UPDATE: On 13 July 2012 IEC formally published the long awaited IEC 60601-1:05 (also known as third edition) Amendment 1 (A1). It is on the IEC.ch website’s store. See below for more detail about A1.
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.
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. —Leo Eisner
It has been a bit more than four years since the Amendment 1 (A1) of IEC 60601-1, third edition project was approved and initiated. The vote on the 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 July.
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 that was published December 2005. The initial comments that were brought into the A1 project were initiated during the Final Draft International Standard (FDIS) 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 it’s present state, the draft Technical Report also breaks up the impact analysis of the changes into Impact on ‘Many Users’ versus ‘Particular Users’ (a smaller subset of ‘Users’ of the standard). As this draft Technical Report develops more news will be issued.
Questions regarding IEC 60601-1 and it’s series of Standards and Technical Reports can be sent to Eisner Safety Consultants.
Leo Eisner is the head of Eisner Safety Consultants (Portland, OR), which specializes in product safety, quality systems, and regulatory concerns for the medical device market.