- Sexually transmitted diseases er the infected areas contributes (STDs) can be transmitted in two pri- mary ways. HIV, gonorrhoea, chlamy- • Male latex condoms are the only con- to disease dia and trichomoniasis are transmitted traceptive proven to be effective in when infected semen or vaginal fluids preventing both unwanted pregnan- prevention contact mucosal surfaces. Genital ulcer cy and sexually transmitted diseas- diseases such as genital herpes, syphilis es, including HIV. and human papillomavirus are transmit- by Dr. Eng Long Ong, ted through contact with infected skin or Chair of ISO/TC 157, mucosal surfaces. Why the need Mechanical contraceptives In June 2000, the US National for testing ? Institutes of Health (NIH) and the Cent- To help ensure that condoms are The HIV/AIDS epidemic that ers for Disease Control and Prevention effective both for contraceptive purposes began in the early 1980s has changed the (CDC) conducted an extensive review of and in the prevention of STDs, ISO/TC lifestyles of people all over the world, all available published studies with the 157 has developed standards requiring and it has also brought about important participation of the World Health Organ- that condoms fit the penis properly, are changes in the work of ISO technical ization (WHO). The key findings of the free from holes, have adequate physical committee ISO/TC 157, Mechanical con- report reviewing the evidence available strength so as not to break during use, are traceptives. AIDS has killed more than then were as follows : correctly packaged for protection during 25 million people since 1981. Some 33 • Used correctly and consistently, male storage, and are correctly labelled. million people in the world now live with latex condoms significantly reduce HIV (Human Immunodeficiency Virus), the risk of HIV infection the virus that causes AIDS (Acquired Immune Deficiency Syndrome). • Used correctly and consistently, male “ Condoms are now latex condoms reduce the risk of trans- Once used primarily for family mission of gonorrhoea, chlamydia and widely employed for planning purposes, condoms are now trichomoniasis widely employed for their efficacy in their efficacy in preventing the spread of HIV/AIDS, • Male latex condoms are imperme- preventing the spread as well as protecting against a number able to infectious agents contained of HIV/AIDS. ” of other sexually transmitted diseases. in genital secretions, including the This shift in the motivations and expec- smallest viruses tations of users impacts the focus of • Male condoms may be less effective ISO/TC 157. in protecting against those STDs that Since its first meeting in 1975, ISO/TC 157 has expanded its scope to cover all areas of mechanical contraceptives (which are classified as medical devices in many countries). They vary from the single-use, disposable male condom, which can be purchased over the counter or given away free, to multi- ple-use devices such as the intra-uterine device (IUD), which is normally available only by prescription and requires correct insertion and monitoring by a medical specialist. The published standard for male latex condoms, ISO 4074:2002, Natural rubber latex condoms – Requirements and test methods, is the most important output of the technical committee. Providing the basis for much of the world’s trade in condoms, the standard is used by procurement agencies and HIV prevention and family planning agencies, and is referenced extensively by the WHO in its purchasing specifications for condoms.

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Main Focus

Additional guidance may be found in ISO 16038:2005, Rubber condoms – Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms. Condoms are non-ster- ile medical devices. Manufacturers have taken appropriate precautions to minimize microbiological contamination of the product during manufacturing and packaging.

“ Condom manufacturers

The published standard for male latex condoms, ISO 4074:2002, Natural rubber latex must ensure that condoms – Requirements and test methods, is the most important output of ISO/TC 157. their products meet the regulatory In addition to ISO 4074, the pub- Product quality and lished standard for IUDs is ISO 7439:2002, continual improvement requirements. ” Copper-bearing intra-uterine contraceptive devices – Requirements and Most of the products under ISO/ tests. The standard for diaphragms ISO TC 157 are classified as medical devices. 8009:2004, Reusable natural and sili- This means that these products should be Over the past decade, manufac- cone rubber contraceptive diaphragms produced under a quality management turers of latex condoms have continued – Requirements and tests. These two system using design controls. Reference to make product improvements based on standards are widely regarded and used should be made, for example, to : research and development findings and in their respective markets. • ISO 9001:2008, Quality management on changes in ISO 4074, which is used systems – Requirements in buyers’ purchasing specifications. To compete in the global market, manufactur- • ISO 14971:2007, Medical devices – About the author ers have improved their production lines Application of risk management to by using better latex formulations, incor- medical devices Dr. Eng Long porating a wide range of design modifi- Ong obtained • ISO 13485:2003, Medical devices – cations such as varying shapes, colours his BSc (Hons) Quality management systems – Require- and flavour, and meeting the require- from the Univer- ments for regulatory purposes. ments of specifications. sity of Malaya and a PhD from Queen Mary Stringent regulations College, Univer- sity of London. Given the need to protect public He is former health and safety, medical products are Deputy Director subject to stringent regulations. Condom General of the Malaysian Rubber Board manufacturers must ensure that their prod- and the former Deputy CEO of the ucts meet the regulatory requirements in Malaysian Rubber Export Promotion terms of efficacy, quality and suitability Council. He is currently Chair of ISO/TC for their intended purpose. Regulators 157, Mechanical contraceptives, and also Synthetic (polyurethane) condom (left) include the US Food and Drug Admin- the Chair of ISO/TC 45/SC 4, Miscella- Natural rubber latex condom (right) istration (FDA), the European Commis- neous rubber products. sion and the procurement specifications He is a Fellow of the Academy of Scienc- of donor agencies providing free or low- es Malaysia (FASc), Malaysian Institute cost condoms. This makes involvement of Chemistry (FMIC), Institute of Materi- of regulatory agencies in the work of als Malaysia (FIMM) and the Plastic and ISO/TC 157 essential. Rubber Institute of Malaysia (FPRIM). Dr. Ong has published widely in areas of For the male and female donating rubber science and latex dipped products. programmes, this requires the involve- He has written more than 150 peer- ment of stakeholders such as the WHO, reviewed papers, conference papers, book family planning, educational and char- chapters and monographs. itable agencies, HIV prevention and

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Current activities of ISO/TC 157

ISO technical committee ISO/TC 157 currently includes are effective for contraceptive purposes and in family planning agencies, and consum- 27 participating (P) member countries with another preventing the transmission of STDs. er organizations such as Consumers 20 as observers (O). This represents a healthy bal- WG 18, Female condoms. Develops International International. ance between geographic regions, between manufac- Standards for female condoms. The standards will In addition to the above inter- turing and consumer countries, and between devel- define requirements to ensure that female con- est groups, ISO/TC 157 maintains liai- oped and developing countries. doms are effective in preventing pregnancy and son with Consumers International (CI), ISO/TC 157 does not have any subcommittees, sexually transmitted infections when used correctly Department for International Develop- and the work is handled by several active work- and consistently. Standardization of female con- ment (DFID), European Commission ing groups. The following list provides an overview doms is becoming more relevant, now that more (EC), and International Planned Par- enthood Federation (IPPF). The com- of the complexity and scope of the work under- manufacturers are entering the market, and the mittee also works closely with the Unit- taken by ISO/TC 157 : demand for the product is growing. ed Nations Population Fund (UNFPA), WG 3, Intra-uterine devices. Currently revising the WG 19, Holes detection. Will work to standardize Family Health International (FHI), and International Standard for copper-bearing intra-uter- the electrical test method and the rolled water the Programme for Appropriate Tech- ine contraceptive devices, ISO 7439 : 2002. WG 3 test. It has been reported that the rolled water nology in Health (PATH). works closely with the World Health Organization and test and European electrical test were found to Until recently, the condom stand- other international bodies. The revision takes into be equivalent. ard used in the European Union was a consideration the safety, efficacy and performance WG 20, Clinical trial. Will develop a series of stand- European Committee for Standardiza- of framed copper intra-uterine devices. ards under a general title Condoms – Guidance on tion (CEN) standard that differed from WG 10, Burst requirements. Primarily resolves issues clinical studies. The document will be divided into the ISO standard. This situation has now relating to the specification of minimum burst three parts as follows : been resolved, with the CEN standard replaced by ISO 4074:2002 under the pressure and burst volume requirements including Part 1 : General consideration for studies based Vienna Agreement, where the ISO tech- effects of condom dimensions and design. on self-reports nical committee has the lead. The reverse Part 2 : Male condoms – In-use studies of slip- WG 12, Determination of the amount of lubricant. situation exists with IUDs, where the page and breakage Currently investigating a promising new method for standard in use is ISO 7439:2002, but lubricant recovery via an inter-laboratory study. It is Part 3 : Female condoms. the CEN committee has the lead. hoped to provide an acceptable method to replace Aims to provide insight into the design and execu- the current method used in ISO 4074:2002. tion of clinical studies and to compare the per- WG 13, Stability assessment. Works on develop- formance characteristics of new synthetic condoms, Value of the work ing suitable shelf life testing conditions that cor- male condoms made of natural rubber latex and ISO/TC 157 will continue to be relate with changes in condom properties seen in female condoms. In particular, these studies are involved in the development and refine- real-time studies. Important properties that can designed to look at condom slippage and break- ment of standards for all mechanical change with shelf life have been identified, includ- age during use. This guidance standard also pro- contraceptives and to produce appro- ing bursting pressure and volume, freedom from vides direction on the statistical analysis of data priate guidance documents for manu- holes and pack integrity. as well as interpretation of these results by man- facturers, regulators and procurement ufacturers and regulatory bodies. WG 14, Guidance on the use of ISO 4074 and ISO agencies. Members of ISO/TC 157 will continue to monitor developments in the 23409. Develops and maintains guidance stand- WG 21, Determination of nitrosamines. Works on world condom market and the ongoing ards on the use of ISO 4074:2002 and future developing an International Standard to deter- evaluation of methodologies for, and ISO 23409 in the quality management of natu- mine the migration of nitrosamines and nitrosat- data from, clinical studies, as these ele- able substances from natural rubber latex con- ral rubber latex condoms and synthetic condoms ments impact on the future direction of doms into various media. respectively. The guidance standard on the use standardization. of ISO 4074 was published as ISO 16038:2005 WG 22, Latex barrier membranes (dams). This stand- The explosion in infection rates and has been proposed for a revision. The revi- ard provides requirements for latex barrier mem- in various parts of the world from the sion of ISO 16038 is on pace with the devel- branes (dams) for prophylactic use. These include HIV and other STDs has not only con- opment of standard on rubber latex condoms allowable materials, dimensions, surface finish, tributed to a major increase in demand (ISO 4074). taste and smell, thermal stability, packaging and for male condoms, but has highlighted WG 15, Additional lubricants. Develops test methods labelling as well as the physical properties such as the value of the work of the committee suitable for studying the effect of additional lubri- elongation and tear and rupture resistance. in a way that could not have been pre- cants on physical properties of condoms. WG 23, Natural rubber latex condoms. The working dicted in the early 1980s. It was recently decided to change the title of the tech- WG 17, Synthetic condoms. Produces International group is currently in the process of revising ISO nical committee from Mechanical con- Standards for male condoms made from synthetic 4074, part of a process of continual improvement traceptives to Non-systemic contracep- materials. As the physical properties of synthetic to the quality and applicability of the standard. tives and STI barrier prophylactics. materials differ from traditional latex rubber, the WG 24 , Tubal ligation/Fallopian ring. A newly cre- requirements of the standard will include a dif- ated working group that has been tasked to devel- ferent approach to ensure that synthetic condoms op a new standard.

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Main Focus

Fire safety saves lives

by Björn Sundström, Chair, and health and environmental issues as well Magdalena Di Carlo, Secretary as safety, and the standards developed should save lives, reduce fire losses and of ISO/TC 92, Fire safety bring substantial cost savings in design Fires occur every day all over through the use of appropriate fire safe- the globe. In the developed world, fire ty engineering. typically claims the lives of 10 to 20 ISO/TC 92 standards are used by people per one million population each national regulators within the Europe- year, and the large majority of fatalities an Union (EU) and in individual coun- occur in buildings. Direct property loss- tries’ building codes (e.g. Australia), as es amount to between 0,1 % and 0,2 % well as international organizations such of GDP per year. Together with the costs as the International Maritime Organiza- of emergency services, fire protection tion (IMO), and by fire safety engineers in buildings, fire insurance administra- throughout the world. ISO/TC 92 stand- tion and resulting losses to commerce, ards are of particular value to developing the total cost approaches 1 % of GDP. If countries. In addition to supporting fire we add figures for other sectors such as safety design and providing for advanced transportation, it is clear that measures measurements, there are also standards to reduce fires through standardization that are simple to use at low cost. These globally are a very good investment in standards are suitable for use in prescrip- life and property safety. tive regulations and provide an easy route ISO technical committee ISO/TC to increased fire safety. 92, Fire safety, is a horizontal commit- Fires in buses are quite common. tee, addressing all aspects of fire safety. A special hazard arises from fires Fire initiation and growth The committee produces international- in tunnels. ly accepted standards and documents on A fire starts when a product is fire testing, measurements of fire param- exposed to an ignition source – for exam- eters, fire safety engineering and related ple a match or a burning waste paper bas- topics. The work of ISO/TC 92 concerns ket – powerful enough to cause ignition.

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There might be a flame spread along Keeping a fire in place linings and floor coverings. The heat- Fires can of course develop ful- release rate from the involved products ly and spread to the rest of the build- will determine the size of the fire. There ing. One strategy is to stop the fire from will be production of smoke and of tox- going through a construction, for instance ic gases. A particular danger is carbon with a fire door. Standards for testing the monoxide, produced when a fire is being fire resistance of elements of building depleted of air supply. construction and standards using other methods to estimate the fire resistance are being developed in ISO/TC 92/SC 2, Fire containment. The basic standard ISO “ Measures to reduce 834, which is published under the general fires through title Fire resistance tests – Elements of Flashover of a living room. building construction, is used as a basis standardization globally for building regulations in many coun- are a very good tries. Of particular interest is the work investment in life on calculation methods for temperature development in fire-exposed structures, Fires in buildings cause the majority and property safety. ” of the fire casualties.

Standards for such parameters as ignitability, flame spread, heat release rate and smoke production are developed in ISO/TC 92/SC 1, Fire initiation and growth, and are used for the evaluation of performance of materials during the initiation and growth stage of a fire. Good examples of these ISO standards are the cone calorimeter method and the room corner test, which are used worldwide for hazard assessment in prescriptive regulations and fire safety engineering.

Fire resistance assessment of glazing in a fire test furnace. and the work on furnace control. The lat- ter will increase reproducibility of test data around the world – a very important factor in supporting free trade.

Toxic gases Smoke travelling throughout a building is the greatest threat to inhabit- ants’ lives and their chances for escape. The generation of smoke and its toxic The cone calorimeter measures effects are fundamental parameters for fire properties that can be used safety. Work in this area is conducted for prediction of fire growth. under ISO/TC 92/SC 3, Fire threat to

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Main Focus

Predictions of smoke propagation in support of fire safety engineering and fire investigations.

people and the environment. The standards developed by SC 3 provide the basis for including the harmful effects of fire effluent in fire hazard and risk assess- Imagine this smoke was escaping from a small room in an airport. ment. The hazard of toxic fire gases is Where does it go ? How toxic is it ? a growing concern, and SC 3 is working to address the current lack of scientific studies and technology to handle these questions. growth, using a reasonable design fire ment. Of particular interest is the work is another issue. Fire safety engineering on design fires and the use of test data Fire calculations holistically considers all relevant aspects for fire safety engineering. SC 4 docu- of the fire hazard of a building, and then ments are particularly useful, as regula- The calculation of smoke move- takes measures to reduce vulnerabili- tions in many countries allow perform- ment in a building and the consequences ties. ISO/TC 92/SC 4, Fire safety engi- ance-based design. for escape are typical challenges for fire neering, develops documents to support safety engineers. An estimate of the fire performance-based design and assess- No universal standard Many test standards address only About the authors a specific fire situation. If the real-life situation is different, the standard may Dr. Björn Magdalena Di be useless or even counterproductive. In Sundström is Carlo is a Pro- prescriptive regulations it is therefore Chair of ISO/TC gramme Manag- very important that the scope of a stand- 92, Fire safety. er at British ard is not extended out of the “ measur- He is the deputy Standards Insti- ing range ”. The same is true for calcu- head of the tution, Interna- lation methods. Department of tional Secretari- Fire Technology ats. She has 15 at SP, the Tech- years of experi- Work ahead nical Research ence running The European Commission recent- Institute of Swe- fire-related den and Professor in fire technology at committees at national, European and ly decided to propose self-extinguishing the Luleå University of Technology. Dr. international levels and is currently the cigarettes to be introduced in Europe fol- Sundström has developed major parts of Secretary of ISO/TC 92, Fire safety, and lowing their introduction in the USA. The the evaluation system for construction ISO/TC 92/SC 1, Fire initiation and standard will be developed in ISO/TC products’ reaction to fire under the Euro- growth, as well as CEN/TC 72, Fire 92 together with ISO/TC 126, Tobacco pean Construction Products Directive. He detection and fire alarm systems, CEN/ and tobacco products, and is based on received the Interflam trophy 1996 for TC 191, Fixed fire fighting systems, and the original ASTM standard. This project the technical leadership of the EU CEN/TC 191/SC 1, Smoke and heat con- is a good example of international coop- project, Combustion Behaviour of Uphol- trol systems and components. eration between ISO, industry and oth- stered Furniture (CBUF). er standardization bodies. It will likely E-mail : [email protected] save lives.

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teams, as well as by intervention forces in the case of terrorist attack. The standard has been developed because there is a need to harmonize on an international scale a system of communicating escape routes in facilities that relies as little as possible on the use of words to get the message through. With an increasingly mobile world population and ever-greater opportunities for international trade, graphical symbols are an essential tool for concisely conveying messages to users independent- ly of language. Where safety signs are concerned, ease and speed of recognition are vital to help save people from injury and death. ISO 23601 is based on the safety signs, colour codes and design requirements of ISO 7010:2003, Graphical symbols – Safety colours and safety signs – Safety signs. It establishes a common method of illustrating the position of the viewer in relation to designated escape routes leading to emergency exits and the location of fire safety and emergency equipment close to escape routes. It covers the following : • Design requirements • Size of plan elements • Content and representation • Materials • Installation and location • Inspection and revision. Continued growth in international trade, travel and mobility of labour requires a common method of conveying ISO standard for building this important safety information to the occupants of facilities. The use of ISO escape and evacuation plans 23601:2009 is expected to reduce risk by providing a means of improved training and education and to reduce possible confusion in times of emergency. by Sandrine Tranchard, signs, establishes design principles for ISO 23601:2009 was developed Communication Officer, displayed escape plans that provide information vital to fire safety, escape, by ISO technical committee ISO/TC 145, ISO Central Secretariat evacuation and rescue of a facility’s Graphical symbols, subcommittee SC 2, occupants. Safety identification, signs, shapes, sym- new ISO standard will help to bols and colours. The purpose of escape plans is to ensure that when fire breaks out help people orient themselves in relation in a building, occupants trying A to the planned escape route. In this way, to evacuate the premises are not left the escape plan complements the facili- scratching their heads trying to under- ty’s safety exit guidance system. These stand escape plans and signs. plans, which may be displayed as signs ISO 23601:2009, Safety identi- in work places and in public areas, may fication – Escape and evacuation plan also be used by fire, rescue and medical

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Main Focus

Faster and safer interventions by emergency vehicles

by Sandrine Tranchard, Communication Officer, ISO Central Secretariat

new ISO standard will help to ensure that police cars, fire engines A and other emergency vehicles will arrive at the emergencies to which they have been dispatched as quickly and safely as possible. ISO 22951:2009, Data dictionary and message sets for preemption and prioritization signal systems for emergency and public transport vehicles (PRESTO), standardizes messages in preemption signal systems for emergency and public transport vehicles. By • A roadside communication unit and Standard is indispensable. ISO 22951 providing a common infrastructure, the other roadside units includes examples of PRESTO at work standard aims to promote the dissemi- in different countries. ” nation of such systems. • In-vehicle units and roadside units. ISO 22951:2009, Data dictionary The benefits offered by implement- Preemption signal systems con- and message sets for preemption and pri- ing ISO 22951 include the following : trol traffic signals – for example, by oritization signal systems for emergency prolonging green lights, or shortening • Reduction in the response time of and public transport vehicles (PRESTO), red lights – on the basis of information emergency vehicles was developed by ISO/TC 204, Intelli- on the location of emergency vehicles, • Early resolution of accidents and gent transport systems, working group their speed, destination and direction of improvement of arrest rates (in the WG 8, Public transport/emergency. travel at an intersection so that emer- case of police interventions at crime gency vehicles can cross an intersection scenes) quickly and safely. At the same time, information on the passage of emergen- • Support for speedy rescue activity and cy vehicles can be transmitted to oth- improvement of lifesaving rates er vehicles and pedestrians in order to • Reduction of the number of traffic avoid collisions. accidents associated with en-route ISO 22951 thus addresses systems emergency vehicles that use priority signal control functions • Improvement public transport servic- to help emergency vehicles operate. This es by minimizing disruption. type of system comprises a traffic man- Mr. Koorosh Olyai, Convenor agement centre, in-vehicle units, road- of the ISO working group that devel- side communication units, and roadside oped ISO 22951, comments : “ When units. Public transport vehicles such as emergency or public transport vehicles buses may also be connected to priority cross borders, the potential for road safe- signal controls. ty hazards and public transport delays The scope of standardization become even greater. In order to avoid includes message sets and a data dictionary such situations and make it possible to related to communications between : use a common infrastructure for all emer- • A roadside communication unit and gency vehicles regardless of the coun- each in-vehicle unit try where they operate, an International

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Transparency and accountabili- Structural ty are essential to achieving appropri- safety against ate levels of safety for structures. ISO Mid-story collapse in Kobe, Japan suggests standards for actions and loads are impor- natural hazards the importance of vertical balance of tant in providing rational procedures for strength distribution. determining the design loads for structures. Probabilistic assessments of load intensity – such as maximum peak ground by Jun Kanda, Chair, ISO/TC Load intensity varies acceleration, maximum wind speed and 98, Bases for design of Under ISO technical committee maximum snow depth – are commonly structures, SC 3, Loads, forces ISO/TC 98, Basis for design of structures, described in ISO standards. and other actions subcommittee SC 1 handles terminolo- ISO 3010, Seismic actions on gy, SC 2 reliability of structures and SC structures, was first published in 1988 n many countries, the structural safety 3 actions and loads. When the technical and revised in 2001. In countries where of buildings is controlled by nation- committee revises or drafts new stand- seismic activity is low, structural design Ial regulations which specify mini- ards, their consistency with ISO 2394 is does not explicitly consider seismic safe- mum requirements. Most of these regu- always considered. The committee also ty. The seismic action is regarded as an lations have even longer histories than undertakes frequent reviews of Inter- accidental action. In countries with mod- ISO standards on structural engineer- national Standards for seismic actions, erate or high seismic activities, seismic ing. Safety is not simply derived from strong winds and heavy snows. action is regarded as a variable action engineering theories and data – cultural like wind or snow. The maximum seis- background and social experience also mic intensity during service lifetime is strongly influence regulatory specifica- treated as a probabilistic variable, and tions. This makes it difficult to direct- “ Transparency and the design seismic load intensity can be ly compare degrees of safety for build- determined either by the return period ings and other civil structures in vari- accountability are essential (the average recurrence interval over an ous countries. to achieving appropriate extended period of time or the inverse of ISO 2394:1998, General princi- levels of safety for the annual probability of exceedance) or ples on reliability of structures, is the structures. ” the reliability index. The differentiation basic structural engineering document. of safety demands should depend on the In many countries, structural engineer- consequences of failure as well as eco- ing practices have shifted from allow- nomic considerations, as indicated in ISO able stress design to limit-state design, Although uncertainties exist 2394:1998, General principles on relia- which is developed based on the reliabil- regarding both actions and structures, bility for structures. ity theory. If principles provided in ISO load intensity generally varies much 2394 are adopted for the development of more from environmental factors that Modelling static forces national codes, the structural safety con- cannot be controlled. The strength of cept can be commonly understood or har- a structure, however, can be accurately The seismic load is a dynam- monized in different countries. evaluated and improved by engineering ic factor, and the standard places con- advances. It follows that the design load siderable emphasis on modelling the determination significantly contributes equivalent static force distribution. The to the safety of structures. frequency-dependent spectral forms of Collapsed old timber houses in Kobe, Japan response and the vertical distribution of highlight the importance of maintenance. story shear forces are provided as general expressions in the standard. The interaction between a structure and the soil complicates evaluation of seismic loads, particularly for structures in the ground such as the founda- tions or tunnels. ISO 23469:2005, Bases for design of structures – Seismic actions for designing geotechnical works, provides a basic procedure for assessing seismic loads in such situations. Numerical examples have been discussed recently and will be published as a technical report for further information regarding practical application of ISO 23469.

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Main Focus

Role of ISO standards At the time you moved in, you Earthquake were proud of your new house. Space ISO standards on structural design was adequate for your needs, applianc- are generally developed as a standard for design – Why es worked properly, all materials con- code writers. National standard bodies firmed their good quality and you veri- or governments are therefore expected do we still need fied that energy consumption was admi- to make their standards and regulations experimental rably low. After few years, you were still consistent with relevant ISO standards. satisfied : no problems, not even a single However, the incentive is generally weak- confirmation ? crack in a partition. er in comparison to industries’ acceptance of ISO standards for their products. Then an earthquake struck. You In considering structural design versus were aware that your house was in a highly natural hazards, common understanding by Paolo Negro, EU-liaison seismic zone, but you had been told that among professionals representing their member, ISO/TC 71,Concrete, seismic design rules were strictly applied. national bodies can be expected in work- The shock was a strong one, close to the reinforced concrete and pre- maximum that could be expected in the ing groups. Discussions in TCs and SCs stressed concrete also contribute to the international har- area in one thousand years. Some old houses collapsed. monization of codes. Seismic standards have existed The development of ISO stand- since the early 20th century, so one might ards represents the empirical evolution of expect that knowledge about the seis- Designing for damage codes in societies around the globe. Fair mic behaviour of structures is now fair- trade of professional services in provid- ly accurate. The drafting and calibration What happened to your house ? ing safe structures for sustainable socie- of new standards – or the harmonization Although it didn’t collapse, it suffered ties is possible only when there is com- of existing ones – may still require sub- so much damage that you are now won- mon understanding among profession- stantial discussion, but it might come as dering whether it makes more sense to als. International Standards developed a surprise to learn that that there still is repair it or to re-build it. What went by ISO/TC 98 play a significant role in a need for experiments. wrong ? this context. Regrettably, existing numerical In all likelihood, nothing did. Peo- models still fail in accurately predict- ple may find it difficult to accept that a ing the seismic behaviour of structures. structure is designed to suffer significant Moreover, it is not yet possible to use damage in a strong earthquake, but this is such models for design purposes. As a the case for most non-essential facilities. result, any design norm – and the design Structures designed to withstand seismic process itself – is based on a combina- activity without damage would need to tion of common practice and simpli- remain elastic during the earthquake, and fied rules. These need to be calibrat- this would cause the building’s contents About the author ed against advanced numerical simula- (including people) to experience extremes tions, which in turn require experimen- of horizontal acceleration. Dr. Jun Kanda tal verification. is Chair of sub- Since there is no good way to committee SC Imagine that you own a recent- completely prevent structural damage 3, Loads, forces ly built house. Qualified professionals from a strong earthquake, designers and other took care of the design, following the work to limit the consequences. Indeed, actions, of ISO/ latest standards. Building materials are a certain amount of damage can be seen TC 98, Basis of of good quality, and inspection proce- as a means to protect the structure from design of struc- dures were strictly enforced. collapse. tures. He is a professor at the University of Tokyo, Graduate School of Frontier Sci- The ELSA ences. He specializes in structural engi- laboratory of neering, especially in structural safety, the Joint wind engineering and earthquake engi- Research neering. Centre.

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Designing for damage means on widely accepted principles rather than ensuring development of the proper dam- on current practice, as in the case of ISO age mechanism. For instance, a building international standards. will be safer if damage takes place in the beams rather that in the columns (weak Reinforced concrete building beams, strong columns). It is of course being tested at ELSA. Future needs preferable if the level of damage for the It is not acceptable for standards strongest earthquake is not beyond repair, to limit the adoption of innovative meth- and absent or minor for earthquakes of Testing the entire ods and techniques. In seismic design, smaller return periods. process limitations might arise from the prescrip- In most cases, no real design for In most cases, the behaviour of a tive parts of the standards : the effort to damage is actually carried out. Design structure in an earthquake does not sim- explicitly formulate performance require- is based on the application of simplified ply arise from the combined behaviour ments rather than impose rules and lim- procedures, which are intended to result in of its structural elements, because their itations might eventually result in ful- adequate behaviour (that is, the intended interaction is complex and the structur- ly performance-based standards. This damage levels correspond to the assumed al response is dictated by the behaviour is directly relevant to the mandate of intensity thresholds). Responsibility for of the structure as a whole. As a conse- ISO technical committee ISO/TC 71, the calibration of simplified procedures quence, experimental activities must be Concrete, reinforced concrete and pre- remains with the code drafters. performed on entire structures, or at least stressed concrete, subcommittee SC 4, on significant portions of them. Performance requirements for structural concrete. “ Existing numerical models On the other hand, civil engineering structures cannot be idealised. A Better understanding of struc- still fail in accurately structure is made of real materials with tural behaviour might change the over- predicting the seismic non-homogeneous mechanical proper- all philosophy of the standards. Where- behaviour of structures. ” ties. It generally complies with stand- as seismic actions are currently defined ard tolerances, possesses certain accept- in terms of forces, there is an increas- able defects in construction, and cannot ing awareness of the fact that deforma- tions, not forces, ultimately lead struc- The definition and calibration of be realistically reproduced on a smaller scale for testing. tures to collapse. A general consensus a design rule requires substantial effort, is emerging in regard to displacement- which is typically shared by the entire For these reasons, it is difficult to based design methods. earthquake engineering community. This test a typical civil engineering structure involves the development of adequate (such as a multi-storey building) to deter- The struggle to conceive more nonlinear numerical models, their cal- mine its behaviour during a significant advanced standards should go hand in ibration against experimental results, seismic event. Because shaking tables hand with the adoption of simplified their extensive use in parametric analy- typically suffer from severe payload lim- standards, for instance for the seismic ses, and possibly the execution of dem- itations, the “ pseudodynamic ” method assessment and rehabilitation of existing onstration tests. is more commonly used. This procedure buildings. Surprisingly, consensus regard- makes it possible to simulate the dynam- ing the format for simplified standards is ic response of a complex structure in an difficult to achieve, and there is a need for experimental data about the seismic About the author expanded time frame, taking advantage of associated advantages such as relief behaviour of structures designed according to old code. This area may offer the Paolo Negro is a from limitations in weight, cost, elec- greatest benefits from interaction between research officer tric power and the ability to accurately large structural engineering laboratories at the Joint measure any event. and code-drafting bodies, and ISO/TC Research Centre The European Laboratory for 71/SC 5, Simplified design standard for of the European Structural Assessment (ELSA) – a unit Commission. A concrete structures, is expected to play of the Joint Research Centre of the Euro- a leading role. graduate of the pean Commission – operates the largest University of pseudodynamic testing facility in Europe. California at The ELSA has pioneered development Berkeley and the of the method, and provides the neces- University of sary experimental results to the scientific Wales at Swansea, he has been doing community and standards-drafting bod- research in the field of structural and earthquake engineering since the opening of the ies such as the European Committee for European Laboratory for Structural Assess- Standardization (CEN) and ISO. ment at Ispra, Italy. Paolo Negro serves as This interaction is most needed EU-liaison member in ISO/TC 71. when standards are expected to be based

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Main Focus

Rubber structural mounts save lives during earthquakes

by Prof. Toshio Nishi, Convenor, ISO/TC 45/SC 4/WG 9, Elastomeric isolators, Dr. James M. Kelly, Professor of Civil Engineering, University of California at Berkeley, and Prof. Fu Lin Zhou, Vice-President, Anti-Seismic Systems International Society 1)

In the late 15th century, Christo- pher Columbus saw people on the island of Hispaniola playing with a strange bouncing ball made of a gum gathered from a tree. The material was later named “ rubber ” as it could be used to rub away pencil marks. Since the development of vulcanization in the United States by Charles Goodyear in the middle of the 19th century, rubber has steadily established its position as an important industrial material used in many vital prod- On 12 May 2008, an earthquake hit the province of Sichuan, China, which caused heavy damage ucts such as tires, hoses, shoes, gloves, to a school in Yingxiu (above). The earthquake resulted in some 70 000 fatalities. and fluid-seals. Now a new application of rub- as the structure itself. The capability to Alternating layers ber has been introduced : “ Elastomeric extend protection to the contents is par- Elastomeric isolators, installed seismic-protection isolators ”, or simply ticularly vital in buildings such as hos- between the superstructure and its base “ Elastomeric isolators ”. These isolators pitals and emergency control centres (Figure 1), protect buildings or bridges are capable of supporting buildings and that must remain fully operational after by decoupling the structure from hori- other structures such as bridges, pro- an earthquake. viding protection from damage during zontal ground motion. Elastomeric bear- earthquakes. The service life of the iso- ings, the most common type of base isolators is anticipated to be at least sever- Figure 1 – Principle of base isolation. al decades. Compared with conventional methods that rely on making the struc- Fixed-base Base-isolated ture strong, this technique of earthquake protection has the advantage of protecting the occupants and contents as well

1) The authors thank Dr. Nobuo Murota (project leader of ISO/TC 45/SC 4/WG 9) and Dr. Keith Fuller (UK representative to ISO/TC 45/SC 4/WG 9) for their valuable contribution to this article, as well as for their key role in the development of the ISO 22762 Deformation of standard. isolator

26 ISO Focus June 2009 © ISO Focus, www.iso.org/isofocus

Bolt hole Inner rubber A. Rubber block B. Laminated rubber bearing Stiffness Reinforcing plate Comp. of B Cover rubber Comp. of A Flange

Figure 2 – Schematic view Shear of A and B of elastomeric isolator.

Compressive stiffness : B >> A lation device, consist of alternating lay- Shear stiffness : ers of rubber and thin steel plates firm- B = A ly bonded to each other (Figure 2). The steel plate reinforcement provides a high Figure 3 – Principle of laminated rubber bearing. compressive stiffness to reduce vertical deflection under the heavy weight of the structure, making the isolator stable. The large shear deformation capacity need- base isolation and elastomeric isolators. rubber layers provide the very low hori- ed. The principle of the laminated bear- In the Northridge, California earthquake zontal stiffness needed to give the struc- ing is shown in Figure 3. of 1994 and the Kobe, Japan earthquake ture a horizontal natural frequency (typ- Elastomeric isolators were first used of 1995, buildings on elastomeric isola- ically 0.5 Hz) lower than the peak fre- in construction of an elementary school in tors were subjected to significant ground quencies of an earthquake. This decou- Skopje, Macedonia, in 1969. However, these shaking. Data from acceleration-measur- ples the structure from ground shaking, isolators had no steel reinforcing plates ing instruments installed in the structures reducing the transmission of earthquake and so were soft in the vertical direction. confirmed that they performed accord- forces into the structure and protecting Since then, laminated rubber-steel elasto- ing to expectations and that the forc- both the structure and its contents. meric isolators have been used. es transmitted into the buildings were greatly reduced. The California build- During a large earthquake, a shear An extensive research and devel- ing, a hospital, remained operational, (horizontal) displacement of several hun- opment effort in several countries using unlike conventionally built structures dred millimetres may be imposed on the both analytical tools and shaking-table in the area. isolators. The rubber layers provide the tests has helped prove the efficacy of

About the authors

Prof. Toshio James M. Kelly Professor Fu Nishi has been is Professor of Lin Zhou is a Convenor of Civil Engineer- member of the ISO/TC 45/SC ing at the Uni- Chinese Acade- 4/WG 9, Elasto- versity of Cali- my of Engineer- meric Isolators, fornia at Berke- ing. He is Pro- since 2000. He ley. In recent fessor and was President of years he has Director of the the Society of been primarily Earthquake Rubber Indus- concerned with Engineering try, Japan from seismic response Research & Test 1995 to 1997 and Vice-president of the of structures and new methods of seismic- Center (EERTC) of Guangzhou Univer- Society of Polymer Science, Japan, from resistant design. Professor Kelly has been sity, China, and Chairman of the Chi- 2000 to 2002. He is currently Professor the leading proponent in the United States nese Committee on Seismic Isolation, at WPI Advanced Institute for Materials of using multilayer elastomeric bearings Energy Dissipation and Control of Research, Tohoku University in Sendai, for seismic protection of buildings. In Structures of ASC China. He is also Japan, and Emeritus Professor of the 1996, he published the second edition of Vice-President of the Anti-Seismic Sys- Tokyo Institute of Technology and the his book based on his many years of tems International Society (ASSISi). University of Tokyo. research and testing at EERC (Earth- quake-Resistant Design with Rubber, 2nd ed. Springer-Verlag), which applies this research for the design of base isolation systems using natural rubber isolators.

Main Focus

apartment blocks of brick wall construction, located in southern Ganshu Prov- ince 200 km from the earthquake’s epi- centre, were well protected ; equipment and furniture inside the building were also undamaged (Figure 5). On the other hand, a fixed-base building in the same area had significant damage to both the structure and the equipment inside. Figure 6 – An example of a testing machine ISO/TC 45/SC 4/WG 9, Elastomeric for elastomeric isolators. Figure 4 – 2008 Sichuan earthquake. isolators, began working in 2000 to develop standards covering testing methods and ticing structural and mechanical engi- product specifications for elastomeric iso- neers, and polymer scientists and rub- Protection confirmed lators. The first edition was completed and ber manufacturers. Base isolation technology has issued in July 2005 as ISO 22762, Elas- Base isolation technology has gained great popularity worldwide in the tomeric seismic-protection isolators. The developed very rapidly in the last ten past decade as an effective means for seis- standard consists of three parts : years, with steady release of new appli- mic protection of structures such as office • Part 1 : Test methods cations, devices and systems. In Japan, buildings, hospitals, museums, historical large warehouses and high-tech plants, buildings, highway and railway bridges, • Part 2 : Application for bridges – Specifications similar to those for semi-conductor fab- and storage tanks. In Japan, more than rication, have been considered as new 2 000 base-isolated buildings, many of • Part 3 : Application for buildings – application fields; in these cases, base iso- them apartment blocks, have been con- Specifications. lation would secure business continuity. structed or are under construction since The three parts together total more The application to high-rise buildings is the Kobe earthquake. than 220 pages. also becoming popular, but requires very Further confirmation of the effec- large isolators. Isolators of up to 1 600 tiveness of base isolation was provided in mm diameter and around 600 mm height the 2004 Chuetsu earthquake of Japan’s are currently available, a size capable of Niigata Prefecture. Instrument records “ Elastomeric isolators sustaining over 20 MN axial load and from the Hokuriku Gakuen College, protect buildings or 800 mm shear displacement. mounted on 17 high-dampening rubber bridges by decoupling To keep abreast of new devel- isolators, indicated that the acceleration opments, ISO/TC 45/SC 4/WG 9 start- at the first floor, just above the isola- the structure from ed revision of ISO 22762 in 2006, just tion system, was reduced to 50 % of the horizontal ground motion. ” after the first version was issued. The ground acceleration. revised version is scheduled to be issued In China, some 690 buildings in 2010. are base-isolated, and those affected by The composition of ISO/TC 45/SC the 2008 Sichuan earthquake (Figure 4) 4/WG 9 is unique. Participants include again verified the efficacy of this tech- researchers with backgrounds from earth- nology. Three base-isolated, six-storey quake and structural engineering, prac-

Figure 5 – Base-isolated apartment Figure 7 – Compression/shear testing of an elastomeric isolator. building in Sichuan.

Billions at stake A number of standards are being developed for information security within ISO/IEC JTC 1/SC 27. In particular, the working groups WG 1 and WG 4 are developing standards relating to information security management for application across a diverse set of industries such as telecom, healthcare, energy supply, finance, insurance and supply chain. These industries are often critical elements of national infrastructure.

“ ISO/IEC JTC 1/SC 27 is developing standards for industries that are often critical elements of national infrastructure. ”

Several examples over the last 18 years demonstrate that if the information security of these essential industries is compromised, society is placed at risk. In the 1980s and 1990s, the United Kingdom – in particular London – suffered many such infrastructure attacks, all of which were intentionally initiated. And in recent years, natural disasters such as the South- east Asian tsunami and earthquakes in Japan and China also caused significant impacts on human safety and the avail- ability of information systems. Today’s risks can, in worst case Information security – scenarios, lead to complete shutdown of businesses, property damage running Risks or hazards into millions if not billions of dollars, disruption of critical services and infrastructure, and loss of life. by Prof. Edward Humphreys, originates from exposure to something Convenor, ISO/IEC JTC 1/SC which may result in personal injury or death, the loss of information, damage Network security 27/WG 1, Requirements, to property and so on. It is clear that IT systems them- security services and guidelines, Safety and security often occupy selves are not always the problem; the larg- and Convenor, the same space. For example, the securi- er threat is often from people, including Dr. Meng Chow Kang, ty of the data in a patient’s health record external users such as visitors, customers ISO/IEC JTC 1/SC 27/WG 4, system may have an impact on the health and partners, and the growing problem Security controls and services and safety of the patient. Or the security of insider threats from employees. of the data in a system used for air traf- The information standards being hile the safety world tends fic control may have an impact on the developed in ISO/IEC/JTC 1/SC 27/WG to discuss hazards, we in the ability of air traffic controllers to main- 1 and WG 4 are based on the assumption Winformation security world tain safety. that an organization applying these stand- are more likely to talk about risks. In ards carries out a proper risk assessment both areas, some argue that their domain to address the problems raised above.

Managing information Msecurityain Focus by Sandrine Tranchard, Communication Officer, SC 27/WG 4 has published stand- embarked on new standards projects relat- ISO Central Secretariat ards addressing the provision of disaster ing to the security of outsourcing (ISO/ With more and more recovery services (ISO/IEC 24762), net- IEC 27036) and the management of dig- work security (ISO/IEC 18028), intrusion ital evidence (ISO/IEC 27037). organizations implementing detection systems (ISO/IEC 18043), and information security SC 27/WG 1 has published ISO/ information security incident manage- IEC 27001 to address the establishment, management systems ment (ISO/IEC TR 18044). While some implementation, monitoring and review (ISMS) as part of their risk of these standards are under revi- of information security management strategy, the sion, WG 4 is also develop- management sys- publication of a new ISO/IEC ing standards on cyberse- tems (ISMS). The standard giving an overview of curity (ISO/IEC 27032) ISMS is appli- ISMS is particularly timely. in collaboration with cable to all siz- ITU-T. The security es and types of ISO/IEC 27000:2009, of networks and ICT organizations Information technology devices is now crucial from small to – Security techniques to the safety of societies very large and – Information security around the world. from low- to high- management systems – tech. SC 27/WG 1 has Overview and vocabulary, produced and published a Business continuity standard on ISMS risk management as will assist organizations of WG 4 is also producing a stand- well as the accreditation of an organiza- all types to understand the ard to address ICT readiness for busi- tion’s ISMS implementation. In addition, fundamentals, principles and ness continuity (ISO/IEC 27031), and the they have jointly produced and published, concepts to improve protection working group is collaborating with other with ITU-T, telecoms security require- of their information assets. committees to develop business continu- ments on security controls in support of ISMS implementations. Applicable to all types and ity standards. In 2009, WG 4 has further sizes of organization (e.g. commercial enterprises, government agencies, non- profit organizations), ISO/IEC 27000:2009 supplements About the authors the ISO/IEC 27000 family of Prof. Edward Dr. Meng standards by providing an Humphreys Chow Kang is introduction to information (ISMS Research Director of security management and Professor Korea Information defining related terms. University) has Security for been leading the China and APJ Today, an organization’s United King- regions (Asia- information assets are dom’s activities Pacific and dependent upon information regarding the Japan) for Cisco and communications ISO/IEC 27000 Systems, Inc. family of infor- He has been a technology. The technology mation security management system practicing information security profes- assists in facilitating the (ISMS) standards and the British stand- sional for more than 20 years, with field creation, processing, storing, ards BS7799 Parts 1 and 2 (which experience spanning from technical to transmitting, protection and formed the basis for ISO/IEC 27001 and management in the various security and destruction of information. ISO/IEC 27002) since 1990. He is also risk management roles in the Singapore responsible for many of the ISMS government, major multi-national finan- As the extent of the accreditation and certification activities cial institutions, and security and tech- interconnected global business as well as producing the standard EA nology providers. Dr. Kang has been environment expands, so does 7/03. He is an ISMS consultant provid- contributing to the development and the requirement to protect ing advice to organizations around the adoption of international standards relat- world. He is also founder and Director ing to information security since 1998, information as it is exposed to of the ISMS International User Group, and is the founder of the Regional Asia a wider variety of threats and which promotes the global use of the Information Security Standards (RAISS) vulnerabilities. ISO/IEC 27000 family for ISMS stand- Forum. He is currently Convenor of ards. ISO/IEC JTC 1/SC 27/WG 4, Security controls and services.

The evolving nature of risks Other application- and sector- specific guidelines and standards are being developed to support ISMS implementations, for example regarding information security governance and the protection of critical national infrastructure. These standards are aimed at Preventing theft and unauthorized modification addressing the threats and impacts that of electronic data organizations face today. Of course threats and risks change constantly, increasing in by Maria Lazarte, complexity as more information systems Assistant Editor, ISO Focus become interconnected to exchange and share information. ISO/IEC JTC 1/SC 27 To protect the confidentiality and integrity of data being transferred continuously monitors the future risk or stored, ISO and IEC have jointly developed a new standard which landscape, aiming to build preventive defines authenticated encryption mechanisms that provide an optimum security measures that help organiza- level of security. tions manage the risks emerging with business growth while at the same time “ With the rise of electronic transactions involving sensitive information, increasing use of more advanced infor- such as the transfer of bank data or personal identity information, mation technology systems. this standard responds to a growing need for increasingly demanding security requirements. ” says Prof. Chris Mitchell, Project Editor of the new ISO/IEC standard. “ Threats change The standard, ISO/IEC 19772:2009, Information technology – Security constantly, increasing techniques – Authenticated encryption, specifies six encryption methods in complexity as more (based on a block cipher algorithm) that can be used to ensure : information systems • Data confidentiality (protecting against unauthorized disclosure of data) become interconnected to exchange and share • Data integrity (enabling recipients to verify that the data has not been modified) information. ” • Data origin authentication (helping recipients to verify the identity of the data). Other subcommittees within JTC 1 Prof. Mitchell explains, “ It has recently become widely recognized that are also developing standards that have using encryption on its own (or even combining encryption and Message security as a sub-component, such as SC Authentication Codes in non-optimal ways) can be dangerously weak, as 37 on biometrics. Security standardiza- shown by recently demonstrated practical attacks on implementations tion work is, in most cases, conducted in collaboration with SC 27, a member of of widely used security protocols such as IPsec and SSH. There are the Joint Technical Collaboration Group thus excellent reasons to believe that it is better to rely on a single on management system standards, which comprehensive data protection method. ” includes those dealing with ISO 9001 for The mechanisms specified in the standard have been designed to quality, ISO 14001 for environment and ISO 22000 for food safety. maximize the level of security and provide efficient processing of data for optimum results. Despite sometimes overwhelming challenges, help is available to organi- The standard includes mechanisms that can be applied to ensure the zations through the toolbox of stand- integrity of data even when not encrypted (e.g. to prevent modifications ards published or under development by of e-mail addresses, sequence numbers, etc.). ISO/IEC JTC 1/SC 27. “ ISO/IEC 19772 will give confidence to users that their data is safe. Not only will it be useful for protecting information, but also for furthering the development of online transactions and e-businesses, and other applications involving sensitive data, ” concludes Prof. Mitchell.

transport has developed its own rules such it was a classic combination of essential Creating modern as the International Maritime Dangerous safety requirements and a listing of ISO Goods Code developed by the Internation- standards which detailed how these essential regulations for al Maritime Organization (IMO) and the requirements were to be met. In all, there the transport of Technical Instructions published by the were 17 standards from ISO/TC 58. International Civil Aviation Organization With the recent publication of dangerous goods (ICAO). Since goods often travel by more the 16th edition, the list of standards has than one mode, there is a clear need to increased to 27 to accommodate evolv- harmonize requirements, and this work ing technology of gas cylinders such as has been achieved by the United Nations by Dr. Chris Jubb, Chair of ISO/ composite construction (reinforcement by Economic and Social Council’s Sub-Com- fibre wrapping), welded cylinders of steel, TC 58, Gas cylinders, and Randy mittee of Experts on the Transport of Dan- stainless steel and aluminium alloy and Dey, Chair of ISO/TC 197, gerous Goods (UN/SCETDG). testing by means of acoustic emission. Hydrogen technologies The Sub-Committee has become the paramount instrument of global har- he world of international transport monization in the transport of danger- Highest possible quality has seen the need to guarantee safe- ous goods. Its recommendations, com- Each new proposal to accept an ty when carrying dangerous goods, T monly known as the “ Orange Book ”, ISO standard into the regulations is not such as gases in cylinders. Each mode of were first published in 1956, taken lightly. The UN/SCETDG experts th and are now in their 16 edi- (using their own specialists) examine the tion. The recommendations, standards to ensure their clarity, enforce- presented these days under ability and compatibility with the safety the heading, “ Recommen- principles of the dangerous goods regu- dations on the Transport of lations. It is therefore essential that ISO Dangerous Goods, Model standards are clear and constructed to fit Regulations ”, (or UN Mod- the structure of the regulations. This care el Regulations), provide a pays dividends and ISO/TC 58 has a good basic scheme of provisions record of having its standards accepted. for the uniform development of national and international regulations. Thus, the UN Model Regulations “ It is therefore are an excellent tool for writing rules for the transport of dangerous goods, essential that which apply to all international jour- ISO standards are neys, and can also be applied to nation- clear and constructed al journeys. to fit the structure of the regulations. ” Taking the lead ISO technical committee ISO/TC 58, Gas cylinders, consists of manufacturers and users of gas cylinders committed There will be more proposals to global harmonization. When the UN/ emerging from ISO/TC 58 as the com- SCETDG decided to create requirements mittee seeks to reflect the evolution of for gas cylinders in the late 1990s, ISO/ manufacturing and testing techniques TC 58 naturally became closely involved. in the development of its standards. For Its involvement served a two-pronged example, there are two proposals pending approach. On the one hand, the commit- for the committee’s next meeting. tee was able to influence national and Having been part of establishing international regulations and, on the oth- ISO as a valued participant in creating er hand, encourage the use international modern regulations for the transport of standards instead of national standards, dangerous goods, ISO/TC 58 is pleased thereby reducing barriers to trade. that new standards associated with the When the first recommendations emerging use of hydrogen, namely ISO on gas cylinders were published in 2001 16111:2008, are able to find a place in (12th edition of the UN Model Regulations), the regulations.

Hydrogen technologies Gas cylinders

ISO technical committee ISO technical committee ISO/TC 197 was created in ISO/TC 58 is responsible for 1990 to develop standards the standardization of gas in the field of systems and cylinders, their fittings and Throughout the development proc- devices for the production, characteristics relating to their ess, ISO/TC 197 ensured UN/SCETDG storage, transport, manufacture and use. was informed of the progress of ISO measurement and use of The secretariat of 16111. This information exchange, which hydrogen. ISO/TC 58 resides with the was supplemented with USFCC support, was pivotal in ensuring the stand- The secretariat of ISO/TC British Compressed Gases ard’s place in the UN Model Regulations 197 resides with the Bureau Association, which acts on shortly after its publication. de normalisation du Québec behalf of the British Standards ISO/TC 197 had to invest many (BNQ), which acts on behalf Institution (BSI) with Stephen resources to publish ISO 16111:2008 in of the Standards Council of Elliott as Secretary. the short timeframe that would allow its Canada (SCC) with Sylvie reference in the 16th edition of the Orange Gingras as Secretary. Book. In the end, the fruitful collaboration proved well worth the effort.

A success for hydrogen With the publication of ISO storage 16111:2008 and its subsequent uptake by the UN/SCETDG, these redundancies are Developed by ISO/TC 197, Hydro- no longer a concern. This success story, gen technologies, ISO 16111:2008 will which seems simple on paper, required help pave the way for larger, widespread a lot of work and coordination. applications of hydrogen. The Interna- tional Standard describes the service conditions, design criteria, type tests A cooperative spirit and routine tests for ensuring the safe- ISO 16111:2008 first appeared as ISO ty of metal hydride assemblies used for technical specification ISO/TS 16111:2005. the storage of hydrogen. A joint working group of ISO/TC 197/WG Until now, hydrogen stored in 10 and ISO/TC 58/SC 3, Gas cylinder design, metal hydride assemblies could not be had only 24 months to upgrade the docu- shipped or transported without special ment to the status of International Standard. permit allocated on case-by-case basis. All interested stakeholders, namely ISO/ This costly and lengthy process did not TC 197 and ISO/TC 58 experts, the regu- ensure consistency across internation- latory authorities, the industry association al borders. It was also seen as a barri- represented by the USA Fuel Cell Council er to the large-scale commercialization (USFCC), as well as the ISO Central Sec- of this convenient method of hydrogen retariat, had to work in a cooperative spirit storage. to make this happen.

About the authors

Dr. Chris Jubb Randy Dey is Industry benefits is the Chair of the Chair of The provisions of the UN Model ISO/TC 58, Gas ISO/TC 197, regulations applicable to hydrogen stored cylinders, and Hydrogen tech- in metal hydride assemblies will allow joined the nologies, and an shipment of hydrogen storage assemblies industrial gas expert in inter- certified as conforming to ISO 16111 to industry in national stand- become routine. The industry will no longer 1981. He has ards and codes need special permits allocated on a case- been actively development by-case basis and the hydrogen stored in engaged in the and compliance metal hydride assemblies will be able to development of with a special travel across international borders. international standards and legislation focus on hydrogen, fuel cell and alter- concerned with gas cylinders for the nate fuel sectors. He holds leadership The removal of this technical bar- past 17 years. He also chairs CEN/TC positions in several forums related to rier to trade, which is the result of a close 23, Transportable gas cylinders. hydrogen and fuel cell technologies and cooperation between ISO and the UN/ E-mail : [email protected] he is very active at the UN. Contact : SCETDG, represents a major benefit for Randy Dey, The CCS Global Group Inc. industry. It should certainly be consid- E-mail : [email protected] ered as a model for the future.

Developments and Initiatives

opment, ISO needs to innovate ISO President’s and to identify the best way to add value to the evolving visits highlight world framework.” “confidence” as The President drew attention to the current finan- key for tackling cial crisis and concerns about global challenges the environment. “These challenges are global in scale, and require global solutions. ISO Interna- ISO President Dr. Alan Morrison tional Standards, which dis- went on a tour of epic proportions to vis- till state-of-the-art experience ISO President with TSE’s management. it the ISO members for Ireland (National and knowledge from experts Standards Authority of Ireland), the Neth- around the world, can serve erlands (Nederlands Normalisatie-institu- as powerful solutions.” ut), Turkey (Türk Standardlari Enstitüsü) He also spoke on the and the USA (American National Stand- ability of ISO standards to ards Institute) in May 2009. ensure and instill confidence, The visits provided a valuable which he said, was particularly occasion for the President to meet with important in times of crisis. “ A the staff of all four organizations, their major casualty [of the econom- respective board of directors, and public ic recession] has been business authorities. “These visits underline the confidence, making imperative importance that ISO places in maintain- the need to restore confidence, ing close relations with its members,” to promote good business and said the President. governance practice, as well as Dr. Morrison spoke on the latest increasing the need for better developments in ISO and discussed the risk management and ensuring Alan Morrison (second from left) with ISO Strategic Plan 2011-2015, which, he business continuity. members of NEN’s supervisory board (from argued, should address emerging inter- The outlook for ISO has so far left : Kees van der Waaij, Jacques Schraven national priorities. been positive “Despite the crisis, the – Chairman, Michiel Boersma) and NEN’s “ISO’s proven track record, and ISO family has increased since the end Managing Director Jan Wesseldijk (far right). particularly its achievements under the of 2008 from 157 to 161 national mem- current Strategic Plan give it a solid bers, representing 98 % of the world foundation to address global challeng- economy and 97 % of its population, and said the President, and referred to the es,” explained Dr. Morrison. “However, our portfolio has now reached 18 000 new technical and project committees in order to continue its successful devel- standards.” launched on topical areas as diverse as “ISO has also experienced a surge solid biofuels, product recall and road- in activity over the last 15 months,” traffic management to name a few. ISO President (right) meets Ireland’s Minister for State and Commerce, Billy Kelleher.

From left : ANSI’s Chairman of the board Arthur E. Cote, ISO President Alan Morrison and ANSI’s President and CEO Joe Bhatia. © ISO Focus, www.iso.org/isofocus New on the shelf

• Energy efficiency ISO for CEOs • Social responsibility. Text is kept to the minimum, communicating by a maxi- by Roger Frost, Manager, mum of concrete examples, most of Communication Services, them expressed in financial terms. ISO/CS They show how ISO International Standards : SO has just launched a new commu- • Contribute to economic pros- nication package, specially devel- perity and growth oped to give top managers a concise I Provide benefits and cost sav- overview of the benefits to their organ- • izations of : ings across industries • Implementing ISO standards • Have a positive impact on the bottom line • Integrating international standardization with their strategies • Support innovation. • Participating through ISO’s nation- The contribution of ISO’s al members in the development of current portfolio of more than standards. 18 000 standards to the economic, environmental and societal Today’s state-of-the-art global dimensions of sustainable world solutions for CEOs consists of an attrac- is evoked, along with some of tive brochure and accompanying Power- ISO’s principal partners among Point presentation (both also available in more than 700 public and pri- French) which explain to busy managers vate sector organizations. the advantages of putting International Standards on the leadership agenda. The brochure ends with a call to to allow them to present action, encouraging CEOs to discover The brochure is designed to con- the communication package directly – more about the ISO system by contact- vey at a glance how ISO standards can preferably in person – to top managers ing their ISO national member body and provide solutions to typical challenges in the business and private sectors. ISO working with it to achieve the maximum faced by CEOs, such as : members can download the brochure of benefits. graphics and PowerPoint presentation • Innovation Today’s state-of-the-art glo- via the ISO Marketing & Communica- • Cost reduction bal solutions for CEOs is being sup- tion www.iso.org/marcom for transla- • Product safety plied by ISO to its national members tion and adaption, including by adding their logos and contact details. • Access to global markets • Risk management • Environmental impact • Quality management • Customer relationships

ISO International Standards

Sustainability ISO’s broad range of standards provides practical tools for addressing all three dimensions of sustainable development – economic, environmental and societal. International Climate change International Standards help to tackle climate change at four levels: Standards • Monitoring climate change • Quantifying greenhouse gas support the pursuit (GHG) emissions • Promoting good practice in of innovation energy management and design • Opening up world markets for energy-efficient technologies.

Radio Frequency Standards are increasingly crucial to Identification (RFID) innovative new working methods in global supply chains. A number of recent standards for RFID and intelligent transportation systems, facilitating freight movement and intermodal transport, will enable new technologies to be applied to enhance security and efficiency and thus foster innovative change.

Nanotechnologies The nanotechnology field is growing rapidly. International Standards in this area are focused on terminology, testing, modelling, science-based health, safety and environmental practice. These technologies are, for instance, applied to the new e-passport, using biometric facial imagery as its main security feature, which is recognized for its innovative use of standards.

Water supply Standardization of services related to the management of drinking water is a new field of work being tackled by ISO, which focuses on the management of provision of water, the preservation of water supply in crises and the efficiency of distribution networks.

Energy ISO standards are helping to facilitate the dissemination of innovative technologies and to structure markets for them in areas that include solar energy, nuclear energy, hydrogen technologies, and solid and liquid biofuels, as well as of technologies, metrics and good practice impacting on energy efficiency such as energy management systems, intelligent transport systems, the thermal performance of buildings, and the comparison of energy systems and energyware balances.

New on the shelf

Because wind is just one of the The objective of this International ISO standard to elements to be considered when design- Standard is to achieve a uniformly high ing structures, in addition to, for exam- competency of crane inspectors world- ensure structures ple, the weight of the structure, load of wide. In some countries, there may be are not “gone occupants or seismic actions, ISO 4354 is additional regulatory requirements that also intended as a bridge between exist- must also be taken into account. with the wind” ing ISO International Standards dealing Two other standards point out with the subject. that to ensure cranes are operated safe- This standard can therefore be used ly, their proper working and operation- by Maria Lazarte, in conjunction with ISO 2394, General al conditions need to be maintained. principles on reliability for structures, Therefore, all cranes require to under- Assistant Editor, ISO Focus as well as other ISO International Stand- go inspections to detect deviations from new International Standard, ISO ards on design of structures. safe conditions so they can be put right. 4354:2009, Wind actions on struc- ISO 4354, Wind actions on struc- The inspections are the responsibility of A tures, will help ensure the relia- tures, was prepared by the ISO technical crane users or owners. bility of structures in areas exposed to committee ISO/TC 98, Bases for design ISO 9927-1:2009, Cranes – strong winds and cyclones. of structures, subcommittee SC 3, Loads, Inspections – Part 1 : General, speci- The standard describes the actions forces and other actions. The standard fies the inspections to be carried out on of wind on structures, and specifies meth- is available from ISO national member cranes, excluding inspections carried out ods for calculating characteristic values institutes. It may also be obtained directly prior to first use. of wind loads. from the ISO Central Secretariat through ISO 9927-3:2005, Cranes – the ISO Store (www.iso.org/isostore) or “Perhaps one of the biggest advan- Inspections – Part 3 : Tower cranes, by contacting the Marketing & Commu- specifies the regular inspections to be tages of ISO 4354 is that it allows you to nication department ([email protected]). bridge the gaps of all wind loading codes carried out on tower cranes. around the world,” says Prof. William Cranes are used worldwide in the Melbourne, Convenor of the working construction, manufacturing and trans- group that developed the standard. portation industries wherever the safe ISO 4354:2009 cancels and replac- lifting and moving of loads is required. es the first edition of the standard, origi- The progressive introduction of new nally published in 1997, with a full tech- International Standards and the regular nical revision. Lifting the safety review of existing ones will have a direct and positive effect on general safety by The standard covers design meth- level of cranes reducing potential hazards, as well as odologies for three main storm types : syn- helping to remove technical barriers to optic winds (large scale winds), thunder- worldwide the international trade in cranes. storms and topical cyclones (hurricanes, typhoons). It provides the basic methods Actively involved in the elabora- for determining wind loading analytically tion of these standards are multi-nation- for simple structures and guidance for the by Sandrine Tranchard, al and national manufacturers, users, design of more complex structures. Communication Officer, ISO inspection bodies, institutions for higher education, insurance companies and ISO 4354 will be useful for struc- Central Secretariat government health and safety organiza- tural engineers involved in the design of tions from all five continents. buildings, towers, chimneys, bridges and There is always a potential dan- other structures, and their components ger involved in the operation of cranes. ISO 9927-1:2009, ISO 9927- and appendages. The standard will be of New ISO standards on crane inspections 3:2005 and ISO 23814:2009 were devel- particular interest for countries without aim to reduce the risk of accident both oped by ISO technical committee ISO/ an adequate wind loading standard. to persons involved in a lifting opera- TC 96, Cranes, subcommittee SC 5, Use, tion and those in the vicinity, as well as operation and maintenance. of damage to property. The standards are available from ISO 23814:2009, Cranes – Com- ISO national member institutes. They petency requirements for crane inspec- may also be obtained directly from the tors, specifies the competency required ISO Central Secretariat through the ISO of persons who carry out periodic, excep- Store (www.iso.org/isostore) or by con- tional, alteration and thorough inspec- tacting the Marketing & Communication tions of cranes. It excludes the day-to- department ([email protected]). day inspection and checks performed by crane operators and maintenance personnel.

Developments and Initiatives

COPOLCO workshop on interoperability “ Does it fit, will it work and can standards help ? ” was the subject of the workshop organized by the ISO Commit- tee on consumer policy (ISO/COPOLCO) in New Delhi, India, in May 2009. About 100 participants from consumer associations, public authorities, businesses and from the national standards bodies of some 30 countries came together to discuss how consensus-based International Standards can help meet consumer needs for interoperability of goods and services. Asking questions like “ Why can’t I install my new software properly ” or Main Focus “ Why do I need so many different remote control devices ”, the workshop looked at The financial crisis ISO standards also help compa- areas where lack of interoperability pos- nies to reduce costly research and devel- Overcoming the current economic es safety risks to consumers and restricts opment, and facilitate the introduction of recession is one of the world’s biggest their access to a full range of goods and new products into markets. Their imple- challenges. The July/August issue of ISO services, fair prices and information. mentation helps business to keep and win Focus looks at not only how International customers. Developing countries can apply Focusing on some of the conse- Standards can contribute to recovery, but International Standards to increase their quences of a lack of interoperability (includ- also to establishing solid economic foun- global competitiveness in difficult times. ing for con- dations for preventing future crises. And ISO standards like the future ISO sumer access Studies conducted in various coun- 31000 on risk management can be used to knowledge tries have shown the economic benefits by organizations to prepare and respond and informa- of standards. In the United Kingdom efficiently to crises. tion, and safe- alone, the macro-economic benefit has ty risks linked Finally, by helping companies been quantified at an annual contribu- to counterfeit- improve their sustainability perform- tion of GBP 2.5 billion to the national ing), the work- ance, ISO standards not only contribute gross domestic product. shop looked at to safeguarding the future, and its eco- how Interna- In times of crisis this contribution nomic integrity, but also helping com- tional Stand- is even more salient. ISO 9001 (quality panies reputation in a time where ethics ards can help management) and ISO 14001 (environ- and responsibility are increasingly nec- achieve con- mental management) are well-known essary to attract customers, target regu- sumer expec- tools recognized for helping business to lation and encourage businesses. tations in streamline their operations and improve COPOLCO - program workshop Indi In the next issue of ISO Focusa 2009.indd 1-2 we terms of efficiency, while saving costs. But, perhaps look at some of the tools that ISO has cost savings, 13.05.2009 12:05:56 more importantly, ISO standards serve to to offer including standards for training longer product life, greater convenience instill confidence, one of the major cas- financial planners, promoting customer and reduced waste. ualties of the financial crisis. satisfaction and providing confidence in Presenters also addressed the chal- Restoring confidence, whether in financial service institutions. lenges posed by market barriers and intel- business to business transactions, among Learn all about the latest devel- lectual property, which can contribute to the consumers, clients or stockholders, is cru- opments on standards for targeting coun- proliferation of incompatible models. cial to recovery. And this can be achieved terfeiting, fighting fraud, and ensuring by conforming to International Standards Don’t miss the highlights of the reliable financial ratings and much more, that ensure the integrity of vital features, workshop in the July/August issue of in our next issue. such as quality, ecology, safety, reliabil- ISO Focus. ity, compatibility, interoperability, efficiency and effectiveness.

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