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EN ISO 10993-17:2009 Standard

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  Keywords:

#part #standards #sources #particular #contact

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 25th of March 2020

  Description:

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

  Purpose

This part of ISO 10993 specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. This part of ISO 10993 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices). Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. This part of ISO 10993 does not address the potential for exposure from such sources.

  Publication

Friday 17th of November 2017

  Reference

This standard superseed the "EN ISO 10993-17:2002"

Anyway is still possible use the "EN ISO 10993-17:2002" until March 21st, 2010

  Related Standards

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EN ISO 11737-1:2006

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EN 60601-2-44:2009

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