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UNE-EN ISO 10993-3:2015

Current
Current

The latest, up-to-date edition.

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

05-06-2015

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Genotoxicity tests
  4.1 General
  4.2 Test strategy
  4.3 Sample preparation
  4.4 Test methods
      4.4.1 In vitro genotoxicity tests
      4.4.2 In vivo genotoxicity tests
5 Carcinogenicity tests
  5.1 General
  5.2 Test strategy
  5.3 Sample preparation
  5.4 Test methods
6 Reproductive and developmental toxicity tests
  6.1 General
  6.2 Test strategy
  6.3 Sample preparation
  6.4 Test methods
7 Test report
Annex A (informative) Cell transformation test system
Annex B (informative) Rationale of test systems
Annex C (informative) Role of implantation
        carcinogenicity studies
Bibliography

Gives strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity. Applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified. Also provides guidance on selection of tests.

Committee
CTN 111
DevelopmentNote
Supersedes UNE EN 30993-3. (04/2004)
DocumentType
Standard
Pages
48
PublisherName
Asociacion Espanola de Normalizacion
Status
Current
Supersedes

ISO/TR 10993-33:2015 Biological evaluation of medical devices Part 33: Guidance on tests to evaluate genotoxicity Supplement to ISO 10993-3
ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
CFR 40(PTS700-789) : JUL 2016 PROTECTION OF ENVIRONMENT - ENVIRONMENTAL PROTECTION AGENCY
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ASTM C 1439 : 2013 : REDLINE Standard Test Methods for Evaluating Latex and Powder Polymer Modifiers for use in Hydraulic Cement Concrete and Mortar
ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation

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