consolidated version – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Fri, 13 Jul 2012 17:58:23 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png consolidated version – Eisner Safety Consultants https://eisnersafety.com 32 32 Amendment 1 of IEC 60601-1:05 (3rd edition) has been published by IEC https://eisnersafety.com/2012/07/13/amendment-1-of-iec-60601-105-3rd-edition-has-been-published-by-iec/?utm_source=rss&utm_medium=rss&utm_campaign=amendment-1-of-iec-60601-105-3rd-edition-has-been-published-by-iec Fri, 13 Jul 2012 17:58:23 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=2609 On 13 July 2012 IEC formally published the long awaited IEC 60601-1:05 (also known as third edition) Amendment 1 (A1).  It is available on the IEC.ch website’s store.  Refer to my previous post of 11 July announcing the imminent release of A1.  There is some more detail about A1 in that post.

IEC is planning on also issuing an updated consolidated version of IEC 60601-1:05 which will include Interpretation Sheets 1 & 2  (IS 1 & IS2), Corrigendums 1 & 2 (Corr 1 & Corr 2), and A1.  They hope to have this out next week.  The IS 1 & 2 and the Corr 1 & 2 are available free on the IEC.ch website (refer to weblinks 2 sentences prior).

The US national version (AAMI) of A1 is in the works and AAMI is hoping to get the approvals done soon so they can also publish it as a US based Amendment as soon as possible but it may take awhile before it gets published as they didn’t expect IEC to publish the document quite so soon.  They are also planning to issue a consolidated version of the AAMI standard similar to the IEC version plus of course it would include the US National Deviations.

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