UNI EN ISO 10993-5 : 2009
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
17-09-2009
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
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
Bibliography
Specifies test methods to assess the in vitro cytotoxicity of medical devices.
| Committee |
CT 44
|
| DevelopmentNote |
Supersedes UNI EN 30993-5. (04/2001)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NEN EN ISO 10993-5 : 2009 | Identical |
| NF EN ISO 10993-5 : 2010 | Identical |
| NS EN ISO 10993-5 : 2009 | Identical |
| I.S. 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 |
| UNI 11533 : 2014 | MASS-PRODUCED ORTHOPEDIC FOOTWEAR DESIGNED FOR FOOT ORTHOTIC - SAFETY AND PERFORMANCE REQUIREMENTS AND TEST METHODS |
| 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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