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AAMI 10993 3 2014

AAMI 10993 3 2014

$75.64

ANSI/AAMI/ISO 10993-3:2014 – Biological evaluation of medical devices-Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity

Published By Publication Date Number of Pages
AAMI 2014 50
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Specifies strategies for hazard identification and tests on medical devices for genotoxicity, carcinogenicity, and reproductive and developmental toxicity. Applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 10993-3:2014, Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
3 Title page
4 AAMI Standard
Copyright information
5 Contents
7 Glossary of equivalent standards
8 Committee representation
10 Background of ANSI/AAMI adoption of ISO 10993-3:2014
11 Foreword
13 Introduction
Introduction
15 1 Scope
2 Normative references
16 3 Terms and definitions
4 Requirements for test strategies
4.1 General
17 4.2 Additional requirements for carcinogenicity testing
4.3 Additional requirements for reproductive toxicity testing
18 5 Genotoxicity tests
5.1 General
5.2 Test strategy
5.2.1 General
5.2.2 Test battery
19 5.2.3 Follow-up evaluation
20 5.3 Sample preparation
21 6 Carcinogenicity tests
6.1 General
6.2 Evaluation strategy
22 6.3 Sample preparation
6.4 Test methods
23 7 Reproductive and developmental toxicity tests
7.1 General
7.2 Test strategy
24 7.3 Sample preparation
7.4 Test methods
8 Test report
26 Annex A: Guidance on selecting an appropriate sample preparation procedure in genotoxicity testing
A.1 General
27 A.2 Device materials
A.2.1 Low Molecular Weight Chemicals (LMWC)
A.2.2 Polymers (including naturally occurring polymers)
A.2.2.1 LMWC contained in polymers
A.2.2.2 Oligomers
28 A.2.2.3 Biodegradable polymers
A.2.3 Inorganic materials: Wear debris from metals, alloys and ceramics
A.3 Sample Preparation Methods
A.3.1 General
29 Figure A.1 — Structured approach to select a sample preparation procedure
30 Table A.1 — Common extraction solvents
A.3.2 Method A
A.3.3 Method B
A.3.3.1 General
31 A.3.3.2 Test sample preparation
A.3.3.3 Procedure
32 A.3.3.4 Expression of results
A.3.4 Method C
A.3.4.1 General
A.3.4.2 Procedure
33 A.4 Additional guidance on special sample preparation procedures
A.4.1 Biodegradable polymers
A.4.2 Inorganic materials: Wear debris from metals, alloys and ceramics
A.4.3 LMWC
34 Annex B: Flowchart for follow-up evaluation
Figure B.1 — Flowchart for follow-up evaluation
35 Annex C: Rationale of test systems
C.1 Genotoxicity tests
36 C.2 Carcinogenicity tests
C.3 Reproductive/developmental toxicity tests
37 Annex D: Cell transformation test systems
38 Annex E: Considerations for carcinogenicity studies performed as implantation studies
E.1 Foreign body carcinogenesis
E.2 Animal welfare considerations
39 Annex F: In vitro tests for embryo toxicity
Table F.1 — Criteria defined by the management team of the study to evaluate test performance
40 Table F.2 — Summary of the classification results (all data[88])
41 Annex ZA: Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical devices
43 Annex ZB: Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices
Table ZB.1 — Correspondence between this European Standard and Directive 90/385/EEC on active implantable medical devices
44 Bibliography

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AAMI 10993 3 2014
$75.64