IEC 60601-2-2 Edition 6.0 – High Frequency Surgical Equipment

IEC 60601-2-2 has just been updated.  It is titled Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.  The new Edition 6.0 replaces the previous Edition 5.0 from 2009.  It is a technical update.

Electrosurgery is widely used as a methodology for preventing blood loss.  Tissue is heated using rapidly alternating current in order to halt bleeding.  So a wide variety of surgical equipment and accessories will use this application.

IEC 60601-2-2 deals with the minimum safety requirements for these devices.  It is to be used in conjunction with IEC 60601-1 (and it’s Amendment 1).  The IEC 60601-2-2 has various clauses and subclauses that may replace, add to, or amend the clauses of the 60601-1.  So you need to use both documents together in order to correctly understand the 60601-2-2.

For those of you already using the standard, one of your first questions will be “What are the changes in the new IEC 60601-2-2 Edition 6.0?”  In the foreward  to the publication, IEC Committee 62 directs your attention to the following significant areas of change:

  • The defined terms have been updated, including new additions.
  • Requirements for HF surgical equipment and HF surgical accessories have been given additional separation.
  • Adult neutral electrodes are now required to be contact quality monitoring neutral electrodes.
  • Devices that have a high current mode (or use one) have new requirements.

A significant portion of the IEC 60601-2-2 is devoted to the 2 Annexes.  Annex AA contains additional information on specific clauses and subclauses.  An asterisk will identify items with explanatory notes in the annex.  Annex BB covers electromagnetic disturbances caused by this type of equipment.  This can be useful to medical device manufacturers who need to know what kinds of emissions (and levels) will be generated by HF surgical equipment.  In addition, tests for resistance to this type of emissions are included in the Annex.

All users of IEC standards need to purchase their copies from authorized distributors like Document Center Inc.  Search for and order IEC standards with confidence at our webstore, www.document-center.com.  Here is a direct link to the order page for IEC 60601-2-2.  You’ll have the option to choose either paper format or pdf download when you place your order.

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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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