Essential Performance (EP) initially came into the IEC 60601 series of standards when the 3rd edition of IEC 60601-1:2005 was published. The definition was quite confusing and many manufacturers, regulators and test houses had a hard time with it and how to apply it properly. In 3rd edition (2005) + amendment 1 (2012) some clarification came into play which made it easier to understand but there is still a fair amount of confusion.
AS/NZS IEC 60601.1:2015 (Edition 3.1) Just Published
Just Published on 23 Sept 2015 the Australian / New Zealand Joint Standard AS/NZS IEC 60601.1:2015 which is based on the complete IEC 60601-1, edition 3.1:2012 (identical). The only differences are in the AS/NZS IEC 60601-1:2015 the preface states to a) replace the international
CAN/CSA C22.2 No. 60601 Standard Changes
Reminder post – withdrawal of CAN/CSA C22.2 No. 601.1-M90+A1+A2 is on June 30, 2014 & CAN/CSA-C22.2 No. 60601-1:14 was recently published
CAN/CSA C22.2 No. 60601-1:14 (Harmonized with Ed. 3.1) Recently Released
This blog reviews the release of Canadian Standard CAN/CSA C22.2 No. 60601-1:14 & where accessible (Safety Test Agencies vs Health Canada) Recently Released CAN/CSA C22.2 No. 60601-1:14
Leo Eisner Track Chair at MD&M West Conf 11-Feb Discuss EN ISO 14971:2012
UBM Canon Communications has graciously asked me to join this year’s MD&M West Conference with the honor of being the track chair for the Risk, Quality & Validation track on Tues 11 Feb 2014. We have a great line up that day