The 3rd Edition of IEC 60601-1 has many changes from the 2nd edition. One of the more impactful changes is the requirement for formal risk management on the part of the manufacturer. Additionally, the 3rd edition adds requirements for essential performance and has many other changes -- some obvious and some subtle.
The 3rd edition of IEC 60601-1 was published in 2005. Other standards bodies followed with publications, as follows:
|It’s crucial to understand the changes in the Standard and how those changes affect you as a medical device manufacturer and your medical compliance testing. More importantly, it’s essential to be aware of the transition dates. Companies that are not prepared for the transition could find themselves losing revenues and customers.|
|On June 1, 2012 the 2nd edition of 60601-1 will no longer be valid in Europe for manufacturers who are using that standard alone to show that a product meets the Essential Requirements in the Medical Device Directive (MDD). Thus, if a company wants to continue using the 60601-1 standard to show compliance to the MDD in Europe, they must make the transition to IEC 60601-1 3rd Edition by June 1, 2012. Canada has also set June 1, 2012 as the effective date for compliance to IEC 60601-1 3rd Edition, although this is only for new devices.|
The US FDA has set June 30, 2013 as their effective 60601-1 3rd Edition compliance date, for new devices only. OSHA, however, will still require compliance to the 2nd Edition of 60601-1, as they have expressed concern over the risk management concept. Therefore, while NRTLs may certify products to the 3rd Edition of 60660-1, it would not meet OSHA’s NRTL approval requirement.
If you are confused, we can help! Try some of these helpful links from our 60601-1 expert, Dale Hallerberg:
- Medical Device Directive
- Official Journal for Medical Standards
- CB Scheme exceptions
- IEC TR 62348 maps the clauses from 2nd Ed to 3rd Ed
Corrigendum (Fix editorial errors)
Dale was a part of the IEC 60601-1 third edition development team. To read Dale’s Whitepaper on Transitioning to IEC 606601-1 3rd Edition, visit our 60601 resource page. If you have any questions about IEC 60601-1 3rd Edition, don’t hesitate to email Dale.