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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR CYTOTOXICITY - IN VITRO METHODS
01-05-1999
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.
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | 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 |
| 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 |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.