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EN ISO 10993-16:2017 Standard

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  Keywords:

#studies #toxicokinetic #degradation #design #study

  Directive

Active implantable medical devices Directive (90/385/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

EN ISO 10993-18:2020

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management...

EN ISO 10993-9:2009

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation produc...

EN 60601-1-6:2010

Active implantable medical devices Directive (90/385/EEC)

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Us...

EN ISO 13408-7:2015

Active implantable medical devices Directive (90/385/EEC)

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

EN ISO 13408-4:2011

Active implantable medical devices Directive (90/385/EEC)

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

EN ISO 14155:2020

Active implantable medical devices Directive (90/385/EEC)

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

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