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ANSI/AAMI/ISO TIR10993-20:2006

Current
Current

The latest, up-to-date edition.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 20: PRINCIPLES AND METHODS FOR IMMUNOTOXICOLOGY TESTING OF MEDICAL DEVICES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

09-05-2005

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO/TS 10993-20
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Risk assessment and risk management
5 Identification of hazards
6 Methods of assessment of immunotoxicity
  6.1 General
  6.2 Inflammation
  6.3 Immunosuppression
  6.4 Immunostimulation
  6.5 Hypersensitivity
  6.6 Auto-immunity
7 Extrapolation of data provided by pre-clinical assays
Annex A (informative) Current state of knowledge
Annex B (informative) Clinical experience with medical
        devices
Annex C (informative) Flow chart for immunotoxicity testing
Bibliography

Gives an overview of immunotoxicology with particular reference to the potential immunotoxicity of medical devices.

Committee
WG 07
DocumentType
Standard
ISBN
1570202680
Pages
33
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
SupersededBy

Standards Relationship
ISO/TS 10993-20:2006 Identical

AAMI TIR17 : 2008 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
AAMI TIR17 : 2017 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION

ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
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
ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation

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