Tag: IEC 60601-1 Edition 3.0

New Corrigendum 1 (correction sheet) issued for IEC 60601-1 Edition 3.1 consolidated standard on Medical Electrical Equipment

For those of you who use the IEC 60601-1, “Medical electrical equipment – Part 1: General requirements for basic safety and essential performance,” there’s a newly issued correction sheet for the consolidated Edition 3.1 and it’s available now from Document Center Inc.  FYI: The Edition 3.1 is an interfiled printing of the 3rd Edition with Amendment 1.  The standard is the overview document for the IEC 60601 series on Medical Electrical Equipment.

The Corrigendum 1 is a 2 page correction for Section 7.9.3.  It involves changes for 3 symbols, all found in Table D.2 on Safety signs.  The Corrigendum includes both the original symbols and titles and the replacement symbols and titles for the 3 rows involved.

You’ll want to have this Corrigendum if you’re using the Edition 3.0 and Amendment 1 separately or using the consolidated Edition 3.1.  The changes involved are pertinent for both formats.

Document Center has been selling IEC standards under license agreement since the 1990’s (territorial restrictions apply).  You’ll find them in both paper and pdf format at our webstore, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We have been assisting our customers with their standards purchases and questions for over 30 years!

New Amendment 1 for IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

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.

All IEC standards are available under license agreement from Document Center Inc. at our website, www.document-center.com.  Or consider contacting us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We can assist you with all your standards questions and requirements.