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  • DIN EN ISO 10993-12:2012-10

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 12: Sample preparation and reference materials (ISO 10993-12:2012)

    Available format(s):  Hardcopy, PDF

    Superseded date:  03-08-2021

    Language(s):  English, German

    Published date:  01-10-2012

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

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    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN EN ISO 29701:2011-01 Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010)
    DIN EN ISO 3826-4:2015-12 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
    DIN EN ISO 11979-5:2010-11 Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)
    VDI 5703:2015-09 Systematical development for a model-based testing of medical devices
    DIN EN ISO 3826-1:2013-09 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013)
    DIN EN ISO 11979-6:2015-02 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
    DIN EN ISO 10993-7:2009-02 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
    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 10993-1:2010-04 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009)
    DIN EN ISO 10993-10:2014-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
    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 7405:2013-12 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD. 1:2013)
    DIN EN ISO 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    DIN EN ISO 10993-5:2009-10 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
    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)
    DIN EN ISO 10993-11:2015-12 (Draft) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
    DIN EN ISO 10993-6:2009-08 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)

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

    ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    ISO Guide 33:2015 Reference materials Good practice in using reference materials
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    ISO Guide 35:2017 Reference materials Guidance for characterization and assessment of homogeneity and stability
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO Guide 30:2015 Reference materials Selected terms and definitions
    CFR 40(PTS700-789) : JUL 2016 PROTECTION OF ENVIRONMENT - ENVIRONMENTAL PROTECTION AGENCY
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO Guide 31:2015 Reference materials — Contents of certificates, labels and accompanying documentation
    NFS 90 701 : 1988 MEDICO-SURGICAL EQUIPMENT - BIOCOMPATIBILITY OF MATERIALS AND MEDICAL DEVICES
    ISO Guide 34:2009 General requirements for the competence of reference material producers
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