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Major IEC 60601-1 3rd Ed changes 9-14-10

Major IEC 60601 -1 3rd Ed. changes Why 90% of Medical Products Do Not Comply Presented By: Michael Brousseau Engineering Team Leader Medical Devices Group Tel: + 1 (978) 635-8670. Transition to 60601 -1, 3rd Edition (In the EU part 2 standards may complicate this, however). Country / Agency 2005 2006 2007 2008 2009 2010 2011 2012 2013. USA (ETL mark) 2nd 3rd optional FDA 2nd 3rd optional 3rd Canada (ETL mark) 2nd 3rd optional Health Canada 2nd 3rd optional 3rd EU 2nd 3rd optional 3rd CB Scheme 2nd 3rd optional ??? FDA has announced an official date of 2010-06 when they will accept submissions to 3rd edition. The 3rd Edition will be Mandatory 2013-06-01. Health Canada has announced a mandatory date of 2012-06-01. The EU date of 2012-06-01 has been published in the Official Journal. CB Scheme mandatory use for 3rd edition varies per the policy of each member country. Structure of IEC 60601 . General standard Collateral standards (Part 1 standard) IEC 60601 -1-XX.

www.intertek.com Collateral Standards Obsolete standards IEC 60601-1-1 medical systems incorporated (cl. 16) IEC 60601-1-4 Software incorporated (cl. 14)


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