New IEC 60601-1-11 Edition 2.0 – Homecare Medical Devices

IEC 60601-1-11, “Medical Electrical Equipment – Part 1-11: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment,” has just been revised.  The new Edition 2.0 is available now from Document Center Inc., an authorized distributor of the IEC standards.  You can purchase your copy in paper format, for pdf download, or as part of our multi-user Standards Online subscription service.

The IEC 60601-1-11 addresses the challenge of safety for devices that are used in an “uncontrolled” (non-clinical) environments.  The major problem is the potential for untrained operators to be controlling medical electrical equipment.  What instructions are most appropriate for this user base?  And what warning markings should be put on the equipment itself?

The standard has been in use since 2010 and this represents the first significant updating of the document.  There are a broad range of revisions and you may want to purchase the redline edition in order to spot all the changes in this new release.  Just ask our staff about the cost when you place your order.

Here’s information on what the primary changes are:

  • The test method for relative humidity has been corrected.
  • A number of subclauses have been re-written to insure that they do not alter IEC 60601-1 or the other relevant collateral standards.
  • The document has been harmonized with various amendments to IEC 60601-1 and it’s other collateral standards.

You’ll find changes throughout the document itself.  The update is technical and extensive.  You’ll want to get your copy of the new document right away if you are using the previous edition.  This is especially true since compliance with this document is a requirement for a number of regulatory jurisdictions, including the U.S., Europe and Canada.  While the adoption of the new edition in these regions may take some time due to administrative procedures, you’ll want to be prepared for the eventual need to meet these new requirements.

So the next question is: “How do I get my copy of the new IEC 60601-1-11?”  Head to Document Center’s webstore at www.document-center.com and order online.  Or contact our staff via phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been an authorized dealer of the IEC standards since the 1990’s.  Make us your Standards Experts!

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Claudia Bach

Claudia Bach is the President of Document Center Inc. and a world-wide recognized expert on Standards and Standards Distribution. You can connect with her on Google+

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