New white paper: IEC 60601-1: Changes from 2nd to 3rd Edition
Posted 26/07/08 | Permalink | |
Some time ago, Intertek offered some webinars on the changes of the new edition of IEC 60601-1. Now they published a “white paper” resuming the subject, which can be obtained in the following link resumido sobre o assunto que pode ser baixado a seguir: IEC 60601-1: Changes from 2nd to 3rd Edition.
It´s a good start for people not aware of the changes.
23/10/08
A word of caution on publications and seminars on 60601-1: 2005 (Ed. 3) and the associated collateral standards. As with any new topic, there are a lot of “experts” out there that don’t know what they are talking about. As convener of one of the working groups that developed the standard and the Secretary of an associated Subcommittee, I see a lot of incomplete, misleading and just plain bad information on the 3rd Edition and 14971. Check out the credentials of anyone offering information on the 3rd Edition (did they do more than attend a seminar or just read the document?).
Information that’s not often mentioned:
While the new 60601-1 General Standard doesn’t contain too many nasty surprises itself, compliance with applicable collateral standards is now mandatory and there are 11 (12 within a year or so) that contain significant and new requirements.
Health Canada has come to its senses and will not require the 3rd Edition begining this December. New “drop dead” date is 6/2012.
Technically the 3rd Edition has NOT been harmonized in the EU yet but should be listed in the OJ in the first qrtr. of 09. However, for devices without a particular standard (”part two” device specific standards in the 60601 series) the forward of EN 60601-1 states that you can’t use Edition 2 (EN 60601-1: 1990) after September of 2009! We expect that this will be resolved (allowing a 3 year transition) after listing as a harmonized standard but the situation merits watching!