Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

09-10-2023

Publisher

Association for the Advancement of Medical Instrumentation

This part of ISO 10993 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.

Committee	ISO/TC 194
DocumentType	Standard
ISBN	978-1-57020-396-1
Pages	28
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Current
Supersedes	ANSI/AAMI/ISO 10993-13:2010(R2014)

Standards	Relationship
ISO 10993-13:2010	Identical

ISO 14971:2019	Medical devices Application of risk management to medical devices
ISO 13781:2017	Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing

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ANSI/AAMI/ISO 10993-13:2010(R2019)

Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices

Abstract

General Product Information

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