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Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR CYTOTOXICITY - IN VITRO METHODS

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Superseded date: 01-05-1999

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Published date: 12-01-2013

Publisher: Comite Europeen de Normalisation

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Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

Describes test methods to assess the in vitro cytotoxicity of medical devices. Coverage includes definitions, cell lines, culture medium, and determination of cytotoxicity.

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Document Type	Standard
ISBN
Pages
Published
Publisher	Comite Europeen de Normalisation
Status	Superseded
Superseded By	EN ISO 10993-5:2009

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Equivalent Standard(s)	Relationship
I.S. EN 30993-5:1994	Identical
NF EN 30993-5 : 1994	Identical
NBN EN 30993-5 : 1994	Identical
UNI EN 30993-5 : 1995	Identical
BS EN 30993-5:1994	Identical
NEN ISO 10993-5 : 1994	Identical
UNE-EN 30993-5:1995	Identical
DIN EN 30993-5 E : 1994	Identical
DIN EN 30993-5:1994-08	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

EN 12011 : 1998	INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
I.S. EN 12011:1998	INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
BS EN 12011:1998	Instrumentation to be used in association with non-active surgical implants. General requirements

Standards Referencing This Book - (Show below) - (Hide below)

ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

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