STANDARD

Withdrawn

ÖNORM EN ISO 10993-16

Issue date: 2010 06 15

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

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.

General information on ÖNORM EN ISO 10993-16

Format
Digital | 20 Pages
Language
German | English | Download GER/ENG
Publisher
Austrian Standards International

Timeline

An overview of the development of ÖNORM EN ISO 10993-16 from 1998 til today.

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer Titel Ausgabedatum Art Link
Dokumentnummer
ISO 10993-1:2018
Titel
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)
Ausgabedatum
2018 08 17
Art
Standard
Dokumentnummer
ISO 10993-17:2002
Titel
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
Ausgabedatum
2002 11 27
Art
Standard
Dokumentnummer
ISO 10993-18:2020
Titel
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
Ausgabedatum
2020 01 13
Art
Standard
Dokumentnummer
ISO 10993-2:2006
Titel
Biological evaluation of medical devices — Part 2: Animal welfare requirements
Ausgabedatum
2006 07 06
Art
Standard
Dokumentnummer
ISO 14971:2019
Titel
Medical devices — Application of risk management to medical devices
Ausgabedatum
2019 12 10
Art
Standard

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