New Edition 2.0 for IEC 61010-2-101

IEC 61010-2-101, “Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment,” has just been updated.  The new Edition 2.0 is an extensive revision of the original Edition 1.0 from 2002.  Document Center has it available in paper format, for pdf download or as part of our multi-user Standards Online subscription service.  A redline edition is also available to assist you with your gap analysis.

The document itself applies to equipment intended for in vitro diagnostic (IVD) medical purposes.  This includes self-test IVD’s (equipment used by lay persons in a home environment.)  It contains a series of tests as well as other information.  You’ll find information on marking and documentation as well as the kinds of hazards the user needs protection from.  Risk assessment is also addressed.

Let’s discuss some of the changes you’ll find in this new edition of the IEC 61010-2-101.  First, general laboratory equipment has been excluded from the scope of the document.  This means that you’ll use IEC 61010-2-081 for general laboratory equipment and IEC 61010-2-101 for IVD equipment only. NOTE:  The IEC 61010-2-081 has also just been revised.

Requirements have been added to the following Clauses:

  • Clause 5 (in numerous areas)
  • Clause 7
  • Clause 8
  • Clause 13
  • Clause 15
  • Clause 16
  • Clause 17

Other changes include the deletion of Annex BB Instructions for use for self-testing IVD Medical Equipment (a reference is given to ISO 18113-5 in Clause 5.)  And Table 1 in Clause 5 has been updated with Biohazard and Lot symbols.

When you’re faced with so many areas of a standard that have been changed, the use of the redline edition can make the task of identifying critical updates much easier.  Since the two documents have already been compared to create the marked-up copy of the previous edition, every modification is there “in black-and-white.”  Or perhaps I should say in black and red!

Now you need your copy of the new update.  Go directly to Document Center’s website at www.document-center.com to place your order.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been providing folks like you with standards since 1982.  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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