Rarely has a standard change elicited as much confusion – and anguish – as the transition to the third edition of 60601-1.
Much of the confusion surrounds the varying rates of adoption of the new edition in different countries and regions. Here is a basic primer:
IECEE CB Scheme – Issued in 2005, IEC 60601-1 3rd edition is effective now, but so is the 2nd edition, which is still acceptable in many markets. It’s usually up to the user/buyer/distributor to determine what level of certification he wants.
European Union – EN 60601-1 3rd edition is effective June 1, 2012, but can be used now. Some part 2 standards may have an earlier adoption date and thus require use of the 3rd edition before June 1, 2012.
Canada – CSA C22.2 NO. 60601-1-08 is effective June 1, 2012, but can be used now. Health Canada will continue to accept declarations of conformity to the second edition of IEC 60601-1 until June, 2012. After June, 2012 Health Canada intends to only accept declarations to the third edition of IEC 60601-1, and the related collateral and particular standards.
United States – UL has published AAMI ES 60601-1, Ed. 1. Acceptance of this standard or the previous edition is up to the user/buyer/distributor. Though it may be used now it’s not OSHA-recognized yet, so NRTL certification must still be to UL 60601-1 2nd edition. The FDA does recognize AAMI ES 60601-1: 2005, but will continue to accept declarations of conformity to IEC 60601 2nd edition until June 30, 2013.
The anguish surrounding the third edition is attributable to the much stiffer requirements of the standard. Most significantly, the 3rd edition requires that the manufacturer establish a risk management file and process as outlined in ISO 14971, the international standard for Application of Risk Management to Medical Devices.
Because of these new requirements, third edition certification projects are typically double to triple the duration and cost of their second edition equivalent.
2 Comments on IEC 60601-1 3rd Edition Challenges Medical Products Industry
Update from a recent OSHA bulletin:
“We have reviewed the standard but not yet approved its use under the NRTL Program. Our main concern with this standard, which is based on the third edition of IEC 60601, is the risk management file concept. We plan to develop and propose criteria that NRTLs must meet in order to rely upon or make use of this risk management file. NRTLs would be recognized for this standard only if they meet the criteria. Until OSHA has approved these criteria, however, we cannot be sure how or when we will allow the use of the standard. Because we have not yet recognized any NRTLs for this AAMI standard, products certified to it would not meet OSHA’s NRTL approval requirement.”
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