ANSI/AAMI/ISO 10993-5:2009(R2014)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 5: TESTS FOR IN VITRO CYTOTOXICITY
Hardcopy , PDF
04-11-2023
ANSI/AAMI/ISO 10993-5:2009(R2022)
ANSI/AAMI/ISO 10993-1:2018
English
01-01-2014
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Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 10993-5:2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Sample and control preparation
4.1 General
4.2 Preparation of liquid extracts of material
4.3 Preparation of material for direct-contact tests
4.4 Preparation of controls
5 Cell lines
6 Culture medium
7 Preparation of cell stock culture
8 Test procedures
8.1 Number of replicates
8.2 Test on extracts
8.3 Test by direct contact
8.4 Test by indirect contact
8.5 Determination of cytotoxicity
9 Test report
10 Assessment of results
Annex A (informative) Neutral red uptake (NRU) cytotoxicity
test
Annex B (informative) Colony formation cytotoxicity test
Annex C (informative) MTT cytotoxicity test
Annex D (informative) XTT cytotoxicity test
Bibliography
Specifies test methods to assess the in vitro cytotoxicity of medical devices.
| Committee |
WG 05
|
| DocumentType |
Standard
|
| Pages |
50
|
| ProductNote |
Reconfirmed 2014
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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