ISO 17664 Updated – Medical Device Sterilization Instructions

ISO 17664 has just been updated.  The new title of this 2nd Edition is Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices.  Previously, it focused on Sterilization of medical devices so you can see the scope of the standard has been expanded.  The 1st Edition from 2004 is now obsolete.  You’ll need to be using this new update and you can get it now from Document Center Inc.

ISO 17664 provides manufacturers with requirements for the instructions that accompany their medical devices and other health care products.  These instructions center on the processing required to make these products ready for use.  This may include an initial sterilization or other processing.  Or it may be processing needed for the reuse of the product.

This update of the ISO 17664 was generated by technical advances in sterilization technologies.  With products becoming more complex, the techniques to clean them are coming under greater scrutiny.  Comprehensive instructions on processing utilizing available equipment is essential.  Additionally there may be critical requirements during the inspection and testing phase performed after a device is cleansed.

As noted, the 32-page 2nd Edition cancels and replaces the 1st Edition.  It is a technical revision, with an expanded scope.  Now the standard covers devices that need both sterilization (as before) and/or disinfection (added) prior to use.

Document Center Inc. customers have already been notified that the new Edition has been released.  We’re filling orders placed at our webstore,, now.  Here’s a direct link to the order page for ISO-17664:2017 for your convenience.  It’s available in paper format and for pdf download.

All ISO standards are also available as part of our Standards Online cloud access service.  This allows you to set up a subscription for the standards critical to your business in a company-wide environment.  To learn more, check in with us by phone (650-591-7600) or email ( We have been working with standards since 1982 and offer a wide range of products to support your compliance 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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