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  • EN ISO 10993-12:2012

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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): 

    Superseded date:  26-06-2021

    Language(s): 

    Published date:  01-07-2012

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Reference materials (RMs)
    6 Use of RMs as experimental controls
    7 Test sample selection
    8 Test sample and RM preparation
    9 Selection of representative portions from a device
    10 Preparation of extracts of samples
    11 Records
    Annex A (informative) - Experimental controls
    Annex B (informative) - General principles on, and practices of,
            test sample preparation and sample selection
    Annex C (informative) - Principles of test sample extraction
    Annex D (informative) - Exhaustive extraction of polymeric
            materials for biological evaluation
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU Directive
             93/42/EEC on medical devices
    Annex ZB (informative) - Relationship between this European
             Standard and the Essential Requirements of EU Directive
             90/385/EEC on active implantable medical devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO 10993-12:2012 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically, ISO 10993-12:2012 addresses the following:test sample selection; selection of representative portions from a device; test sample preparation; experimental controls; selection of, and requirements for, reference materials; preparation of extracts. ISO 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.

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

    Committee CEN/TC 206
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

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

    I.S. EN ISO 7198:2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016)
    EN 12011 : 1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    VDI 5703:2015-09 Systematical development for a model-based testing of medical devices
    BS EN ISO 10993-6:2016 Biological evaluation of medical devices Tests for local effects after implantation
    I.S. EN ISO 10993-6:2016 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
    I.S. EN ISO 10993-8:2000 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 8: SELECTION AND QUALIFICATION OF REFERENCE MATERIALS FOR BIOLOGICAL TESTS
    I.S. EN 12442-1:2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
    BS EN 12442-1:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk
    EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
    BS EN ISO 25539-1:2017 Cardiovascular implants. Endovascular devices Endovascular prostheses
    I.S. EN 12011:1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    I.S. EN ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
    BS EN 12011:1998 Instrumentation to be used in association with non-active surgical implants. General requirements
    EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
    EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
    EN ISO 10993-8 : 2000 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 8: SELECTION AND QUALIFICATION OF REFERENCE MATERIALS FOR BIOLOGICAL TESTS
    BS EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches
    BS EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components Aphaeresis blood bag systems with integrated features
    I.S. EN ISO 3826-4:2015 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
    UNE-EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
    BS EN 13503-5:2001 Ophthalmic implants. Intraocular lenses Biocompatibility
    ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features
    EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK

    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
    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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