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 standards references with references to Australian or Australian / New Zealand Standards, b) replace in the source text ‘this international standard’ by ‘this Australian/New Zeland Standard’, c) a full point substitues for a comma when refeering to a decimal marker.

If you need help with AS/NZS IEC 60601-1:2015 or IEC 60601-1, 3rd edition or edition 3.1 please email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

If you need additional support for IEC 60601-1, 3rd edition + A1 email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

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.

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.

On October 1, 2011 the DRAFT “FAQ related to Implementation of EN 60601-1:2006 Clarification of open issues” was issued and this DRAFT document is being sent to NB-MED for commenting on the document.  NB-MED is also known as TEAM NB.  This organization is the European Association of Notified Bodies for Medical Devices which covers the MDD (93/42/EEC), AIMDD (90/385/EEC), and IVDD (98/79/EC).  This group publishes guidances that are agreed on by the Medical Device Directives (93/42/EEC, 90/385/EEC, and 98/79/EC) Notified Bodies. Once all the responses are agreed to it is anticipated that the document will be released as an NB-MED guidance document.

The History of this DRAFT document is restated below.  Note that any “click here” links are not live in the below text but are live in the actual DRAFT document.

History

During spring 2011, it was realized that the use of EN 60601-1 and its many family members in demonstrating compliance with the relevant and applicable requirements of the European medical device regulatory framework was not too trivial. While relevant guidance on the matter had been published at the CENELEC website as a Q&A document (click here), some Notified Bodies were giving advice that was felt to be not in line with that guidance. On other occasions, questions were raised that were not covered in the guidance.

So, it was concluded that the situation for electrical equipment in medical practice was not totally clear and that additional guidance would be useful. Further contact with the chair of the NB-MED confirmed this desirability, and a small group of experts was established. This group developed an enquiry asking for “practical issues in the implementation”, that was sent to many stakeholders in June 2011(see Annex 1). Also at the international level of IEC the request was distributed (62A/769/INF).

The response to the request was beyond expectation and the small team of experts, initially consisting of three, was expanded with Dr. Klaus Neuder of DKE (Frankfurt, Germany).

End of July 2011, the work on digesting the issues submitted until then started and it took until end of September 2011 until all material had been thoroughly discussed and answers formulated to the questions that were raised. In some cases, the questions were slightly amended to make them a little more general, and a few additional “connecting” questions were developed by the team.

It is believed that the answers, developed in close team cooperation, present a fair response to the issues brought forward and that they can be used as a reference for all stakeholders.

Now it is time for the NB-MED to scrutinize the proposed responses and see if they are also acceptable to all members of NB-MED. The NB-MED comments are kindly awaited by the end of October 2011, at the same e-mail address that was used for the initial submission of the issues: 60601Ed3.NBMED.issues@gmail.com, using the form supplied together with this document.

Happy reading!

The 60601-1 Issues Team:

Dr. Wolfgang Leetz, Dr. Peter Linders Dr. Klaus Neuder Mr. Martin Schneeberg