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  • PD ISO/TR 15499:2016

    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:  31-01-2017

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

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

    Scope - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CH/194
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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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