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ANSI/AAMI/ISO 10993-3:2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY
Available format(s)

Hardcopy , PDF

Superseded date

11-04-2023

Language(s)

English

Published date

08-14-2014

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of
ISO 10993-3:2014
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for test strategies
5 Genotoxicity tests
6 Carcinogenicity tests
7 Reproductive and developmental toxicity tests
8 Test report
Annex A (informative) - Guidance on selecting an appropriate
        sample preparation procedure in genotoxicity testing
Annex B (informative) - Flowchart for follow-up evaluation
Annex C (informative) - Rationale of test systems
Annex D (informative) - Cell transformation test systems
Annex E (normative) - Considerations for carcinogenicity
        studies performed as implantation studies
Annex F (informative) - In vitro tests for embryo toxicity
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42 EEC on medical devices
Annex ZB (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 90/385/EEC on active implantable
         medical devices
Bibliography

Defines strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices: - genotoxicity; - carcinogenicity; - reproductive and developmental toxicity.

Committee
WG 06
DocumentType
Standard
ISBN
1-57020-561-2
Pages
50
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 10993-3:2014 Identical

AAMI TIR14 : 2016 CONTRACT STERILIZATION USING ETHYLENE OXIDE
ANSI Z80.7 : 2013 OPHTHALMIC OPTICS - INTRAOCULAR LENSES
AAMI TIR17 : 2017 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
AAMI TIR17 : 2008 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION

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
ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation

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