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  • DIN EN ISO 10993-1:2010-04

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009)

    Available format(s):  Hardcopy, PDF

    Superseded date:  29-04-2021

    Language(s):  English, German

    Published date:  01-04-2010

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    Development Note Supersedes DIN EN 30993-1. (05/2002) DRAFT 2017 issued in April 2017. (04/2017)
    Document Type Standard
    Product Note Supersedes DIN EN 30993-1. (SHM 05/2002) DRAFT 2017 issued in April 2017; price: 148.60 Euro. (Sukh 04/2017)
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    Supersedes

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

    DIN EN ISO 10993-6:2009-08 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    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
    DIN EN ISO 10993-2:2006-10 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
    DIN EN ISO 10993-7:2009-02 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
    ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
    DIN EN ISO 10993-11:2015-12 (Draft) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    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
    DIN EN ISO 10993-15:2009-10 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
    DIN EN ISO 10993-16:2016-04 (Draft) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES (ISO 10993-16:2017)
    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
    DIN EN ISO 10993-5:2009-10 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
    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
    DIN EN ISO 10993-12:2012-10 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    DIN EN ISO 10993-4:2016-02 (Draft) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:2017)
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    DIN EN ISO 10993-18:2009-08 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009
    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
    DIN EN ISO 10993-10:2014-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
    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
    DIN EN ISO 10993-17:2009-08 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
    DIN EN ISO 10993-14:2009-08 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
    DIN EN ISO 10993-9:2010-04 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
    DIN EN ISO 10993-3:2015-02 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY (ISO 10993-3:2014)
    DIN EN ISO 10993-13:2010-11 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
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