Standard Trends Status of IEC 60601-1 3rd edition in European Union,

Standard Trends Status of IEC 60601-1 3rd edition in European Union, USA and Canada By Grant Schmidbauer Nemko USA, Inc. San Diego, CA

Standard Trends – IEC/EN 60950-1 EN 60950-1:2006 (EN national standard) – Became mandatory Dec 1, 2010 A11:2009 (clarified all EN national differences) – Became mandatory Dec 1, 2010 A12:2011(sound pressure/personal music players) – Becomes mandatory Jan 24, 2013 A1:2010 (technical update) – Becomes mandatory Mar 1, 2013 COR 1:2006 – Minor correction to IEC/EN version of the standard

Standard Trends – IEC/EN 61010-1 EN 61010-1:2001 – Became mandatory Jan 1, 2004 EN 61010-1:2010 (EN national standard) – Becomes mandatory Oct 1, 2013 IEC 61010-2-030 (for measuring circuits) – No date specified in OJ, however standard says Oct 1, 2013 Part 2 standards – Will become mandatory as they are updated to 3rd ed.

Standard Trends – IEC/EN 60065 EN 60065:2002 (EN national standard) – Became mandatory Mar 1, 2007 A1:2006 (minor technical update and national differences) – Became mandatory Dec 1, 2008 A11:2008 (minor technical update) – Became mandatory Jul 1, 2010 A2:2010 (technical update) – Becomes mandatory Oct 1, 2013 A12:2011 (sound pressure/personal music players) – Becomes mandatory Jan 24, 2013

Standard Trends – IEC 62368-1 (1) IEC 62368-1:2010 1st edition – Published Jan 2010 1st edition of the standard will not be used for certification, only for development Working on 2nd edition as testing and certification standard Transition plan described in IEC document 108/362E/INF dated 2009-12-11.

Standard Trends – IEC 62368-1 (2)

Status of 3rd Edition of IEC 60601-1 European Union USA Canada Other countries

European Union (1) The date of withdrawal (DOW) for EN 60601-1 2nd 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, EN 60601-1. For medical devices with relevant particular (Part 2) standards, the DOW has to be checked.

European Union (2) With 50 particular (Part 2) standards (IEC/EN 606012-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 80601-2-xx.

USA (1) Published by AAMI (Association for the Advancement of Medical Instrumentation) as ES 60601-1 (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.

USA (2) FDA has published ES 60601-1 3rd 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).

Canada Published by CSA as CAN/CSA C22.2 No. 60601-1:2008. Health Canada has published IEC 60601-1 3rd 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).

Other countries At the current time, many other countries are in process to issue national standards harmonized with the 3rd Edition For the most current information, please contact the country's public health authorities

Contact Information Grant Schmidbauer Nemko USA, Inc. 2210 Faraday Ave, Suite 150 Carlsbad, CA 92008 USA Tel: 760-444-3413 Fax: 760-444-3005 Email: [email protected] Website: www.nemko.com