Name: AAMI ISO 10993-13:2010
Brand: AAMI

AAMI ISO 10993-13:2010

Superseded

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES

Available format(s)

Hardcopy , PDF

Superseded date

25-01-2020

Language(s)

English

Published date

01-01-2014

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 10993-13:2010
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Degradation test methods
5 Test procedures
6 Test report
Annex A (informative) - Analytical methods
Annex B (informative) - Environmental stress cracking
(ESC) of polymers
Bibliography

Gives 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	WG 02
DocumentType	Standard
Pages	28
ProductNote	Reconfirmed 2010
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Superseded
SupersededBy	ANSI/AAMI/ISO 10993-13:2010(R2014)
Supersedes	AAMI ISO 10993-13 : 1999

Standards	Relationship
ISO 10993-13:2010	Identical

ISO 13781:2017	Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
ISO 10993-12:2012	Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-17:2002	Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 10993-9:2009	Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ISO 3696:1987	Water for analytical laboratory use — Specification and test methods
ISO 14971:2007	Medical devices Application of risk management to medical devices