Issue 47 January 2016

Contents Industrial Gases Council (IGC) Andrea Mariotti, 2016-2017 Chair IGC Chair’s Report...... 1 During the past two years the EIGA Industrial Gas Council met eight times under the Chairmanship of Christoph Herrmann. On behalf of my IGC colleagues, all our Working Group experts and the MGC Chair’s Report...... 2 EIGA staff, I want to thank Christoph for his leadership of IGC and the work performed under his chair in the coordination of the work groups and the international harmonisation effort. REC Chair’s Report...... 2 The activities to identify any gaps in the EIGA library and to discover any areas where potential safety issues are not yet fully addressed continued in the second half of 2015. This process is key SAC Chair’s Report...... 4 to identify and close gaps which could result in incidents, and also to demonstrate that our industry is capable of being self-regulated. EIGA Office News...... 4 After the completion of the gap analysis of Air Separation Plant operations in 2014, the analysis of Publications...... 6 two additional important work areas were recently completed. The Working Group 12 acetylene experts held a final meeting by video conference with their counterpart experts in CGA. Working Group News...... 6 Although all the most critical safety issues are already covered in EIGA documents some opportunities for harmonisation projects were identified and will be addressed in the near future. The Transport (WG-1)...... 6 joint working group identified as their first priority the mechanical integrity of acetylene plants. Mechanical integrity or plant ageing; the effect whereby a component suffers some form of material Gas Cylinders and Pressure deterioration and damage with an increasing likelihood of failure over the plant lifetime is increasingly included in authority inspections. Ageing is not always related to how old the equipment is, Vessels (WG-2)...... 7 the time in service is an important factor and the acetylene plants are among the older plants in use in our business. The integrity of process plants can be ensured by a documented programme Process Equipment (WG-3)... 7 of procedures, training, inspections and tests and through a preventive maintenance based upon Special Gases (WG-4)...... 7 good engineering practice. The second area is where our experts in AHG-I.20 made an analysis of the EIGA library for indus- Environment (WG-5)...... 8 trial cylinder operations. Several recommendations for new documents to be developed and for the revision of existing ones were made. Among them the ageing of filling plant was also included Cryogenic Vessel Standards together with manual handling of containers, material selection, safe filling plant layout and safe operation. Together with road transport, the operation of filling plants and the manual handling of (WG-6)...... 8 containers is an area of work where incidents happen more frequently. A large number of these incidents are related to human factors or human errors and the frequent belief amongst many engi- Medicinal Gases (WG-7)...... 9 neers and managers is that these kinds of errors are both inevitable and unpredictable. However, a human error is most probable if people are placed in situations that emphasise human weaknesses Food Gases (WG-8)...... 9 and that do not support human strengths. A good plant layout and clear safe operational procedures are fundamental to reduce such incidents. Classification, Labelling & Among the many valuable documents published in the second half of 2015, I would like to men- SDS (WG-9) �� 9 tion in particular two new publications issued by EIGA under the programme to develop globally harmonised publications: Homecare (WG-10) �� 10 EIGA Doc 200: Safe Design, Manufacture, Installation, Operation and Maintenance of Valves Used in Liquid Oxygen and Cold Gaseous Oxygen Systems and EIGA Doc 202: Mechanical Integrity Hydrogen Energy (WG-11) �� 10 of Syngas Outlet Systems. Both documents will contribute to increase safety and reliability of our installations. Acetylene (WG-12) �� 10 For more details please contact the IGC chair: Mr Andrea Mariotti at SOL Group (I) Security (WG-13) �� 11 Tel.:+39.039.2396.361 Fax: +39.039.2396.377 - E-mail: [email protected] Medical Equipment (WG-15) � 11

EUROPEAN INDUSTRIAL GASES ASSOCIATION AISBL AVENUE DES ARTS 3 - 5 • B - 1210 BRUSSELS PHONE +32 2 217 70 98 • FAX +32 2 219 85 14 E-mail: [email protected] • www.eiga.eu

EIGA Doc 200: Safe Design, Manufacture, Installation, To promote our industry in the supply of medical gases and Operation and Maintenance of Valves Used in Liquid respiratory homecare services, focusing on the quality Oxygen and Cold Gaseous Oxygen Systems and EIGA Doc and efficacy of our products and services to enhance 202: Mechanical Integrity of Syngas Outlet Systems. Both patient safety. documents will contribute to increase safety and reliability of The three permanent MGC working groups focus on the our installations. respective areas of the industry: For more details please contact the IGC chair: Mr Andrea Mariotti WG-7, Medical Gases at SOL Group (I) Tel.:+39.039.2396.361 Fax: +39.039.2396.377 - E-mail: [email protected] WG-10, Respiratory Homecare WG-15, Medical Devices (e.g. valves, connectors, medical Medical Gases Council (MGC) pipeline systems in hospitals) Kenth Drott, 2016-2017 Chair In addition there are currently six ad hoc groups that are each As the incoming chairman of the Medical Gases Council and working on a specific topic over a limited time period. on behalf of all the MGC members, I would like to start by As can be seen, the Medical Gases Council and the entire thanking Alain Combier of Air Liquide for his excellent team working in the various groups are covering a lot of work during his chairmanship over the last two years. ground in the healthcare area. We look forward to the Modern medicine would be unimaginable without medical challenges and opportunities that our industry faces in 2016 gases. Throughout the community, wherever care is provided and beyond, always with our mission in mind to promote the - in emergency settings such as ambulances, in acute care in safe supply and use of medicinal gases, devices and services. hospitals, or care in patients’ own homes - medical gases st Finally I would like to thank all members of the working play a vital part in the delivery of 21 century healthcare. groups and ad-hoc groups of MGC for their dedication and Megatrends such as ageing population, better access to excellent work within EIGA in 2015, and wish you all a safe, healthcare and improved technology mean that medical healthy and successful 2016. gases, devices and related services are increasing in their For more details please contact the MGC chair: Kenth Drott at significance to the gas industry. But with changing Linde, Tel: +49 173 159 5589, E-mail: [email protected] customer, quality and regulatory requirements the difference between medical and technical gases is increasing, posing a Regulatory Environment Council (REC) number of challenges and opportunities for EIGA members. Chris Szweda, 2015 – 2016 Chair The regulatory landscape is becoming more and more This report covers the period from June 2015 since when we complex and it is critical to understand the changes, how they have started to see a ramp up of work from the European impact our industry and what we can do to influence or Commission on many policy fronts. Most importantly for our mitigate any negative consequences. industry, on 15th July 2015 the Commission published their Many of our medical gases are pharmaceuticals and from a proposal to revise the EU Emissions Trading Scheme (EU regulatory point of view are treated in the same way as any ETS), a culmination of the results and analysis from the key other drug. However the pharmaceutical legislation is consultation on EU ETS structural reform for 2020 and typically written with “pills” in mind which makes it difficult beyond held in March and to which EIGA contributed. to interpret from a medical gases perspective. And since the REC members quickly set about analysing the draft EU ETS medical gas business has some unique characteristics which proposal text to evaluate the potential consequences for our are very different to traditional pharmaceuticals, it happens industry. The analysis confirmed that there is a strong from time to time that new regulations put strange and possibility that in 2019, when the Commission will come unnecessary demands on our industry which calls for EIGA forward with a new list of sectors and sub-sectors deemed to to try to influence wherever possible. Some of our gases and be exposed to carbon leakage, the industrial gas sectors’ key equipment are not treated as drugs but instead as medical products hydrogen, syngas, oxygen and nitrogen, will no devices which is again a different regulation that has been longer be included in this list. The Commission has developing very fast in recent years. proposed a new calculation method where industries now The MGC and its three working groups have the task to need to meet a certain threshold based on carbon intensity follow the development of medical gases and devices and and trade intensity. Under the proposal, the trade intensity take actions in the best interest of the EIGA members. The analysis will be carried out at NACE 4 level (rather than mission of MGC is: PRODCOM level as used for the previous carbon leakage To set standards for our industry and users in the safe list). Under the previous method of calculation, sub-sectors supply and handling of medical gases, devices, and could qualify under just one of two criteria. In addition our respiratory homecare services (through the development detailed analysis also revealed inconsistencies in the text of best practices and the production of Medical Gases between two articles – Article 10a (benchmarks) and Article Council publications). 10b (carbon leakage criteria) which could lead to distortion To provide regulatory agencies and healthcare providers of competition between insourced and outsourced production with specialist advice on the standards used for the safe of hydrogen, nitrogen and syngas. EIGA has also initiated production, supply, handling and administration of work and restarted an alliance with aligned chemical and oil medical gases and healthcare services (in line with the refining sectors that we worked with in 2008 on the EU ETS pharmaceutical industry). Phase III legislation, where there were similar risks noted and © EIGA 2016 2 EIGAZETTE No 47 - January 2016 a strong desire to work together and resolve common issues. European Council Member States rejected binding national EIGA also met with the key policy makers in the renewable and energy efficiency targets. Commission. This revealed that the Commission were not 2016 has already been dubbed by the Commission the “year aware of the inconsistencies but were willing to work with of implementation” - over the course of the next 12 months, EIGA on possible solutions. On a positive note we could see the European Commission will come forward with legislative in the text that the Commission had shown a strong proposals to translate the 2030 Climate and Energy understanding of the importance of a level playing field for Framework agreed by Heads of State in October 2014 into outsourced (versus captive) production of vital industrial legislation. These proposals will be presented in three gases such as hydrogen, syngas, oxygen and nitrogen. separate legislative packages over the course of 2016. The Sustaining the outsourcing business model is not only vital to REC will be monitoring these proposals. As we move EIGA members’ business interests but also brings further into 2016 the REC will also be examining the demonstrable benefits to European manufacturing industry, Commission’s review of the Energy Efficiency Directive and both in terms of its environmental performance (reducing will need to monitor closely what this means to the industrial greenhouse gas emissions in Europe) and its economic sector. Sources close to the work have indicated that there performance. will be no specific target for energy efficiency in the In the autumn the shape of the process for taking the proposal industrial sector as the focus may need to be on sectors such through the European Parliament became clear as the as buildings and there is hopefully no political appetite to rapporteur for the lead ENVI committee (Ian Duncan, a target energy intensive industries further. The REC will Scottish ECR MEP) was appointed. EIGA was able to meet examine a consultation document and develop an appropriate with Mr Duncan’s advisors to start the process to explain our response. issues and the risks to our industry. EIGA also learnt that the In addition to the Energy Union, the REC also reviewed the work of Mr Duncan’s report on the proposal would most Commission work programme for 2016 which has a number likely start after the December UN climate conference in of elements of interest for us. Overall, we can expect a very Paris. The 2016 timetable for review of the proposal will busy legislative agenda in 2016 as the Commission seeks to include a public hearing in February, consideration of a draft translate the European Council Conclusions of 2014. Of report in the ENVI Committee in April with a deadline for interest to EIGA are the following: amendments from MEPs to the ENVI Committee at the end of that month. Consideration of amendments in the Proposal on non ETS sectors: This effort sharing decision Committee will continue in June with votes in the ENVI proposal will cover business, agriculture and the de- Committee in September and Parliament’s plenary vote carbonisation of transport. The Commission will propose expected in November 2016. At the end of November 2015 legislative proposals to achieve a 30% reduction in these the REC started to formulate a list of possible MEPs with non ETS sectors by 2030. whom we can share our concerns and whom we expect to Renewables 2030 targets: The European Council have the opportunity to meet with and present our solutions Conclusions set the EU renewables target for 2030 at to in early 2016. 27% binding at the EU level but not binding at the EIGA also met with the UK Department of Energy and individual Member State level. Proposals to achieve this Climate Change (DECC) to discuss these issues. DECC will are expected in the second half of 2016. be a key stakeholder in supporting the rapporteur. As this Gas package: Although not mentioned anywhere in the newsletter goes to print, members of the REC will have met Work Programme, the Commission is expected to come with the Commission to develop solutions which we will use forward with its ‘Gas Package’ in Q1 2016. This is to communicate to key stakeholders to gather support as expected to include an LNG and energy storage strategy amendments are put forward by MEPs and Member States and an EU Strategy for Heating and Cooling. take their positions. Colleagues will also be meeting Finally, EIGA continues its work on the Biocidal Products Member States. We can see the developing key areas for Regulation (BPR) under the support of a newly formed ad debate between the Commission and the Member States hoc working team, looking at the generation of ozone from coming on benchmarking and most importantly the carbon oxygen. leakage list. The Biocide Product Registration (BPR) has been in effect Energy and climate integration will move from the policy- since September 2013. It calls for approval of an active makers wish list to development of formal proposals in 2016 substance, in this case ozone, at EU level. Four dossiers have as we see greater integration of these two policy areas. The been submitted by EURO3ZONE, a consortium of ozone REC continues to monitor the Energy Union policy and in manufacturers, for the generation of ozone from air, water the last week of November reviewed the Commission and oxygen as precursors. These correspond to four publication of its First State of the Energy Union report. The identified biocidal ozone uses (drinking water, food and feed report, which was accompanied by twenty five documents, disinfection, waste water disinfection and cooling water). gave an assessment of where Europe is in terms of achieving The next step will be the authorisation for a biocidal product, the objectives laid out in the Energy Union Strategy of at Member State level. Someone in the supply chain must February 2015 and set out a snapshot of the current situation. hold such an authorisation. By September 2017, use is Most important of all however, and perhaps of most interest forbidden if not authorised. to EIGA, are the steps it takes to give greater guidance on how the Energy Union will be governed and how the EU Also, in case oxygen is supplied “with intent to” produce renewable and energy efficiency targets for 2030 will be ozone, registration as a supplier has been required since achieved. At present, it remains unclear exactly how much September 2015. Oxygen supplied as a generic commodity scope the EU will have to enforce these targets, as the product is still possible.

© EIGA 2016 3 EIGAzette No 47 – January 2016 EIGA is cooperating with the consortium and the authorities EU industrial and medical gas industry safety performance, reviewing the dossiers for ozone to ensure that the oxygen providing us with important input for our future work. specification in the dossier is satisfactory. SAC’s work at glance: EIGA is supporting the consortium to ensure that our SAC meetings are a forum to exchange information and industry can continue to supply oxygen for ozone generation. experience on recent gas industry-related incidents, as well as For more information, contact Mr Chris Szweda REC Chair at The to analyse their causes and prepare an incidents resume Linde Group (UK). Tel:. +44-1483-579857 report. I would like to draw your attention to the quarterly e-mail [email protected] incident Training Package. SAC’s ambition here is to Safety Advisory Council (SAC) provoke discussion and new ideas on how to improve safety in our industry. Rainer Wysotzki, 2016-2017 Chair I am pleased to be able to present my first report as Chairman Furthermore, SAC shares its expertise with other EIGA of SAC. working groups, giving them the opportunity for better defining their course of action. Many of the lessons thus But firstly, on behalf of all SAC members, I want to thank learnt find their way into EIGA publications compiled and my predecessor Danilo Ritlop and his assistant Christoph published by SAC or other EIGA working groups, including Schütz, for their leadership of our group over the past two valuable safety information designed for EIGA members and years. It is a great challenge for me and my colleague other stakeholders. Margot Timmermans who will take the responsibility of SAC Secretary, to run SAC for the next two years. SAC, jointly with working groups under its responsibility (WG-5 Environment, WG-9 CLP & SDS and WG-13 An important part of SAC’s mission and responsibilities is to Security), covers the following EIGA work areas: safety, maintain EIGA’s accident databases and accident statistics, health, environment, product stewardship and security. with the aim of monitoring EIGA safety performance. Let us take a look how the gas industry has been doing recently. Ad-hoc working groups under SAC are busy developing materials to support improvement in transport safety, process The accident performance for the 12 months to the end of safety, health and hygiene, product safety, worker safety. September 2015 shows the lowest number of lost time Additionally ad-hoc working group REACH closely monitors injuries reported in the history of EIGA. the development of the REACH Regulation in order to 124 injuries were reported, resulting in a Lost Time Injury verify, influence or initiate changes. Frequency Rate (number of injuries per million worked As the transport of gases in private vehicles has been hours) of 1,57 that is the lowest in the history of EIGA. The recognised as a hazard that is widely underestimated, SAC Lost Time Injury Severity Rate (number of lost days per has decided to create a new ad-hoc group that will try to million worked hours) has also improved. Employee injuries develop new guidelines for the gas industry. An additional resulted in 2.473 lost days, 561 fewer days lost than in the ad-hoc group on occupational health will start their work in previous 12 months. Consequently the Lost Time Injury 2016. Severity Rate decreased from 39,4 to 31,35. An LTI Severity rate of 30 currently seems to be a ‘borderline’ for our I want to thank all members of the SAC working groups for industry. contributing a huge effort to develop and revise new and existing documents. You can find reports of the working I am sad to report four fatalities related to our industry in groups in this EIGAzette. 2015. In December, a contract driver died in Greece as a consequence of a head-on collision of his LOX tanker with SAC challenges for 2016: another truck. The man leaves behind a wife and three  In compliance with the new EIGA strategic children. SAC were also advised of incidents that resulted in priorities, to find a way to identify consistently ‘bad the death of three third parties. These fatalities were performers’ and how to help these companies to improve exclusively a consequence of road traffic accidents. Safety in their safety performance. transport of gases, closely related to contractors, is the  Further developing guidance on transport safety. second industry safety challenge.  Achieving progress in contractor management. Also negative is the trend in Recordable Working Injuries  Further developing strategies on how to influence (RWI). The RWI Frequency rate increased from 3,1 RWIs human behaviour. per million worked hours to 3,38. According to the  Encouraging National Associations to interact more experience of the SAC members the RWI trends should closely with SAC. follow the LTI trends. The increase of the RWI rate could be For more information, please contact Mr. Rainer Wysotzki, a consequence of better reporting of RWIs by EIGA SAC chair, at Praxair (Germany) Tel.+49 211 2600 4131 members. We will monitor this closely in the future. Fax .+49 211 2600 55 131 E-mail: [email protected] We have to remember that each accident is preventable and unacceptable as it results in people suffering. This not only EIGA Office News reminds us of the importance of EIGA's work, but also gives us an additional impetus to support further improvements in safety. EIGA Annual General Meeting 2015 th th Human error is still seen as a major cause of injuries. Thus The 25 Annual General Meeting was held on 5 June 2015 tackling human factors and human behaviour is the industry’s in Milan, Italy and welcomed 89 delegates and their partners new challenge for improving safety performance. to take advantage of the EXPO 2015 being held in the same city. The AGM included a number of special presentations. The EIGA Annual Report on Work Injury Statistics for 2015 The winner of the 2014 Peter Jackson Award was PanGas will be published soon. It will provide deeper insight into the © EIGA 2016 4 EIGAzette No 47 – January 2016 AG, Switzerland and Robert Krieger, their Chief Executive Mr Stefano Varisco, SIAD, Italy Officer, collected the prize and gave a presentation on the Our thanks go to Wiebe Buist, Colin Trundley, Jean-Paul safety activities in the company. The Working Group Award Beens and Alan Ross of Yara; Giangiacomo Caldara and 2014 was presented to Chris Szweda of The Linde Group, the Giacomo Rota of SIAD; and Aidan Constant of Irish Oxygen Chairman of the Ad Hoc Group, AHG-R.1 – F-gases. He for their contributions to EIGA, we wish them well. provided the AGM with a review of the key activity that has National Associations occupied the Ad Hoc Group, and for which they were recognised with this award, ensuring our industry’s interests Following on the annual National Associations (NA) meeting in Grimbergen in April 2015, a meeting was held on were considered in the new EU regulation intended to th regulate the phase-down of the supply of fluorinated 29 October 2015 at EIGA’s offices in Brussels. The NA greenhouse gases - hydrofluorocarbons or HFCs. The AGM meeting was attended in person or by conference call by guest speaker was Alessandra Lanza, Partner in Prometeia representatives from 13 of EIGA’s 25 National Association SpA and Head of Industrial and Regional Strategies, who affiliates. The participants were able to discuss some of the spoke on the subject of “Made in Italy excellence: towards a issues of common interest impacting our industry at a new renaissance?”. national level. A special presentation was made to Dr Aldo Belloni. The Board of Directors of EIGA had decided to recognise one of Working Group Meetings its former members for his long years of service and his great In 2015, EIGA Councils, Working Groups, Ad-hoc Groups contribution to EIGA’s cause by inviting him to the Summer and Task Forces held 181 meetings, 50% of these meetings Session in Milan, the city of his birth, and to thank him for were net meetings or teleconferences. the support he has given to EIGA and its mission for many International Harmonisation Council (IHC) years. The IHC and observers from the IOMA Global Committee Full details of these presentations as well as those of the four (GC) companies met in Seattle in July to review the progress Council chairmen can be found in the AGM Minutes in on current projects and the resources required to complete Bulletin N° 45 on the Members Area of the EIGA website. projects in development. In 2015, ten (10) harmonisation EIGA Safety Awards projects were closed, i.e. all the associations have published The 2014 Safety Awards were presented at the AGM. The their version of the same document. Three (3) of these were EIGA Company Awards, based for the first time on the new publications and seven (7) are revisions. EIGA and CGA recordable work injury performance went to Praxair Europe harmonised and published seven (7) publications – three (3) in Category 1; Gulf Cryo, United Arab Emirates in Category new and four (4) revisions. The major workload is now 2 and Air Liquide Maroc, Morocco in Category 3. revising existing publications and keeping them harmonised. Road Safety Awards were presented to Praxair Deutschland In 2015, IHC also completed with a global team of experts a (Bulk Vehicles, more than 5 million km annually); AGA AS, gap analysis of harmonised publications that have been Norway (Bulk Vehicles, 1 million – 5 million km annually); developed for acetylene plant operations. Some gaps were Linde AG, Germany (Cylinder Vehicles, more than 2 million identified that could be filled by harmonised publications and km annually) and Linde Gas GmbH, Austria (Cylinder these will be the subject of future harmonisation projects. Vehicles, 0,5 million - 2 million km annually). ‘Zero International Harmonisation Award Accident’ Awards were presented to 118 Member company The 2015 International Oxygen Manufacturers’ Association locations in 11 groups of companies. (IOMA) International Harmonisation Award was presented New Members during the IOMA Annual Meeting in Rome in November. At the AGM, Tyczka Air Austria GmbH and Strandmöllen This year’s award recipient was David Birch of The Linde AB Sweden were approved as new Active Members of Group, a long term member of EIGA’s WG-2 (Gas Cylinders EIGA. and Pressure Vessels). Elections for Category 2/3 Representatives to EIGA Mr. Birch received the award from Stefan Messer, IOMA Councils and Board President, based on his commitment to harmonization, his Following the election process for 2015 EIGA’s independent team leadership and technical expertise, which have been member companies elected representatives of Category 2 and instrumental to the successes of the International Category 3 Companies to Board of Directors, IGC, MGC, Harmonisation Council’s (IHC) activities. He has worked REC and SAC for their term of office in 2016 and 2017 as tirelessly to develop international standards, primarily for gas follows: cylinder valves and related matters. His involvement helped Elected Representatives for Board of Directors to achieve agreement that led to the publication of a complete suite of standards relating to valves that are now referenced Mr Finbar Constant, Irish Oxygen, Ireland in both the UN Model Regulations for the Transport of Mr Bernardo Sestini, SIAD, Italy Dangerous Goods, as well as in European Transport Elected Representative for IGC Regulations. Mr. Birch has worked on the compatibility of None nominated materials with high pressure oxygen, contributing Elected Representatives for MGC significantly to the knowledge and understanding of this Dr Heinz Hoffmeyer, Westfalen AG, Germany subject leading to improved industry safety. Mr Carlo Nasso, SIAD, Italy EIGA extends our congratulations to David Birch. Elected Representative for REC Mr Giorgio Bissolotti, SIAD, Italy Now in its eleventh year, this annual award is presented to an Elected Representatives for SAC individual who best exemplifies the character, commitment, Mr Finbar Constant, Irish Oxygen, Ireland and technical excellence prevalent in the development of © EIGA 2016 5 EIGAzette No 47 – January 2016 harmonised publications or legislation at the international  SA 25: Disposal of Surplus and Used Company Clothing level. (WG-13) IOMA Global Committee also has a programme to recognise  SA 26: Unmanned Aerial Vehicles (Drones) - Guidance to the contribution of participants in the harmonisation working EIGA Members (WG-13) groups and IHC recommended that over 90 participants in thirteen projects receive certificates and letters from IOMA Training Packages (for EIGA members only) GC to recognise their contribution to the development of  TP 45: Recent Incidents in the Industrial and Medical these publications. Gases Industry - SAC 142 (SAC)  TP 46: Life Saving Rules Presentation (SAC) EIGA Events  TP 47: Recent Incidents in the Industrial and Medical Gases Industry - SAC 143 (SAC) For your diaries: th th  TP 48: Global Standards Development - Harmonization EIGA Winter Session 2016, 27 – 28 January 2016, Overview (EIGA) Brussels – Carbon Dioxide Training Course (ongoing)  TP 49: Recent Incidents in the Industrial and Medical EIGA National Associations’ Meeting, 13th - 14th April Gases Industry - SAC 144 (SAC) 2016, Bratislava, Slovakia EIGA Summer Session 2016, 2nd - 4th June 2016, Berlin, Technical Bulletins Germany  TB 14: Lime and the Definition of Waste (WG-5) EIGA Winter Session 2017, 25th – 26th January 2017,  TB 15: Energy Efficiency: Compliance with Legal Brussels – Human Factors Requirements and Best Practices (WG-5)

E-mail EIGA office: [email protected] Safety Leaflets Publications  SL 06: Life Saving Rules Brochure (SAC)  SL 07: Life Saving Rules Poster (SAC) Please visit www.eiga.eu to download the following publications (new since the last issue of the EIGAzette): Working Group News EIGA Documents  Doc 60: Seveso Documents - Guidance on Applicability, Transport (WG-1) Assessment and Legal Documents for Demonstrating Most of the documents under the responsibility of WG-1 Compliance of Industrial Gases Facilities with Seveso have been recently revised. WG-1 members continue to be Directive(s) (SAC) closely involved in proposed amendments for ADR 2017 and  Doc 132: Unmanned Air Gas Plants: Design and Operation EIGA is still present in the relevant international meetings. (WG-3) Some of the potential changes in ADR 2017 which concern  Doc 138: PTFE Used as a Sealant for Cylinder/Valve the gas industry include new definitions, new provisions in Connections (WG-2) line with the UN orange book for composite cylinders, and  Doc 139: Safe Preparation of Compressed Oxidant-Fuel the introduction in ADR 6.8 of the requirement for the actual Gas Mixtures in Cylinders (WG-4) holding time to be determined for cryogenic portable tanks  Doc 160 Corrigendum: Code of Practice - Silane (WG-4) journeys. With reference to the last item, WG-1 will update  Doc 169: Classification, and Labelling Guide in accordance EIGA Doc 184: Methods to Prevent the Premature with EC Regulation 1272/2008 (CLP Regulation) (WG-9) Activation of Relief Devices on Transport Tanks which will  Doc 198: Security and Safety for Homecare Field Personnel be referenced into ADR 2017 and which provides guidance (WG-10) for the calculation of the actual holding times.  Doc 199: Safe Handling of Electronic Specialty Gases The replacement of MLA 237 on DOT cylinders is also a (WG-4) major issue since the MLA expires in June 2016. Many  Doc 200: The Safe Design, Manufacture, Installation, discussions have already taken place with the authorities and Operation and Maintenance of Valves Used in Liquid EIGA will present detailed information concerning the Oxygen and Cold Gaseous Oxygen Systems (WG-3) situation of these cylinders in Europe, the figures and the  Doc 201: Near-Consumer Use – Risk Assessment gases concerned to the Joint Meeting of RID/ADR. In Methodology (SAC) parallel, work with CGA is ongoing for mutual acceptance of  Doc 202: Mechanical Integrity of Syngas Outlet Systems European cylinders being imported and emptied in the US. (WG-14) WG-1 is also providing assistance on national issues concerning the local implementation or interpretation of EIGA Office Publications (for EIGA members only) regulations. As an example, due to questions raised by some  EIGA 908: 300 Bar Residual Pressure Valve Filling countries concerning the authorisation in ADR for the drivers Connectors (WG-2) to connect and open cylinders at customer sites, WG-1 will  EIGA 919: Guidelines for the Preparation of Safety Data publish a Briefing Note confirming that this activity is fully Sheets (WG-9) in line with the ADR provisions.  EIGA 924: Life Saving Rules (SAC) For more information please contact Mr Christophe di Giulio, Chair of WG-1 at Air Liquide (France) - Tel: +33.1.58.07.86.02 Safety Alerts (for EIGA members only) Fax: +33.1.58.07.83.40 - E-mail: [email protected]

© EIGA 2016 6 EIGAzette No 47 – January 2016 Gas Cylinders and Pressure Vessels (WG-2) After editorial revision the document will be sent out for Highlights: approval prior to publication. EIGA WG-2 has received an increasing number of requests Currently WG-3 members are working on the revision of the for contribution to harmonisation and standardisation issues. following harmonised documents: Also the joint meetings with ECMA (European Cylinder Doc 10: Reciprocating Compressors for Oxygen Service, a Makers’ Association) are continuing to show benefit. draft is awaiting IGC approval. Progress with Publications: Doc 149: Safe Installation and Operation of PSA and The following harmonisation projects are in progress: Membrane Oxygen and Nitrogen Generators, in December a conference call of the joint working group was held to - Revision of Doc 64: Use of Residual Pressure Valves. resolve the comments on this document. - Revision of Info 22: Potential Hazards of Quick Opening Cylinder Valves Used with Firefighting Gases. Doc 154: Safe Location of Oxygen and Inert Gas Vents, a complete review of the document is now deemed to be The following EIGA documents are in development: required. Until then the existing document shall be reviewed  New Technical Bulletin on ‘-40 °C’ marking on briefly with the target to quickly publish a revised version. cylinders/valves; For more information, contact Mr Dirk Reuter, Chair of WG-3, at  New Training Package on prefill inspection of gas Messer Group (Germany) - Tel: + 49.2151.7811.141 – cylinders; Fax: 49.2151.7811.511 E-mail: [email protected]  Revision of Doc 91: Use of Pressure Relief Devices for Special Gases (WG-4) Gas Cylinders;  New Technical Bulletin on use of PRDs on composite International harmonisation: tubes; WG-4 continues to work on the development of  Revision of Doc 62: Internal Corrosion of Cylinder. internationally harmonised documents with members of the Additional activities: CGA, JIMGA and AIGA. A series of net-meetings have been held with the Associations to address comments - CGA: Support to the import and export of DOT and received on harmonised documents, including: European Cylinders and Pressure Receptacles into Europe and the US Revisions to Doc 39: Safe Preparation of Compressed - ECMA: Particles tests for cylinders Oxidant-Fuel Gas Mixtures in Cylinders to take account of - UN: participation on the informal working group on changes detailed in ISO 10156: 2010 Gases and gas mixtures “Provisions on equipment for tanks and pressure – Determination of Fire Potential and Oxidising Ability for receptacles” including proposals for revising the text of the Selection of Cylinder Valve Outlets and additional RID/ADR/ADN concerning pressure receptacles. preventive measures recommended following an incident have been completed. The document was published in June Outlook: 2015. WG-2 has taken the initiative to produce new work items Current activities are focussed on the development and which will cover the integrity of steel cylinders during use. revision of the following documents: For more information, contact Dr. Wolfgang Dörner, Chair of WG- New publication Safe Handling of Hydrogen Selenide (A- 2, at Linde AG Tel: +49 89 7446 1304 FAX: +49 89 7446 2599 E-Mail: [email protected] 1110) Revision to Doc 162: Code of Practice: Phosphine Atmospheric Gases Process and Equipment (WG-3) Revision to Doc 163: Code of Practice: Arsine In July 2015 Gregory DeVincentis was nominated as the new Revision to Doc 140: Code of Practice: Fluorine and Air Products representative on WG-3. Gregory is based in Fluorine Mixtures the US and is also a member of the CGA Atmospheric Gases Revision to Doc 92: Code of Practice: Nitrogen Trifluoride. Committee, so providing a useful link to their work. Witold EIGA documents: Balczarczyk from Linde Group was confirmed as new vice A review of Doc 161: Gas Compatibility with Aluminium chairman. Alloy Cylinders has been initiated and net meetings arranged The new harmonised document Doc 200: Safe Design, to address comments arising. Manufacture, Installation, Operation and Maintenance of International Standardisation – ISO Standards: Valves Used in Liquid Oxygen and Cold Gaseous Oxygen Systems was published. This important document outlines WG-4 continues to participate in the development and review requirements for valves in cold oxygen systems to avoid of several ISO Standards, including: incidents with potentially fatal consequences. ISO 11114-1:2012: Gas cylinders - Compatibility of cylinder and valve materials with gas contents-Part 1: Metallic Documents in progress: Two new ad hoc groups under the sponsorship of WG-3 were materials established: AHG I.21 Cleaning for Oxygen Service and Current issues which are still the subject of ongoing AHG 3.17 Liquid Oxygen Valves in Customer Stations. Both discussions include: groups will have their initial meetings in the first quarter of Nitric oxide - should be accepted in aluminium alloy 2016. cylinders as in the previous version of the standard. WG-4 The ad hoc groups AHG 3.13 Leak before Break in Flat does not support the request to modify the present version of Bottom Storage Tanks and AHG 3.14 Cryogenic Flat Bottom the standard in order to allow pure phosgene, silicon Storage Tanks – Risk Assessment have finished their work. tetrachloride, silicon tetrafluoride and trichlorosilane in aluminium alloy cylinders.

© EIGA 2016 7 EIGAzette No 47 – January 2016 ISO/FDIS 14456: Gas cylinders – Gas properties and Documents in progress: associated classification (FTSC) codes WG-5 continues to work on the acetylene cylinder BREF Determination of properties of gases and gas mixtures - (Best available technique Reference Document). comments received on the FDIS version of this standard were Publications Doc 110 Environmental Impacts of Cylinder addressed at an ISO TC58/SC2/WG-7 meeting in July. ISO Filling Plants and Doc 111 Environmental Impacts of 14456 replaces the content in ISO 5145:1990, Cylinder valve Carbon Dioxide and Dry Ice Production have been reviewed outlets for gases and gas mixtures — Selection and and their revisions will be republished shortly. dimensioning which deals with FTSC codes. WG-5 has completed work on a document on Management of ISO 13338: 1995 (classification for corrosivity): Waste Gas Cylinders and this is now going through the Determination of tissue corrosiveness of a gas or gas review and approval process and should be ready for mixture. publication early in 2016. This document will build on the The standard was reviewed at the ISO TC58/SC2/WG-7 advice in Doc 166: Guidelines on Management of Waste meeting in July 2015. Further work is required prior to Composite Cylinders, but will cover all types of gas submission of the revised standard as a DIS. cylinders. ISO 10156: 2010 (classification for flammability and EIGA WG-5 monitors, and seeks to influence current and oxidizing potential): Gases and gas mixtures - Determination proposed legislation, exchange information on environmental of fire potential and oxidizing ability for the selection of incidents/events and develops and recommends valve outlets. environmental best practice and indicators. The standard is currently undergoing revision and a new draft For more information, contact Mr Stephen Bradley, WG-5 Chair, at has been circulated following the July ISO working group Air Products Plc (United Kingdom). Tel: + 44 1932 249 992 meeting. Actions will be progressed during the next working Fax: + 44 2086.364.810 E-mail: [email protected] group meeting arranged for February 2016. Cryogenic Vessels (WG-6) Working group meetings A work item request has been prepared to develop a The AHG-4.10 continues to work on the development of a document for ethylene to address common incidents. WG-6 draft ISO 6142-2 standard which details the production of is developing this document which should be published in gravimetrically prepared calibration mixtures. An ISO 2016. TC158 WG-3 ‘Gravimetric Methods’ meeting will review WG-6 has started the revision of Doc. 06 on Safety in the draft during their December 2015 meeting. Storage, Handling and Distribution of Liquid Hydrogen. The next WG-4 meeting is arranged for February 2016. The need to revise publications Doc 24: Vacuum Insulated For more information, contact Dr Kevin Cleaver, Chair of Cryogenic Storage Tank Systems Pressure Protection WG-4, at BOC Gases (United Kingdom) Tel: + 44.1483.244.308 Devices, Doc 114: Operation of Static Cryogenic Vessels, Fax+ 44.1483.45.07.41 E-mail: [email protected] and Doc 119: Periodic Inspection of Static Cryogenic Environment (WG-5) Vessels has been considered by WG-6 members. Revisions of Doc 24 and Doc 114 are well advanced. This year we again invited nominations for the EIGA environmental awards. We received twelve good ISO Standards: nominations which demonstrated the commitment of EIGA The ISO Technical Committee formed to develop Cryogenic member companies to environmental improvements. The Vessel standards has published all the necessary standards. results will be announced early in 2016. Standards which are available are the ones concerning Legislation: materials, operational requirements and the design standards for small and large transportable vessels. The last meetings EIGA responded to the commission consultation on the of this ISO TC and the corresponding WGs took place on Circular Economy. This consultation was very general but 16th – 20th June 2015 in Beijing. Revision of standards has we will be using this to push for an exemption from started including the ones on operational requirements. A packaging legislation for reusable gas cylinders, on the basis new standard on cryogenic pumps is being prepared. The it supports the objectives of the Circular Economy. standards for impact toughness are being revised. In WG-5 have issued a Technical Bulletin on the Energy particular, they will allow careful re-pressurisation of tanks Efficiency Directive (TB 15: Energy Efficiency: Compliance where carbon dioxide has solidified. The next meeting will with Legal Requirements and Best Practices). It details the be held in Paris from June 6th to 8th, 2016. requirements under the Directive to have audits by CEN Standards: 5th December 2015. There are thresholds for the size of the company (number of people and financial turnover) below The last CEN TC 268 meeting took place in Paris on th which the energy audit is not required. September 8 , 2015. Discussion took place mainly on ISO 20421-2 Cryogenic vessels - Large transportable vacuum- The Fluorinated gases regulation 514/14 (Regulation (EU) insulated vessels - Part 2: Operational requirements (ISO/DIS No 517/2014 of the European Parliament and of the Council 20421-2:2013). Most of the comments have been resolved. of 16 April 2014 on fluorinated greenhouse gases and The final comments were expected to be resolved with the repealing Regulation (EC) No 842/2006) is now finalised and TPED consultant in November 2015. The scope of the TC is EIGA Doc 192 Fluorinated Gases Management (under now extended to also cover hydrogen energy activities. This revised Regulation 517/2014) contains guidance on the is covered by a new working group (CEN-WG5). The first labelling provisions of the regulation. The EIGA CLP guide meeting of CEN-WG5 took place in January 2015 and the has been updated by WG-9 to support this. next meeting was organised in Paris in September 2015. The

© EIGA 2016 8 EIGAzette No 47 – January 2016 main difficulties to resolve in the hydrogen are purity and Carbon Dioxide Fountain Quality Guideline is under quality control requirements. revision. For more information, contact Mr H. Barthélémy, Chair of WG-6, Regulatory Watch: at Air Liquide (France) Tel: +33 1 40 62 55 01 ADR 2015 included new rules (Chapter 5.5.3) regarding Fax:+33 (0) 1 40 62 57 95 e-mail : [email protected] safety marking for coolants in vehicles and containers using a cryogenic agent, like carbon dioxide snow. Medical Gases (WG-7) For more information, contact Mr Philippe Girardon, Chair of Pharmacopoeia: WG-8, at Air Liquide (France) - Tel: +33.1.39.07.69.68 Fax+33.1.39.07.65.53 E-mail: [email protected] After the participation of WG-7 members in Group 9G of the European Pharmacopoeia, Intermix monographs have been Classification, Labelling, SDS (WG-9) published in Pharmeuropa. These monographs will become The mission of WG-9 is to: standards for the industry and should be useful for member companies in the preparation of medical dossiers for lung Monitor, and influence when needed, new and revised function gases. legislation on classification and labelling of pressure receptacles and the preparation of Safety Data Sheets GMP Guideline: (SDSs). After the publication of GMP Guideline Part I, the Group is Publish recommendations on how to comply with the now working on GMP Part II which covers the manufacture relevant legislation. of gases classified as Active Pharmaceutical Ingredients The mission of TF-9.1 is to develop with the company (API). WG-7 is preparing a technical bulletin on the LISAM S.A. an SDS authoring tool that is compliant with identification of starting materials and API in medicinal legislation and EIGA’s recommendations. gases manufacturing. Legislation: Package Information Leaflet (PIL): Information to submit to Poison Centres WG-7 is making a survey around Europe in order to check where it is possible to provide a PIL for patients and user WG-9 is following closely the development of new available in electronic format. Final objective is to have the legislation to harmonise throughout the EU the information possibility to avoid providing paper PIL in all countries and to be submitted to the National Poison Centres when new provide only electronic format PIL. hazardous mixtures are placed on the market. WG-9 managed to have gas mixtures that have no hazard other than Pharmacovigilance: “being under pressure” to be excluded from the scope of the WG-7 is working on collecting the major types of adverse directive. The new legislation is expected to be approved by drug reactions in order to harmonise their classification in mid-2016 with a stepwise implementation period spread from member companies. July 2019 for consumer mixtures to July 2021 for industrial For more information, contact Mrs Stefania Mariani, Chair of mixtures. WG-7, at SOL Group (Italy) Tel: +39.039.239.63.90 The submission shall be done using a defined XML format. Fax: +39.039.239.63.71 E-mail: [email protected] WG-9 together with other industry sectors are testing the Food Gases (WG-8) proposed application to generate the XML files and have Work in progress: submitted comments to the Commission. The publications in the custody of WG-8 governance that Adaptations to Technical Progress (ATPs) of the CLP were last issued during the period 2008-2010 and are related The 8th ATP that aligns CLP with the 5th revision of the GHS to carbon dioxide are still under revision, targeted for will be published in March. The 9th ATP will be published completion by the end of 2016. A common publication is later in 2016. Both ATPs have no major impact on gases. planned to consolidate information and guidance on the Labelling of pressure receptacles containing F-Gases general properties of carbon dioxide and considerations such The new Regulation (EU) 2015/2068 (OJ dd. 18/11/2015) as handling, hazards, etc. instead of duplicating the defines the new labelling elements that are required in the F- information in each separate carbon dioxide document. Gases Regulation 517/2014. The new phrases are already Compliance: considered in the 2015 edition of EIGA Doc 169. Metals migration tests on food gases through a complete gas EIGA documents: installation (i.e. bulk or cylinder supply, heater, piping The EIGA CLP guides Doc 169: Classification and Labelling distribution, etc.) will start in January 2016 with the financial Guide and Doc 919: Guidance on the Compilation of Safety support of AFGC, the French National Industrial Gases Data Sheets” were republished in August 2015. WG-9 is Association. With these data the gas companies will be able now working on new updates for both documents to be to produce material compliance certificates to meet requests published at the same period in 2016. Doc 169 will be from customers or notified bodies. updated to incorporate the relevant changes from the ATPs to Metals and Alloys Specific Limit Releases have been the CLP. Doc 919 will be updated with a new Annex that published in a practical guide by the Council of Europe. An will outline the structure of the Exposure Scenario (ES) with electronic version is available at www.edqm.eu/register . the relevant library of phrases needed to generate ESs for A joint approach together with WG-2 and WG-7 is being gases. considered as a future work item. SDS authoring tool: The International Society of Beverage Technologists (ISBT) TF 9.1 completed the testing and approval of the new EIGA has finally issued their Nitrogen Quality Guideline. Their compliant SDS authoring tool from LISAM called GCM © EIGA 2016 9 EIGAzette No 47 – January 2016 ExESS v15 that is replacing the GCM OMNIS version that Hydrogen Energy (WG-11) has been in use for the last 15 years. The OMNIS version WG-11 has been focusing on the development of the will not be maintained anymore by EIGA and all EIGA international standards for hydrogen refuelling stations in OMNIS users should contact LISAM in order to migrate conjunction with ongoing work at ISO TC197 WG24 and their database to ExESS if this is not already done. CEN TC 268 WG-5. TF 9.1 is working on the update of ExESS v15 in order to Much of this is driven by the publication of the EU directive improve some functionalities and align the database with on the deployment of alternative fuels infrastructure EIGA Doc 919. One of the major improvements will be the (2014/94/EU). ability to publish the Exposure Scenarios that have been prepared and approved by WG-9 for several gases. WG-11 has been asked by CEN TC268 WG5 to propose a draft document for a European standard for hydrogen quality. Working group chair and membership: It has also been asked to undertake discussions with the car Joachim Eiselt of Air Liquide and Ben Valk of Linde who manufacturers (OEMs) with respect to such a European have been chairing WG-9 and also TF 9.1 (Joachim Eiselt) standard. stood down as chairmen. On behalf of all WG-9 members, A risk analysis approach has been developed within WG-11 we want to thank Joachim and Ben for their significant to support the adaptation of the existing ISO 14687-2 contributions and fruitful lead of the working group during dedicated to hydrogen quality specification for vehicles into a the past years. European standard and to propose the basis of a QA approach Sara Livesu is the new Air Liquide representative on WG-9. for hydrogen. WG-9 is now chaired by Joachim Barbe of Messer and A taskforce under EIGA WG-11 has met with car TF 9.1 is chaired by Ewoud Beheydt of Praxair. manufacturers and several workshops took place in 2015. For more information, contact Mr Joachim Barbe, Chair of WG-9, The working group is continuing its work on other key topics at [email protected] or Mr Ewoud Beheydt, chair including acceptance tests; safety distances definitions and of TF-9.1 at [email protected] methodologies and refuelling risk analysis. WG-11 has Homecare (WG-10) participated to ISO TC197 and CEN TC268 meetings related to the new Hydrogen Energy WG-5. In recent months a document was issued to provide guidance on security and safety for homecare field personnel. The The group has contributed to the European project publication is intended to enable EIGA members to prepare CERTIFHY for the definition of “Green/decarbonized guidance for field staff such that they, their managers and Hydrogen” certificates. schedulers are better able to identify potential threats and For more information, contact Mr Guy de Réals, Chair of WG-11, risks when delivering products and services to patients’ at Air Liquide (France) Tel.:+ 33.1.39.07.69.05 e-mail: homes. These homes can be in areas subject to high [email protected] criminality leading to risks to staff during the delivery Acetylene (WG-12) process. Some of the patients and patients’ relatives, or people in the area, have been known to threaten and assault In the second half of 2015, WG-12 worked mainly on member company staff. These threats and assaults have finishing a gap analysis of the existing documents related to included physical and verbal abuse as well as the use of acetylene, a harmonisation project. All the existing gaps in weapons. EIGA and CGA publications were identified during a number of joint conference calls in July and August. At the end of The intent of this document written jointly with the WG-13 this process, with a dedicated two day video conference (Security) is to provide guidance so that staff can stay safe session in October, the gaps have been grouped and and secure when undertaking their duties. prioritised. We are also working on the revision of Doc 89: Medical Two topics of common interest were identified for new Oxygen Systems for Homecare Supply. The updates are to globally harmonised documents: take into account the current and future trends in Homecare devices, which are increasingly portable, light and small and Mechanical integrity of acetylene plants. which did not exist a few years ago. This is the case for Investigation of different design criteria for acetylene portable concentrators or the self-fill systems. equipment (different operating limits on pressure and We have received information on three safety incidents temperature). concerning Homecare vehicles and we are analysing this to WG-12 has also proposed to develop a new EIGA confirm that the information in our guidelines concerning publication on calcium carbide and other raw materials design of vehicles used in medical oxygen deliveries (Doc (acetone, DMF), their specifications and test methods. 128) are an effective barrier to such events, when In the meantime, the drafting of two new documents implemented. continued: In this sense it is important that member companies follow Acetylene customers’ installations is now in draft form and the guidance in our documents down to the operational level will be edited/modified in the next meetings, and also share it as widely as possible to the National Associations so that companies that are not EIGA members Acetylene plants design and operation is in development. can also benefit from our safety recommendations. WG-12 continues monitoring the DMF restriction process For more information, contact Mr Antonio Lima, Chair of WG-10, at and is supporting the Italian Authorities during the DMF Air Liquide Health Care (France) - Tel: +33.1.49.69.45.81 restriction proposal discussions. E-mail: [email protected]

© EIGA 2016 10 EIGAzette No 47 – January 2016 Regarding participation in ISO standardization committees, For more information, contact [email protected] no significant recent activities have been reported by the Medical Equipment (WG-15) WG-12 members. The scope of WG-15 has been clarified by MGC and gases For more information, contact Mr Lorenzo Beretta, Chair of WG-12, at SOL Group (Italy) - Tel: + 39.039.23.96.376 that are classified as medical devices, for example carbon fax + 39.039.23.96.420 - E-mail: [email protected]. dioxide and liquid nitrogen, are now clearly under our responsibility in the same way as the medical hardware used Security (WG-13) in the supply of medical gases to patient (pipeline systems, We have had an unprecedented period within our industry Valves with Integrated Pressure Regulators (VIPR), etc.). and in Europe from terrorist actions. We need to be vigilant Medical device Regulatory Watch: in these critical times and WG-13 is working hard to ensure The final text of the new Medical Device Regulation is still that we can provide a secure environment for us all. awaited. A new draft of the Annexes was made public in WG-13 has published two Security Alerts; SA 25: Disposal September 2015. of Surplus and Used Company Clothing and SA 26: WG-15 has closely studied the Annex concerning the Unmanned Aerial Vehicles (Drones). General Safety and Performance Requirements, known as the Both these documents are prepared and published to provide Essential Requirements in the current medical directive. In EIGA member companies with guidance and points to take spite of a considerable increase in the number of into account when considering the two subjects. More requirements and in the length of the text (+70%), no critical specifically SA-25 looks into how clothing and products with issues for the medical equipment in our scope have been company logos affixed should be disposed, considering that found, except for a significant workload to update our such items have in the past been used inadvertently by others technical files. in an inappropriate way or context. It is important to WG-15 has also reviewed the Annex concerning remember that with good intention, clothing can be re-issued classification. The way the new classification rules are to third party organisations and used or seen in a manner written could lead to a reclassification of carbon dioxide in which we may consider unsuitable. SA 26 is seen as a new class III, mainly when used in virtual colonoscopy. Same area of security which needs consideration as the availability issue for liquid nitrogen when used for vitrification of human and use of drones through the world has exponentially cells (direct contact). If it is confirmed, this would lead to a increased in the last year or so. These drones are highly significant burden including specialized notified body and sophisticated with high quality images being available to the clinical trials. WG-15 will monitor closely. user, who needs little or no experience to be able to purchase or fly one of these units. The thought may also come to mind Standardization: that those intending to cause damage to our facilities and The revision of ISO 7396-1 standard on pipelines systems is industry may use these to gain information without needing now complete and the standard will be published in the next to gain direct access. two months. The most significant change is the introduction Doc 198: Safety and Security of Homecare Field Personnel of oxygen concentrators, formerly covered in a separate has become available and it describes best practices, standard. procedures and protocols which should be considered to The revision of the ISO 10524 series on pressure regulators allow homecare personnel to stay safe. It is difficult to (10524-1: pressure regulators for cylinders, 10524-2: line and provide a 100% guarantee to all homecare staff but if time is manifold regulators and 10524-3: VIPRs) has been launched taken to consider the surroundings and environment in the last ISO TC121/SC6 meeting in December in Milan. including taking simple steps when leaving vehicles and Regarding the VIPRs, an Ad Hoc Group has been created to entering premises then we hope to mitigate or significantly handle the overlapping areas between ISO 10524-3 and ISO reduce most issues, without placing any individuals in 10297, the standard on cylinder valves which is referenced in dangerous environments. ADR. We have two documents which have been sent for final The new drafts of these three standards will soon be available approval Fraud and Fraudulent Behaviour and Security for a second round of comments which will be reviewed Guarding Guidance for EIGA Members. We anticipate that during the next TC121 plenary meeting that will be held in both documents will be approved shortly and will be May 2016 in Chicago. available to members. The flow outlets fitted on all medical devices used for The scope and terms of reference for WG-13 has been delivering an oxygen flow to the patients is the well-known refreshed. It was felt that the original document was corrugated nipple, also known as hose barb or fir-tree. This prepared on the basis that the security group may be a short connector is also used as a flow inlet on the patient interfaces term requirement and thus was worded accordingly. such as masks and cannula. Unfortunately it would seem that this is now a much needed An alternative connector has been developed and is described group providing necessary support to EIGA member in an ISO standard (ISO 80369-2). This family of connectors companies and therefore we needed to change this to reflect are called small-bore connectors and the one for breathable the change in scope. gas application is known under the nickname of R2. The WG-13 has a number of new members following the primary aim of this new connector is to prevent retirement of a number of representatives. The companies misconnection between oxygen tubing and an intra-venous now making up WG-13 are representatives of Air Liquide, catheter, which can be a fatal adverse event. Introducing a Air Products, Messer Group, The Linde Group, SOL and new connector is not free from risk. EIGA raised concerns Yara. two years ago indicating that using R2 connectors on patient

© EIGA 2016 11 EIGAzette No 47 – January 2016 interfaces was right but that replacing the current nipple on delivery devices as VIPRs would lead to a situation where users would not be able to supply oxygen to the patient because they have not the correct connector (corrugated nipples and R2 connectors are not compatible). TC121 has created an Advisory Group to give recommendations concerning the use of corrugated nipples and R2 connectors on respiratory devices (delivery devices, patient interfaces, tubing). The consensus statement of the Advisory Group will be issued soon and we can reasonably expect a wise and positive outcome. For more information, contact Mr Benoît Marchal, Chair of WG-15, at Air Liquide (France) - Tel: + 33.1.49.69.83.60 E-mail: [email protected]

Disclaimer All technical publications of EIGA or under EIGA’s name, including Codes of practice, Safety procedures and any other technical information contained in such publications were obtained from sources believed to be reliable and are based on technical information and experience currently available from members of EIGA and others at the date of their issuance. While EIGA recommends reference to or use of its publications by its members, such reference to or use of EIGA’s publications by its members or third parties are purely voluntary and not binding. Therefore, EIGA or its members make no guarantee of the results and assume no liability or responsibility in connection with the reference to or use of information or suggestions contained in EIGA’s publications. EIGA has no control whatsoever as regards, performance or non-performance, misinterpretation, proper or improper use of any information or suggestions contained in EIGA’s publications by any person or entity (including EIGA members) and EIGA expressly disclaims any liability in connection thereto. EIGA’s publications are subject to periodic review and users are cautioned to obtain the latest edition.