ISO 10993-16:2017
ISO 10993-16:2017

ISO 10993-16:2017

May 2017
International standard Current

Biological evaluation of medical devices - Part 16 : toxicokinetic study design for degradation products and leachables

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.

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Main informations

Collections

International ISO standards

Publication date

May 2017

Number of pages

13 p.

Reference

ISO 10993-16:2017

ICS Codes

11.100.20   Biological evaluation of medical devices

Print number

1
Sumary
Biological evaluation of medical devices - Part 16 : toxicokinetic study design for degradation products and leachables

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.

Replaced standards (1)
ISO 10993-16:2010
ISO 10993-16:2010
February 2010
International standard Cancelled
Biological evaluation of medical devices - Part 16 : toxicokinetic study design for degradation products and leachables

ISO 10993-16:2010 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.

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