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AAMI/ISO 10993-16:2020/(R)2022

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 11/06/2020

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Full Description

This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

This third edition cancels and replaces the second edition (ISO 10993-16:2010), which has been technically revised.
 

Product Details

Published:
11/06/2020
ISBN(s):
9781570207785
ANSI:
ANSI Approved
Number of Pages:
20
File Size:
1 file , 400 KB
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. AAMI/ISO 10993-16:2020/(R)2022

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    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

    • Most Recent

  2. AAMI/ISO 10993-16:2010/(R)2014


    Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables

    • Historical Version

  3. AAMI/ISO 10993-16:1997 (R2009)


    Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables from medical devices

    • Historical Version