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AAMI ISO 10993-16 : 2010 : R2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
Available format(s)

Hardcopy , PDF

Superseded date

01-02-2018

Language(s)

English

Published date

01-01-2014

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 10993-16:2010
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for design of toxicokinetic studies
5 Guidance on test methods
Annex A (normative) - Circumstances in which toxicokinetic
        studies shall be considered
Bibliography

Provides principles on how toxicokinetic studies relevant to medical devices should be designed and performed.

Committee
WG 13
DocumentType
Standard
Pages
26
ProductNote
Reconfirmed 2014
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 10993-16:2017 Identical

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 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14971:2007 Medical devices Application of risk management to medical devices

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Hardcopy - English
PDF - English - DRM
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