>-----Original Message----- >From: Colgan, Chris [mailto:[email protected]] >Sent: Friday, October 26, 2001 7:43 AM >To: '[email protected]'; [email protected] >Subject: RE: FDA > > > >The very basic difference is that the FDA are safety related >and the FCC EMC >related. > >Both have very comprehensive websites.... > >http://www.fda.gov/ > >http://www.fcc.gov/ > >Regards > >Chris Colgan >Compliance Engineer >TAG McLaren Audio Ltd >The Summit, Latham Road >Huntingdon, Cambs, PE29 6ZU >*Tel: +44 (0)1480 415 627 >*Fax: +44 (0)1480 52159 >* Mailto:[email protected] >* http://www.tagmclaren.com The FDA has several references to non-FCC standards. Here's a couple of quotes from the FDA site: "MDS-201-0004, Electromagnetic Compatibility Standard for Medical Devices, October 1, 1979. This standard was developed under contract from FDA by McDonnell Douglas, but was not adopted as mandatory; it is considered a voluntary guideline." "Over the past 20 years, several standards applicable to medical devices were developed with EMC requirements, primarily standards for military products (MIL-STD), the Association for the Advancement of Medical Instrumentation (AAMI) pacemaker standard, and a 1979 medical device EMC standard (MDS-201-0004). The latter two standards were written under contracts from FDA but were not adopted as mandatory; they are considered voluntary guidance. Recently, the international standards development process, in which FDA has participated, has developed significant and appropriate standards. They are not ideal, but when used, they certainly increase product safety. Appendix B lists examples of available standards. CDRH encourages manufacturers of electromedical equipment to use the IEC 60601-1-2 standard, a widely recognized standard issued by the International Electrotechnical Commission, Geneva, Switzerland. [NOTE: IEC recently renumbered the standards, adding 60000 to all previous numbers, so investigators may know it as IEC 601-1-2.] It is a collateral standard to IEC 60601-1, which is a horizontal (product family) standard intended to apply across many medical disciplines. Other standards such as MIL-STDs or some industry standards may be appropriate as well. It is the manufacturer's responsibility to determine the most appropriate specifications and requirements for their devices. If conformance claims have been made in a PMA or the labeling, however, the GMP documents should contain documented evidence consistent with and supporting those claims. The IEC 60601 series currently includes a general safety standard, four collateral standards (systems, EMC, diagnostic x-ray protection, and programmable electrical medical systems), and over 40 particular, or product specific standards that adapt the general and collateral standards. Related international standards contain details of the IEC 60601-1-2 requirements and test methods (e.g., International Special Committee on Radio Interference (CISPR) standards CISPR 11 and CISPR 16, and IEC 61000-4-x which supersedes the obsolete IEC 801-x series). FDA investigators may be aware of IEC 801-2, since many firms have used it to determine requirements for controlling ESD during manufacturing. These standards are subject to frequent revisions and many documents have to be reviewed simultaneously to determine the current requirements. Hence, manufacturers of the same device, claiming to meet the same standard, may have differing specifications. Firms may claim partial or complete conformance to IEC 60601-1-2 or may have alternate test methods or parameters. Partial conformance may be adequate if the firm substantiates and/or justifies the deviations. The IEC 60601-1-2 standard provides various limits on emissions and immunity. While these limits are clear, the pass/fail criteria are not. Therefore, CDRH encourages manufacturers to clearly specify all deviations from the standard, their specific pass/fail criteria, and justifications as part of their GMP documentation. (NOTE that IEC 60601-1-2 is not applicable to in vitro diagnostic devices or sterilizers but may be used.)" Regards, Ed Ed Price [email protected] Electromagnetic Compatibility Lab Cubic Defense Systems San Diego, CA USA 858-505-2780 (Voice) 858-505-1583 (Fax) Military & Avionics EMC Services Is Our Specialty Shake-Bake-Shock - Metrology - Reliability Analysis ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: [email protected] Dave Heald [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: No longer online until our new server is brought online and the old messages are imported into the new server.
