Amendment 1 IEC 60601-1 3rd ed. – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Wed, 11 Jul 2012 02:40:48 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png Amendment 1 IEC 60601-1 3rd ed. – Eisner Safety Consultants https://eisnersafety.com 32 32 Publication of IEC 60601-1, 3rd ed. Amendment 1 Imminent https://eisnersafety.com/2012/07/11/publication-of-iec-60601-1-3rd-ed-amendment-1-imminent/?utm_source=rss&utm_medium=rss&utm_campaign=publication-of-iec-60601-1-3rd-ed-amendment-1-imminent Wed, 11 Jul 2012 02:40:48 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=2583 It has been a bit more than 4 years since the A1 project was approved and initiated.  The vote on Amendment 1 (A1) of IEC 60601-1, third edition project ended on 2 July 2012 and it was a resounding unanimous positive vote of the National Committees to publish the much needed and long awaited A1.  A lot of the changes were for clarifications or editorial changes but some of the changes were technical in nature to modify test requirements among others areas of concern. The Amendment 1 to IEC 60601-1, third edition will be published by IEC within the next few days to the end of the month. 

A1 addresses 182 issues that have been identified by various interested parties starting prior to the end of the development process of IEC 60601-1, 3rd edition which was published December 2005.  The initial comments that were brought into the A1 project were initiated during the FDIS (Final Draft International Standard) stage of IEC 60601-1, 3rd edition.   Through the A1 process there have been 496 separate changes made to the standard (third edition).  There is a potential Technical Report document that is being discussed and voted on by the National Committees for IEC SC 62A the sub-committee on ‘Common aspects of electrical equipment used in medical practice’, which is in charge of the standard IEC 60601-1 among other standards and technical reports in the IEC 60601-1 series.  This document, if approved, will help users of A1 in assessing the impact of the most significant changes to A1:2012.   In this draft Technical Report state it has identified 83 changes of moderate or significant impact on the user of the standard.  In its’ present state the draft Technical Report also breaks up the impact analysis of the changes into Impact on ‘Many Users’ vs ‘Particular Users’ (a smaller subset of ‘Users’ of the standard).  As this draft Technical Report develops more news will be issued.

If you have any questions in regard to IEC 60601-1 and it’s series of Standards and Technical Reports Eisner Safety Consultants is here to support you in your efforts of meeting and maintaining compliance with applicable Standards.  Please feel free to contact us at Leo@EisnerSafety.com.

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