AAMI ISO 10993-9 : 2009

Name: AAMI ISO 10993-9 : 2009
Brand: AAMI

Superseded

View Superseded by

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS

Available format(s)

Hardcopy , PDF

Superseded date

31-08-2021

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 10993-9:2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for design of degradation studies
5 Study report
Annex A (normative) - Consideration of the need for
degradation studies
Annex B (informative) - Biodegradation study
considerations
Bibliography

Gives general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies.

Committee	WG 02
DocumentType	Standard
Pages	22
ProductNote	Reconfirmed 2009
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Superseded
SupersededBy	ANSI/AAMI/ISO 10993-9:2009(R2014)
Supersedes	AAMI ISO 10993-9 : 1999

Standards	Relationship
ISO 10993-9:2009	Identical

ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
ISO 10993-13:2010	Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10271:2011	Dentistry Corrosion test methods for metallic materials
ISO 10993-2:2006	Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-14:2001	Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
ISO 13781:2017	Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process