Conformity Magazine - September 2008 - (Page 28)

e) Assessment of compliance throughout the lifecycle of the ME equipment or ME system We hope that this article answers some of the many questions about the key issues surrounding IEC 60601-1-2. The references (and their references in turn) will provide much more information for those who wish to pursue the topic further. Keith Armstrong is a principal with Cherry Clough Consultants (www.cherryclough.com) and a frequent contributor to Conformity. He can be reached at keith.armstrong@cherryclough.com. References 1. IEC 60601-1 Ed. 3.0 2005, “Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance.” ISO 14971:2000, “Medical Devices – Application of Risk Management to Medical Devices.” “The First 500 Banana Skins”, Nutwood UK, 2007, order from pam@nutwood.eu.com. IEC 62A/509/DC “IEC Technical Committee No. 62: Electrical Equipment in Medical Practice, Subcommittee 62A: Common Aspects of Electrical Equipment used in Medical practice – Electromagnetic compatibility (EMC) – Deficiencies in the current edition of IEC 60601-1-2” 23rd August 2005 (refers to Edition 2.1 of IEC 60601-1-2). IEC 60601-1-2 Ed. 3.0 March 2007, “Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.” “EMC Regulations and Standards – Standards for Medical Devices”, Robert M Brown, James Conrad, and Frank O”Brien, Conformity 2008 Annual Engineers Reference Guide, www.conformity.com/2141. Council Directive 93/42/EEC of 14 June 1993 concerning Medical Devices, (OJ No L 169/1 of 1993-07-12), www.conformity.com/2142. Council Directive 85/374/EEC of 25 July 1985 concerning liability for defective products (OJ L 21, 07.08.1985 p. 29-33), as amended by Directive 1999/34/ EC of 10 May 1999 (OJ L 141, 4.6.1999, p. 20-21), and corrected by Corrigendum (OJ L 283, 6.11.1999, p. 20). IEC 61508, basic safety publication, “Functional Safety of Electrical/Electronic/Programmable Electronic SafetyRelated Systems,” (seven parts). 10. IEC TS 61000-1-2, basic safety publication, draft 2nd Edition, 77/356/DTS February 2008, “Electromagnetic Compatibility (EMC) – Part 1-2: General – Methodology for the achievement of the functional safety of electrical and electronic equipment with regard to electromagnetic phenomena.” This draft should be available from national standards committees who cover the 60601 series of standards, with the final version of the 2nd Edition published by the IEC by the end of 2008. 11. SMB/3349A/RV, January 8, 2007, “Report of voting on document SMB/3349/R, Report to the SMB of TC 62 and SCs – Exemption of TC 62 and subcommittees from the Safety Pilot Function of SC 65A.” 12. 2004/108/EC in English: www.conformity.com/2143, or in any official European language: www.conformity.com/2144. 13. The EC’s Guide to 2004/108/EC: www.conformity.com/2145. 14. “Summary list of titles and references of harmonised standards related to medical devices” www.conformity.com/2146. 15. Keith Armstrong, “Why EMC Immunity Testing is Inadequate for Functional Safety,” 2004 IEEE International EMC Symposium, Santa Clara, Aug. 9-13 2004, ISBN 0-7803-8443-1, pp 145-149. 16. Keith Armstrong, “Functional Safety Requires Much More Than EMC Testing,” EMC-Europe 2004 (6th International Symposium on EMC), Eindhoven, The Netherlands, Sept. 6-10 2004, ISBN: 90-6144-990-1, pp 348-353. 17. “Design and Mitigation Techniques for EMC for Functional Safety,” Keith Armstrong, 2006 IEEE International EMC Symposium, Portland, Aug. 14-18 2006, ISBN: 1-4244-0294-8. 18. “Validation, Verification and Immunity Testing Techniques for EMC for Functional Safety,” Keith Armstrong, 2007 IEEE International EMC Symposium, July 9-13 2007, Honolulu, Hawaii, ISBN: 1-4244-1350-8. 2. 3. 4. 5. 6. 7. 8. FAST Link www.conformity.com/2140 9. 28 Conformity September 2008 http://www.cherryclough.com http://www.conformity.com/2143 http://www.conformity.com/2144 http://www.conformity.com/2145 http://www.conformity.com/2146 http://www.conformity.com/2141 http://www.conformity.com/2142 http://www.conformity.com/2140

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Conformity Magazine - September 2008 Contents Editor’s Note Commission Adopts Regulations for Internet-Based TRS Services Another Company Fined for Non-Compliance with HAC Requirements FCC Extends “Do-Not-Call” Registry Compliance Requirements Marketing Company Gets $1.4 Million Fine for Junk Faxes EU Commission Codifies Directive on TTE Market Competition EU Commission Releases Updated Standards List for the R&TTE Directive Updated Standards List for the “New” Low Voltage Directive Released New Standards List Released for the EU’s Machinery Directive The ESD Association: Voluntary Standards in Action ESD Open Forum Medical EMC Standards: Towards the 4th Edition of IEC 60601-1-2 iNARTE Informer Pre-Pulse Voltage in the HBM ESD Model Digital Interfaces and EMC Performance ESD Design Buyer’s Guide Product News Commission Publishes Updated Standards List for the EU’s Personal Protective Equipment Directive FDA Links “Human Factors” to Adverse Events with Medical Devices CPSC Actions in the News IEC Standards Update UL Standards Update Product Reviews Telcordia Standards Update From Our “You Can’t Make This Stuff Up” Department Looking Back: Items from Past Issues of Conformity Advertisers

Conformity Magazine - September 2008

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