AAMI ISO 10993-10 : 2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
English
01-01-2014
31-08-2021
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 10993-10:2010
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles - Step-wise approach
5 Pretest considerations
6 Irritation tests
7 Skin sensitization tests
8 Key factors in interpretation of test results
Annex A (normative) - Preparation of materials for
irritation/sensitization testing
Annex B (normative) - Special irritation tests
Annex C (normative) - Human skin irritation test
Annex D (informative) - In vitro tests for skin irritation
Annex E (informative) - Method for the preparation of extracts
from polymeric test materials
Annex F (informative) - Background information
Bibliography
Specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
| Committee |
WG 08
|
| DevelopmentNote |
Supersedes AAMI BE78 and AMD 1 TO AAMI BE78. (10/2010)
|
| DocumentType |
Standard
|
| Pages |
88
|
| ProductNote |
Reconfirmed 2010
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 10993-10:2010 | Identical |