Presentation on theme: "Status of IEC rd edition in European Union, USA and Canada"— Presentation transcript:
1Status of IEC 60601-1 3rd edition in European Union, USA and Canada Standard TrendsStatus of IEC rd edition inEuropean Union, USA and CanadaBy Grant SchmidbauerNemko USA, Inc. San Diego, CA
2Standard Trends – IEC/EN 60950-1 EN :2006 (EN national standard)Became mandatory Dec 1, 2010A11:2009 (clarified all EN national differences)A12:2011(sound pressure/personal music players)Becomes mandatory Jan 24, 2013A1:2010 (technical update)Becomes mandatory Mar 1, 2013COR 1:2006Minor correction to IEC/EN version of the standard
3Standard Trends – IEC/EN 61010-1 Became mandatory Jan 1, 2004EN :2010 (EN national standard)Becomes mandatory Oct 1, 2013IEC (for measuring circuits)No date specified in OJ, however standard says Oct 1, 2013Part 2 standardsWill become mandatory as they are updated to 3rd ed.
4Standard Trends – IEC/EN 60065 EN 60065:2002 (EN national standard)Became mandatory Mar 1, 2007A1:2006 (minor technical update and national differences)Became mandatory Dec 1, 2008A11:2008 (minor technical update)Became mandatory Jul 1, 2010A2:2010 (technical update)Becomes mandatory Oct 1, 2013A12:2011 (sound pressure/personal music players)Becomes mandatory Jan 24, 2013
5Standard Trends – IEC 62368-1 (1) IEC :2010 1st editionPublished Jan 20101st edition of the standard will not be used for certification, only for developmentWorking on 2nd edition as testing and certification standardTransition plan described in IEC document 108/362E/INF dated
7Status of 3rd Edition of IEC 60601-1 European UnionUSACanadaOther countries
8European Union (1)The date of withdrawal (DOW) for EN nd Edition is June 1, 2012 (now published in OJ).The DOW means that all products sold in the EU after that date shall conform to the requirements of the new standard.However, this DOW (June 1, 2012) for medical devices is only for the Part 1 standard, ENFor medical devices with relevant particular (Part 2) standards, the DOW has to be checked.
9European Union (2)With 50+ particular (Part 2) standards (IEC/EN XX) currently referencing specific clauses in the 2nd Edition, the DOW for medical devices with particular (Part 2) standards, will not be set until the particular (Part 2) standard has been updated with references to specific clauses in the 3rd edition.The transition period for medical devices with particular (Part 2) standards will be extended as necessary (generally 3 years after DOP).Some Part 2 standards harmonized with 3rd edition are numbered IEC/EN xx.
10USA (1)Published by AAMI (Association for the Advancement of Medical Instrumentation) as ES (not published by UL!).Missing several of the USA national deviations that were part of 2nd edition (ie, earth leakage current at 500µA whereas in the 2nd edition it was 300µA).AAMI is working to resolve the national deviations and a revision or notice will be published.
11USA (2)FDA has published ES rd edition to List of Recognized Standards; transition date set for July 1, 2013.Currently both 2nd edition and 3rd edition is accepted in USA.Expected that NRTLs will allow grandfather of 2nd edition into the future (unlike EU).
12Canada Published by CSA as CAN/CSA C22.2 No. 60601-1:2008. Health Canada has published IEC rd edition to List of Recognized Standards; transition date set for June 1, 2012.Currently both 2nd edition and 3rd edition is accepted in Canada.Expected that NRTLs will allow grandfather of 2nd edition into the future (unlike EU).
13Other countriesAt the current time, many other countries are in process to issue national standards harmonized with the 3rd EditionFor the most current information, please contact the country's public health authorities
14Contact InformationGrant Schmidbauer Nemko USA, Inc Faraday Ave, Suite 150 Carlsbad, CA USA Tel: Fax: Website: