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PD ISO/TR 15499:2016

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

01-31-2017

Publisher

British Standards Institution

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.

This document is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO10993-1. It does not add to, or otherwise change, the requirements of ISO10993-1. This document does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.

This guidance is applicable to all biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.

Committee
CH/194
DocumentType
Standard
Pages
26
PublisherName
British Standards Institution
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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Hardcopy - English
PDF - English
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