Conformity Magazine - September 2008 - (Page 21)

IEC 60601-1-2 is a “collateral” standard under IEC 60601-1, dealing specifically with electromagnetic compatibility (EMC) issues. Since IEC 60601-1 is a medical safety standard, IEC 60601-1-2 is intended to cover EMC issues that concern medical safety. Electromagnetic interference (EMI) can cause software and/or hardware to malfunction, which can, of course, lead to unacceptable risks. [3] is a little book that briefly describes 500 EMI incidents, many of which were associated with functional safety risks, and many of which were associated with medical products. It is a handy reference source when one needs to persuade managers of the safety, and hence financial, implications of inadequate EMC. The development of IEC standards is entrusted to Maintenance Teams, and MT23 looks after IEC 60601-1-2. The addition of a risk-based approach to IEC 60601-1 meant that IEC 60601-1-2 had to be reviewed, and modified as necessary to follow the same approach. On August 23, 2005 MT23 published a report concerning shortcomings in IEC 60601-1-2 (the 2nd Edition, 2001). This report was then published by the IEC on September 23, 2005, as a “Document for Comment,” 62A/509/DC [4], which said: “It has been brought to the attention of MT23 that the 2nd edition of IEC 60601-1-2 is a combination of electromagnetic compatibility and safety requirements, and that safety with regard to electromagnetic influences is not adequately addressed.” “…, the immunity test levels specified in 60601-1-2 were selected for EMC of performance in the normal use environment and may not be appropriate for safety requirements, i.e., they may not provide an adequate margin to assure the safety of ME Equipment and ME Systems.” (Note that the acronym ME, used by the IEC 60601 family of standards means “Medical Electrical.”) The need to respond quickly to the new risk-based requirements in [1] resulted in the 3rd Edition of IEC 606011-2 [5] being published in 2007, but the timescale did not allow the technical issues in [4] to be addressed. So [5] is little more than the 2nd Edition of IEC 60601-1-2, with a general requirement to employ a risk-based approach according to [2] throughout. It contains no suggestions on how to actually do safety engineering using a risk-based approach to EMC. (Some technical improvements were also made in the 3rd Edition and are described in [6], but are not relevant for this article.) IEC 60601-1-2 and Medical Safety Regulations Worldwide IEC 60601-1-2 is recognized by all major markets worldwide, and is widely used as the basis for their regulatory control of the EMC of ME equipment (which includes all electrical, electronic and programmable electronic devices, equipment and systems used for medical purposes) as regards safety. For example, it has been adopted by the European Union with its IEC prefix replaced by EN, for compliance with the Medical Devices Directive [7]. It has also been adopted by ANSI as ANSI/AAMI/IEC 60601-1-2 and is used in the United States as part of the process of gaining FDA approval. [6] includes an excellent discussion of the current state of IEC 60601-1-2 and how it is used in Europe and the U.S. for regulatory purposes. It is important to understand that the various “Amendments” to, and “Editions” of, IEC 60601-1-2 created by MT23 over the years may or may not be adopted by the various national regulatory authorities around the world at any given time. For example, we find that Europe still uses the 2001 version of EN 60601-1-2, and will adopt its Amendment 1:2004 in 2009. In the US the FDA is already using the 2001 version plus A1:2004; however, neither the EU nor the U.S. have yet adopted the 3rd Edition. It is also important to understand that national authorities might modify the IEC version when they adopt it as their regulatory standard. Some of them include a list of their changes in an annex, but some might just make changes to September 2008 Conformity 21 http://www.haefelyemc.com http://www.haefelyemc.com

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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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