IEC 60601-1 Edition 3.0 from 2005, “Medical electrical equipment – Part 1: General requirements for basic safety and essential performance,” has just been modified with the release of the IEC 60601-1-am1. This new 236-page Amendment 1 is available from Document Center Inc. now.
Corrections to the third edition of IEC-60601-1 were initiated to address the way in which risk management has been introduced into IEC 60601-1:2005 and the way the concept of essential performance is used in the standard as well. However, in the end a wide range of modifications have made their way into this update.
The Amendment 1 itself is divided into 2 parts — pages 1 to 114 cover the changes to the English language portion of the standard and pages 115 to the end cover corrections to the French language side. The pen-and-ink changes are extensive and cover the document from stem to stern.
I suspect that because of the importance of this standard, we should see an interfiled Edition 3.1 soon. However, so far there are no indications of when such a revision might be available.
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Tags: Amendment 1 - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance, IEC 60601-1, IEC 60601-1 Amendment 1, IEC 60601-1 Edition 3.0, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance