Ian, Almost certainly a typo. I am fairly certain that they mean IEC60601-1. The IEC and UL versions are very similar, but the UL version includes national variations for the USA so these will need to be taken into account. You will find the requirements of this standard more demanding than most other safety standards, but all the principles are the same. I'm afraid there is no substitute for reading the standard, making sure that you understand the terminology, and then applying it to your product. I think that understanding and applying the standard is possibly the least part of gaining approval for medical devices. The regulatory requirements and the expectations of the regulators demand as much if not more attention. I can thoroughly recommend the FDA document FDA 97-4179, "Medical Device Quality Systems Manual: A Small Entity Compliance Guide" which can be downloaded from the FDA website.
Best regards, Neil R. Barker C.Eng. MIEE MIEEE MSEE Manager Compliance Engineering e2v technologies ltd 106 Waterhouse Lane Chelmsford Essex CM1 2QU UK Tel: +44 (0)1245 453616 Fax: +44 (0)1245 453410 e-mail: neil.bar...@e2vtechnologies.com Web: http://www.e2vtechnologies.com From: Gordon,Ian [mailto:ian.gor...@bocedwards.com] Sent: 03 November 2003 09:33 To: 'IEEE EMC-PSTC GROUP' Subject: MEDICAL SAFETY STANDARDS All Does anyone have information on these 2 standards: IEC 60101-1 and UL 60601-1? Are they equivalent? I am not certain that the IEC version actually exists - it doesn't appear on the IEC website but a couple of other sites do quote it. This may be a typo from a customer! Any help would be appreciated. Ian Gordon 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: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
