ANSI/AAMI/ISO 10993-9:2009(R2014)
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
Hardcopy , PDF
English
09-23-2014
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
|
| ISBN |
1-57020-384-9
|
| Pages |
22
|
| ProductNote |
Reconfirmed 2014
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| 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 |
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