Presentation on theme: "Standard Trends Status of IEC 60601-1 3 rd edition in European Union, USA and Canada By Grant Schmidbauer Nemko USA, Inc. San Diego, CA."— Presentation transcript:
Standard Trends Status of IEC rd edition in European Union, USA and Canada By Grant Schmidbauer Nemko USA, Inc. San Diego, CA
EN :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
EN :2001 – Became mandatory Jan 1, 2004 EN :2010 (EN national standard) – Becomes mandatory Oct 1, 2013 IEC (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 3 rd ed. Standard Trends – IEC/EN
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/EN 60065
IEC : st edition – Published Jan st edition of the standard will not be used for certification, only for development Working on 2 nd edition as testing and certification standard Transition plan described in IEC document 108/362E/INF dated Standard Trends – IEC (1)
Standard Trends – IEC (2)
European Union USA Canada Other countries Status of 3 rd Edition of IEC
European 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, EN 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 XX) currently referencing specific clauses in the 2 nd 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 3 rd 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 3 rd edition are numbered IEC/EN xx.
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 2 nd edition (ie, earth leakage current at 500µA whereas in the 2 nd edition it was 300µA). AAMI is working to resolve the national deviations and a revision or notice will be published. USA (1)
FDA has published ES rd edition to List of Recognized Standards; transition date set for July 1, Currently both 2 nd edition and 3 rd edition is accepted in USA. Expected that NRTLs will allow grandfather of 2 nd edition into the future (unlike EU). USA (2)
Published by CSA as CAN/CSA C22.2 No :2008. Health Canada has published IEC rd edition to List of Recognized Standards; transition date set for June 1, Currently both 2 nd edition and 3 rd edition is accepted in Canada. Expected that NRTLs will allow grandfather of 2 nd edition into the future (unlike EU). Canada
At the current time, many other countries are in process to issue national standards harmonized with the 3 rd Edition For the most current information, please contact the country's public health authorities Other countries
Grant Schmidbauer Nemko USA, Inc Faraday Ave, Suite 150 Carlsbad, CA USA Tel: Fax: Website: Contact Information