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AAMI/ISO TIR15499:2017

Current
Current

The latest, up-to-date edition.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON THE CONDUCT OF BIOLOGICAL EVALUATION WITHIN A RISK MANAGEMENT PROCESS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

27-08-2017

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of
 ISO/TR 15499:2016
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Biological evaluation as a risk
  management practice
5 Guidance on risk management
6 Guidance on specific aspects of
  biological evaluation
Bibliography

Pertains to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1.

Committee
TC 194
DocumentType
Technical Report
ISBN
978-1-57020-686-3
Pages
26
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

Standards Relationship
ISO/TR 15499:2016 Identical

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
ISO 10993-13:2010 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 10993-14:2001 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
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 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ISO 14971:2007 Medical devices Application of risk management to medical devices

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