I.S. EN ISO 10993-5:2009
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY (ISO 10993-5:2009)
Hardcopy , PDF
English
01-01-2009
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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
Annex ZA (informative) - Relationship between this International
Standard and the Essential Requirements of EU
Directive 93/42/EEC
Annex ZB (informative) - Relationship between this International
Standard and the Essential Requirements of EU
Directive 90/385/EEC
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