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  • 17/30344601 DC : 0

    NA Status of Standard is Unknown

    BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    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 General principles applying to biological evaluation
      of medical devices
    5 Categorization of medical devices
    6 Biocompatibility evaluation process
    7 Interpretation of biological evaluation data and
      overall biological safety assessment
    Annex A (informative) - Endpoints to be addressed
            in a biological risk assessment
    Annex B (informative) - Guidance on the conduct of
            biological evaluation within a risk management
            process
    Annex C (informative) - Suggested procedure for
            literature review
    Annex ZA (informative) - Relationship between this
             European Standard and the essential requirements
             of Directive 93/42/EEC [OJ L 169] aimed to be covered
    Annex ZB (informative) - Relationship between this
             European Standard and the essential requirements
             of Directive 90/385/EEC [OJ L 189] aimed to be covered
    Bibliography

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

    Comment Closes On
    Committee CH/194
    Document Type Draft
    Publisher British Standards Institution
    Status NA

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO/TR 10993-22:2017 Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
    ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
    ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
    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/TR 10993-33:2015 Biological evaluation of medical devices Part 33: Guidance on tests to evaluate genotoxicity Supplement to ISO 10993-3
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
    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 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
    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 9001:2015 Quality management systems — Requirements
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    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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