I.S. EN 30993-5:1994
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - TESTS FOR CYTOTOXICITY - IN VITRO METHODS
Hardcopy , PDF
01-10-1999
English
01-01-1994
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.
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Cooperating organizations
National foreword
Foreword
1. Scope
2. Normative reference
3. Definitions
4. Sample preparation
4.1 General
4.2 Preparation of liquid extracts of material
4.3 Preparation of material for direct contact tests
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. Bibliography
National annex NA (informative) Committees responsible
National annex NB (informative) Cross-reference
Describes test methods to assess the in vitro cytotoxicity of medical devices.
| DocumentType |
Standard
|
| Pages |
50
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN 30993-5 : 1994 | Identical |
| NBN EN 30993-5 : 1994 | Identical |
| UNI EN 30993-5 : 1995 | Identical |
| BS EN 30993-5:1994 | Identical |
| EN 30993-5 : 1994 | Identical |
| UNE-EN 30993-5:1995 | Identical |
| DIN EN 30993-5 E : 1994 | Identical |
| DIN EN 30993-5:1994-08 | Identical |
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