New ISO 8600-4 2nd Edition for Endoscopes

The ISO 8600-4, “Endoscopes – Medical endoscopes and endotherapy devices – Part 4: Determination of maximum width of insertion portion,” has just been revised.  The new 2nd Edition is available from Document Center in either paper format or for pdf download.  The document is one of 7 parts that comprise the ISO 8600 series on Endoscopes.  It updates the 1st Edition which was released in 1997 (and is now obsolete).

The endoscope is an essential tool in the medical device arsenal.  Simply defined, it’s a medical instrument for viewing that is inserted into a natural or surgically created body opening.  Used for examination, diagnosis or therapy itself, these devices usually consist of a rigid or flexible tube, a light source, a lens or video system to see or capture the image from the inserted end of the scope, and an additional channel to deliver medical instruments or manipulators.

It’s the Part 4 of the series that has just been updated, on the maximum width of the insertion portion of the endoscope.   The changes to the 8 page document involve combining the old sections 2 and 3 into a new section 2 on test conditions.  This means that the new edition is now laid out as follows:

  1. Scope
  2. Test conditions (includes test environments and the accuracy of measuring instruments)
  3. Methods of measurement (includes general overview, millimeter indication, and french size indication).

Figures 1 and 2 are still included.

Here’s a complete list of the standards in the series, as well as their issue dates so you can confirm you’ve got the latest editions:

  • ISO 8600-1, 2013 Edition, Endoscopes – Medical endoscopes and endotherapy devices – Part 1: General requirements
  • ISO 8600-2, 2002 Edition, Optics and Optical Instruments – Medical Endoscopes and Endoscopic Accessories – Part 2: Particular Requirements for Rigid Bronchoscopes
  • ISO 8600-3, 1997 Edition with Amendment 1 from 2003, Optics and Optical Instruments — Medical Endoscopes and Endoscopic Accessories — Part 3: Determination of Field of View and Direction of View of Endoscopes With Optics
  • ISO 8600-4, 2014 Edition, Endoscopes – Medical endoscopes and endotherapy devices – Part 4: Determination of maximum width of insertion portion
  • ISO 8600-5, 2005 Edition, Optics and Photonics – Medical Endoscopes and Endotherapy Devices – Part 5: Determination of Optical Resolution of Rigid Endoscopes With Optics
  • ISO 8600-6, 2005 Edition, Optics and Photonics – Medical Endoscopes and Endotherapy Devices – Part 6: Vocabulary
  • ISO 8600-7, 2012 Edition, Endoscopes – Medical endoscopes and endotherapy devices – Part 7: Basic requirements for medical endoscopes of water-resistant type

Of course, if you need the any of the ISO 8600 series, you’ll want to purchase your copy from Document Center Inc.  You can do this at our webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  It’s essential that you discover those standards that could impact your business, and maintain those that you reference in your documentation.  That’s why we have a wide range of products and services to help you with this task.  We help many companies around the world with their standardization requirements.  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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