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ANSI/AAMI/ISO 10993-2:2006(R2014)

Current

Current

The latest, up-to-date edition.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-10-2014

€132.80
Excluding VAT

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO
10993-2:2006-09-29
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex A (informative) - Rationale for the development
        of this part of ISO 10993
Annex B (informative) - Further suggestions for replacing,
        reducing and refining animal tests
Bibliography

Describes the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices.

Committee
WG 03
DocumentType
Standard
ISBN
1570202710
Pages
29
ProductNote
Reconfirmed 2014
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

Standards Relationship
ISO 10993-2:2006 Identical

ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

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