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UNI EN ISO 10993-5 : 2009

Current
Current

The latest, up-to-date edition.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
Published date

09-17-2009

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

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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