• There are no items in your cart

11/30212473 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN ISO 10993-3 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY
Available format(s)

Hardcopy , PDF

Superseded date

10-31-2014

Language(s)

English

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) - Rationale of test systems
Annex B (informative) - Cell transformation test
        systems
Annex C (normative) - Considerations for carcinogenicity
        studies performed as implantation studies
Annex D (normative) - Guidance on selecting an
        appropriate sample preparation procedure in
        genotoxicity testing
Annex E (informative) - Tests to evaluate genotoxicity
Annex F (informative) - In vitro tests for embryotoxicity
Bibliography
Annex ZA (informative) - Relationship between this
         International Standard and the Essential
         Requirements of EU Directive 93/42/EC

BS EN ISO 10993-3.

Committee
CH/194
DocumentType
Draft
Pages
80
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

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
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

View more information
US$23.96
Excluding Tax where applicable

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.