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EN ISO 10993-16:2010 Standard

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  Keywords:

#toxicokinetic #studies #degradation #evaluation #considerations

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 25th of March 2020

  Description:

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

  Purpose

This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

  Publication

Friday 17th of November 2017

  Reference

This standard superseed the "EN ISO 10993-16:2009"

Anyway is still possible use the "EN ISO 10993-16:2009" until August 31st, 2010

  Related Standards

EN ISO 14630:2009

Medical devices Directive (93/42/EEC)

Non-active surgical implants - General requirements (ISO 14630:2008)

EN ISO 10993-14:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 1...

EN ISO 10524-3:2006

Medical devices Directive (93/42/EEC)

Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)

EN ISO 10524-4:2008

Medical devices Directive (93/42/EEC)

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

EN ISO 10993-1:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

EN ISO 10993-1:2009/AC:2010

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

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