Please select and order
€84.27
excl. VAT
Add to cart
Norm
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 f...
Withdrawn: 2018 01 15
Publisher:
Austrian Standards International
Format:
Digital | 20 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
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.
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
Norm
Issue date :
2006 07 06
Biological evaluation of medical devices — Part 2: Animal welfare requirements
Norm
Issue date :
2007 10 31
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (Corrected version 2008-02)
Draft
Issue date :
2010 05 06
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Norm
Issue date :
2002 11 27
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
Norm
Issue date :
2005 06 30
Biological evaluation of medical devices — Part 18: Chemical characterization of materials
Norm
Issue date :
2007 02 28
Medical devices — Application of risk management to medical devices (Corrected version 2007-09)
Norm
Issue date :
2009 10 13
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
Norm
Issue date :
2006 07 06
Biological evaluation of medical devices — Part 2: Animal welfare requirements
Norm
Issue date :
2002 11 27
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
Norm
Issue date :
2020 01 13
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
Norm
Issue date :
2019 12 10
Medical devices — Application of risk management to medical devices
Norm
Issue date :
2018 08 17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)
Norm
Issue date :
2018 01 15
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
Norm
Issue date :
2010 02 09
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
