AAMI ISO 10993-13:2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
Hardcopy , PDF
25-01-2020
English
01-01-2014
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Superseded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 | |
| Supersedes |
| 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 |
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