Compliance for s Mike Violette, P.E. Steve Koster, Washington Laboratories, Ltd Washington Labs & ACB EMC, Environmental, Product Safety & Radio Frequency Expertise Commercial Consumer Defense & Aerospace Energy Wireless Certifications WL Project Experience 15,000+ projects since 1989 NASA Raytheon US Army, Air Force & Navy General Electric Westinghouse Hughes Network System Applied Physics Laboratory Exelon 35+ Nuclear Power Plants Research Universities Over 500 individual clients Partner Laboratory Agenda Your Presenters Mike Violette Steve Koster President, WLL Vice-President, WLL Director ACB Agenda Overview • Background: Mike Violette • Regulatory Overview US/CN: Steve Koster • Technical Requirements • Measurements • Regulatory Overview EU: Mike Violette • Regulatory Overview Asia/Aus: Mike Violette Agenda Overview • Background: Mike Violette • Regulatory Overview N.A.: Steve Koster • Technical Requirements • Measurements • Regulatory Overview EU: Mike Violette • Regulatory Overview Asia: Mike Violette Kickstarter Phenomenom Some Background - Crowdsourcing • $1 Billion pledged ($380M in 2013) • 7.6 Million backers (>200 Countries + Territories) • “Rewards” depending on pledged amount, timing • Technology, Publishing, Theater, Games Post cards to Rock and Roll Some Projects Dreamers I ($34,000 pledged) Some Projects Dreamers II ($5600 pledged) Some Projects Innovators ($1.3M pledged) Some Projects Innovators Streaming video: $8.6M pledged, 10X Goal! Some Projects Technology Projects 872 Active Projects Example Project IT Device: >$3.0 M Pledged 11,860 Backers USA 2676 UK 442 Germany 347 Canada 262 Australia 256 Netherlands 142 Switzerland 111 France 105 Backers Japan 104 Norway 77 Singapore 65 Russia 56 Italy 53 Sweden 53 Belgium 49 Spain 48 Austria 40 Backers … Libyan Arab Jamahiriya 1 Tanzania 1 Panama 1 84 Countries! Nigeria 1 New Caledonia 1 French Polynesia 1 Georgia 1 Why Are We Here? Compliance? What could go wrong? • Electrical Safety • Mechanical Safety • Biological • Radio spectrum • Materials selection • APPROVALS Compliance? • What Needs to Go Right? Compliance? • What Needs to go Right? Compliance Definitions - Consumer EMC: Electromagnetic Compatibility Spectrum: Wireless Transmitters Product Safety Protection from Electrical, Mechanical, Fire and Chemical Hazards Environmental: ROHS: Restriction on Hazardous Substances WEEE: Waste Electrical and Electronics Equipment REACH: Registration, Evaluation, Authorisation & Restriction of Chemicals OTHER Toy Safety Explosive Atmospheres (ATEX) Pressure Vessels Automotive Safety Safety Issues Mechanical Safety Electrical Safety IEC60950 is dominant standard for IT SAR & MPE (OET Supplement C, IEEE 1528, IEC 62209) Laser Safety FDA CDRH Compliance Definitions - Consumer Declaration of Conformity (DoC, sDoC) • “Self-Certification” Third-Party Certification • CB Scheme Accreditation Compliance Definitions - Consumer Regulatory Requirements North America Regulations • EMC: FCC & Industry Canada – Intentional and Unintentional – Licensed and Unlicensed • Safety: NEC & OSHA, Provincial, NOM • Medical: FDA 510(k) Premarket Notification • Laser: FDA CDRH EUROPE Directives: EMC Directive Low Voltage Directive Medical Device Directive Machinery Directive Radio and Telecommunications Terminal Equipment Directive => “RED” Self-Declaration allowed for many products “Essential Requirements” Notified Body for certain classes (notably medical and some telecom and some machinery) EUROPEAN DIRECTIVES Low Voltage (2006/95/EC) > 2014/35/EU Simple Pressure Vessels (2009/105/EU) Toy Safety (2009/48/EC) Construction Products (89/106/EEC) Amended by 93/68/EEC *EMC (2004/108/EC) > 2013/30/EU *Machinery (2006/42/EC) Personal Protective Equipment (89/686/EEC) Non-Automatic Weighing Instruments (90/384/EEC) Amended by 93/68/EEC Gas Appliances (2009/142/EC) Hot Water Boilers (92/42/EEC) Amended by 93/68/EEC *Medical Devices (2007/47/EC) Explosive Atmospheres (94/9/C) > 2014/34/EU Recreational Craft (94/25/EEC) Automotive (2007/46/EC) and others *Active Implantable Medical Devices (90/385/EEC) *Radio and Telecommunications Terminal Equipment Directive (1995/5/EC) > 2014/53/EU WEEE (2012/95/EU) ROHS Directive (2011/65/EC) * Contain EMC Provisions “Electrical and Electronic Equipment” EU Environmental Directives ROHS: Restriction on Hazardous Substances (RoHS) Minimize hazardous metals in landfills: Pb, Hg, Cd, Hexavalent Chromium, Polybrominated Biphynels, Polybrominated Diphenyl Ethers WEEE: Waste Electrical and Electronic Equipment Recycling and disposing of electrical equipment REACH: Registration, Evaluation, Authorization and Restriction of Hazardous Chemicals Regulatory Requirements Other Markets? • Country-by-country specific • Most countries regulate radio spectrum • Many countries regulate product safety • Some countries (and the EU) regulate materials in products Compliance Strategies Determine target market(s) requirements Refer to International Standards (International Electro-technical Commission) IEC Source components that are already approved Agenda Overview • Background: Mike Violette • Regulatory Overview US/CN: Steve Koster • Technical Requirements • Measurements • Regulatory Overview EU: Mike Violette • Regulatory Overview Asia: Mike Violette US Regulations • Code of Federal Regulations Title 47: – Part 2: General Requirements » §2.1091, §2.1093 * – Part 15, Unlicensed – Part 22, 24: Licensed » Cellular devices – Part 87, 90: Licensed » Marine, Land-Mobile *SAR: ANSI C95.1-1991: Non-ionizing Radiation Hazards Canada Industry Canada Requirements • ICES-CS03: Unintentional Emitters • Digital Apparatus • RSS-GEN: Overall • RSS-119: Licensed • Land mobile • RSS-210: Unlicensed • Short range, low power • “Most” technical requirements harmonized with FCC Compliance For Wireless Equipment Two Main Areas for EMC • Conducted and Radiated Emissions – (FCC, IC, RTTE) • Conducted and Radiated Immunity (For Europe) ALSO: Network connection protocols for Mobile Devices (cellular devices) •CTIA, PTCRB (Cellular Telecommunications Industry Association PCS Type Certification Review Board) FCC Authorizations FCC has authority over radio spectrum since 1934 “to make available…a rapid, efficient, nationwide, and worldwide wire and radio communication service…for the purpose of the national defense…” Federal Communications Commission • Responsible for integrity of the airwaves • Use of spectrum • Licensing and operation of RF systems • Certification • Database of thousands of products: • Frequency • Power • Limitations on Use • Responsible Party • RF Safety FCC Equipment Authorizations Verification: least-interfering equipment Class A Digital Devices Radio receivers Declaration of Conformity (DOC) Class B Digital Devices (computers & peripherals) Certification Intentional Transmitters (unlicensed and licensed) IC Authorization Industry Canada has overview Authority on Spectrum Similar technical limits and rules “Verification” for digital devices Certification for radio transmitters Wireless Explosion FCC Certifications in 2000: 4,011 devices FCC (+TCB) Certifications in 2014: 19,000+ Power levels from mW to hundreds of watts Unlicensed low power proliferating Broadband technologies expanding Frequency Allocations expanding Grant of Equipment Authorization Transmitter Grantee Frequency & Power Grant Notes FCC ID Provides Device Details FCC ID: AAAAAnnnnnnnnnnnnnn AAAAA: is Grantee Code from FCC. Identifies the responsible party (Grantee) nnnnnnnnnnnnnn: is from Manufacturer https://fjallfoss.fcc.gov/oetcf/eas/reports/GenericSearch.cfm FCC Database FCC CFR 47 Regulations http://www.gpoaccess.gov/ecfr/ Part 2 General Requirements Part 5 Experimental Radio Service Part 15 Subpart C, D, and E Unlicensed Low Power Transmitters Part 20 Common Carrier Part 21 Domestic Public Service Part 22 Public Mobile Service Part 24 Licensed PCS FCC CFR 47 Regulations Part 25 Satellite Communication Services Part 26 General Wireless services Part 27 Miscellaneous Wireless Services Part 68 Telecom Services Part 73 Education Services Part 74 Television Broadcast Part 80 Maritime Service FCC CFR 47 Regulations Part 87 Aviation Part 90 Private Land Mobile Part 95 Personal Radio Service Part 97 Amateur Radio Part 100 Digital Satellite Broadcast (Eliminated and now requirements are in Part 25) Part 101 Fixed Microwave KDB FCC’s Knowledge Database system Most topics have some sort of guidance or KDB written about them https://apps.fcc.gov/oetcf/kdb/index.cfm IC accepts guidance from most of these KDBs KDB system is used to ask the FCC about any non-standard test methods Permit But Ask (PBA) Limits on TCBs: PCB PBA: Typically “New Technologies” If your device is on the PBA list If guidance is clear, such as confidentiality of a photo or user manual, then TCB can guide If the PBA is due to test procedures, you will typically need to contact the FCC through the KDB system to resolve all testing issues before testing begins Submit your KDB communication with the FCC, to the TCB at the time of Certification Technical Requirements Applies to ALL Devices Unlicensed versus Licensed Licensed devices are more regulated and are protected Unlicensed devices are unprotected. Some historical basis in the Industrial Scientific and Medical (ISM) Bands (13.56 MHz, 2.4 GHz, e.g.,) Unlicensed Examples WiFi Bluetooth Cordless phones Remote control devices (most) UWB devices Spread Spectrum UNII Unlicensed use is UNPROTECTED Licensed Devices Land mobile radio Cellular telephones (blanket license) Broadcast transmitters (*Docket 20780 ca 1979)