BS EN ISO 10993-16:1997
Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables

Standard No.

BS EN ISO 10993-16:1997

Release Date

1997

Published By

British Standards Institution (BSI)

Status

Be replaced 2010-03

Replace By

BS EN ISO 10993-16:2009

BS EN ISO 10993-16:2010

Latest

BS EN ISO 10993-16:2017(2020)

Scope

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.

BS EN ISO 10993-16:1997 history

• 0000 BS EN ISO 10993-16:2017(2020)
• 2020 BS EN ISO 10993-16:2017 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
• 2010 BS EN ISO 10993-16:2010 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
• 0000 BS EN ISO 10993-16:2009
• 1997 BS EN ISO 10993-16:1997 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables