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NF EN 30993-5 : 1994

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

EVALUATION BIOLOGIQUE DES DISPOSITIFS MEDICAUX - : ESSAIS CONCERNANT LA CYTOTOXICITE : METHODE IN VITRO

Superseded date

01-12-1999

Published date

12-01-2013

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. Coverage includes definitions, cell lines, culture medium, and determination of cytotoxicity.

DevelopmentNote
INDICE DE CLASSEMENT: S99505
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Superseded
Supersedes

Standards Relationship
DIN EN 30993-5 E : 1994 Identical
I.S. EN 30993-5:1994 Identical
DIN EN 30993-5:1994-08 Identical
BS EN 30993-5:1994 Identical
EN 30993-5 : 1994 Identical
UNE-EN 30993-5:1995 Identical

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