New ISO 8600-1 2015 on Endoscopes

ISO 8600-1, “Endoscopes – Medical endoscopes and endotherapy devices – Part 1: General requirements,” has just been updated.  The new 4th Edition is available now from Document Center Inc.  in a variety of formats, so you can update your copy at any time.  While this new revision is considered a minor update, it still cancels the previous editions, including the 3rd Edition from 2013.

This Part 1 for the ISO 8600 series covers all the basics.  So you’ll get the terms and definitions required for implementing all the other parts.  And basic requirements for endoscopes and endotherapy devices are included.  It’s essential to use this Part 1 in conjunction with the balance of the 7 Parts of the ISO 8600 series.

What is an endoscope?  It’s a medical instrument allowing for viewing either with or without optics (think camera).  It’s introduced into the body via a natural or surgically created opening.  It’s used to examination, diagnosis, or therapy.  There are two main types of endoscopes — Rigid and flexible.  Endotherapy devices are additional medical devices used in conjunction with endoscopes, again for examination, diagnosis or therapy.

What is the primary change to the 4th Edition of ISO 8600-1?  Since it is a minor update, there’s not too much that’s changed.  The main thing is the update to the definition of “field of view” and to the figure 1 that is an example of that definition.

Do you need to purchase a copy of ISO 8600-1?  If you have to meet the requirements of the standard for regulatory or contractual purposes, the new update is a must.  Our web store, www.document-center.com, has copies for you to order in either paper format or for pdf download.  Here’s a link directly to the order page for ISO 8600-1.

Considering a site license?  Our Standards Online subscription service can include this ISO standard.  Contact our staff by phone (650-591-7600) or email (info@document-center.com) for more information.

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New ISO 8600-1 2013 Edition issued for Endoscopes

There’s a new 3rd Edition out for ISO 8600-1, “Endoscopes — Medical endoscopes and endotherapy devices — Part 1: General requirements,” and it’s available now from Document Center Inc.  The widely used Medical Device standard ISO 8600-1:2013 provides the user with definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine.  FYI: The second edition is now obsolete.

There are a total of 7 parts in this series.  The others are:

  • ISO 8600-2, Optics and Optical Instruments – Medical Endoscopes and Endoscopic Accessories – Part 2: Particular Requirements for Rigid Bronchoscopes
  • ISO 8600-3, 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, Optics and Optical Instruments — Medical Endoscopes and Certain Accessories — Part 4: Determination of Maximum Width of Insertion Portion
  • ISO 8600-5, Optics and Photonics – Medical Endoscopes and Endotherapy Devices – Part 5: Determination of Optical Resolution of Rigid Endoscopes With Optics
  • ISO 8600-6, Optics and Photonics – Medical Endoscopes and Endotherapy Devices – Part 6: Vocabulary, and
  • ISO 8600-7, Endoscopes – Medical Endoscopes and Endotherapy Devices – Part 7: Basic Requirements for Medical Endoscopes of Water-Resistant Type

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New ISO 8600-7 2012 1st Edition released for Endoscopes – Medical endoscopes and endotherapy devices – Part 7: Basic requirements for medical endoscopes of water-resistant type

ISO has just released the new ISO 8600-7:2012, “Endoscopes – Medical endoscopes and endotherapy devices – Part 7: Basic requirements for medical endoscopes of water-resistant type,” and it is available now from Document Center Inc.   This part of ISO 8600 specifies requirements for medical endoscopes, either flexible or rigid with a bending section, of the water-resistant type.

The new 6-page ISO 8600-7 is part of the ISO 8600 series, which defines terms and gives requirements for endoscopes and endotherapy devices used in the practice of medicine.

The other documents that comprise this series are:

—  ISO-8600-1:2005, Optics and photonics — Medical endoscopes and endotherapy devices — Part 1: General requirements,
ISO-8600-2:2002, Optics and optical instruments — Medical endoscopes and endoscopic accessories — Part 2: Particular requirements for rigid bronchoscopes,
ISO-8600-3:1997 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-8600-4:1997, Optics and optical instruments — Medical endoscopes and certain accessories — Part 4: Determination of maximum width of insertion portion,
ISO-8600-5:2005, Optics and photonics — Medical endoscopes and endotherapy devices — Part 5: Determination of optical resolution of rigid endoscopes with optics and
ISO-8600-6:2005, Optics and photonics — Medical endoscopes and endotherapy devices — Part 6: Vocabulary.

All current ISO standards and many obsolete versions are available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We offer standards sales and support to the medical device industry, providing a wide range of documentation not available from other standards organizations.