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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

Friday 17th of November 2017

  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 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 10993-11:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

EN ISO 9360-1:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HME...

EN ISO 10524-1:2006

Medical devices Directive (93/42/EEC)

Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (I...

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)

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