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

Standard No.

ANSI/AAMI/ISO 10993-16:1997

Release Date

1997

Published By

American National Standards Institute （ANSI)

Status

Be replaced

Replace By

ANSI/AAMI/ISO 10993-16:2017

Latest

ANSI/AAMI/ISO 10993-16:2017

Scope

Gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed.

ANSI/AAMI/ISO 10993-16:1997 history

• 2020 ANSI/AAMI/ISO 10993-16:2017 Biological evaluation of medical devices-Part 16: Toxicokinetic study design for degradation products and leachables
• 1997 ANSI/AAMI/ISO 10993-16:1997 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables