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AAMI ISO 10993-5 : 2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
Available format(s)

Hardcopy , PDF

Superseded date

08-31-2021

Language(s)

English

Published date

01-01-2014

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 2009
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

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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