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.
Dates of withdrawal of national standards are available from NSAI.
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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
Specifies test methods to assess the in vitro cytotoxicity of medical devices.
| DevelopmentNote |
Supersedes I.S. EN 30993-5. (05/2007)
|
| DocumentType |
Standard
|
| Pages |
50
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 10993-5 : 2010 | Identical |
| NEN EN ISO 10993-5 : 2009 | Identical |
| NS EN ISO 10993-5 : 2009 | Identical |
| UNI EN ISO 10993-5 : 2009 | Identical |
| UNE-EN ISO 10993-5:2009 | Identical |
| SN EN ISO 10993-5:2009 | Identical |
| DIN EN ISO 10993-5:2009-10 | Identical |
| EN ISO 10993-5:2009 | Identical |
| NBN EN ISO 10993-5 : 2009 | Identical |
| BS EN ISO 10993-5:2009 | Identical |
| ISO 10993-5:2009 | Identical |
| 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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