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EN ISO 10993-16:2017 Standard

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  Keywords:

#studies #toxicokinetic #degradation #design #study

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

  Purpose

ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

  Publication

Wednesday 14th of April 2021

  Related Standards

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EN 1985:1998

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EN ISO 5366-1:2009

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