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Norm

ÖNORM EN ISO 10993-16

Issue date: 1998 03 01

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)

This part of IS0 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations fo...
Withdrawn: 2010 01 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 17 Pages
Language:
German | English
Optionally co-design standards:
This part of IS0 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.
ÖNORM EN ISO 10993-16
2018 01 15
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation produ...
Norm
ÖNORM EN ISO 10993-16
2010 06 15
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation produ...
Norm
ÖNORM EN ISO 10993-16
2009 09 15
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation produ...
Norm
ÖNORM EN ISO 10993-16
1998 03 01
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation produ...
Norm
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Norm
ISO 10993-1:1992
Issue date : 1992 04 23
Biological evaluation of medical devices — Part 1: Guidance on selection of tests
Norm
ÖNORM EN ISO 10993-16
Issue date : 2009 09 15
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)
Norm
ISO 10993-16:1997
Issue date : 1997 08 28
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables