The 3rd edition of IEC 60601, issued in 2005, is in various states of adoption by regulatory bodies around the world. IEC 60601-1 is the harmonized standard for medical electrical equipment recognized by public health authorities in most countries. Unlike 2nd edition, the 3rd edition requires a risk management file and process conforming to ISO 14971, the international standard for Application of Risk Management to Medical Devices, in order to show product conformance.
In addition to safety requirements, IEC 60601 includes particular standard requirements for functional safety, software, lasers and EMC.
Following are the known global transition dates.
European Union (EU)
General Standard – June 1, 2012
Particular Standards – Varies, noted by the Official Journal (OJ) of the EU
General Standard with Amendment 1 (EN 60601-1:2006/A1:2013) – June 1, 2018
United States
FDA – From January 1, 2014, FDA requires the 3rd edition of the standard for new product submissions, while for existing products the 2nd edition is still acceptable.
NRTL – In March 2014, OSHA announced through a Federal Register Final Notice its incorporation of ANSI/AAMI ES60601-1 into the list of Appropriate NRTL Program Test Standards. This is the U.S. National Version of IEC 60601-1 + A1.
Canada
General Standard – June 1, 2012
Particular Standard – Varies, with a 3-year transition from the date of publication of the particular standard.
Japan
Published June 1, 2012, with potential transition in 2017
South Korea
Classes 3 and 4 + 14 Particular Products – June 1, 2014
Class 2 + 21 Particular Products – June 1, 2015
Class 1 + 19 Particular Products – June 1, 2016
Taiwan & Singapore
Recognize third edition, no transition date announced
MET Labs will continue to provide testing to the 2nd edition of IEC 60601 as long as regulatory bodies continue to recognize it. For those companies launching global products, it may be necessary to maintain a certified 2nd edition test report with local country deviations and also a 3rd edition test report. In those cases, MET offers a dual certification package at a bundled discount.
As a leading medical National Certification Body (NCB), MET can issue a CB Test Report and CB Certificate, for application to CB Scheme participating countries for local marketing approvals.
Contact us for an immediate test or certification need or sign up for an upcoming free webinar on 60601-1 3rd Edition Overview or 60601-1-2 4th Edition Medical EMC.
