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  • EN ISO 10993-10:2013

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)

    Available format(s): 

    Withdrawn date:  28-02-2014

    Language(s): 

    Published date:  21-08-2013

    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 principles - Step-wise approach
    5 Pretest considerations
    6 Irritation tests
    7 Skin sensitization tests
    8 Key factors in interpretation of test results
    Annex A (normative) - Preparation of materials for
            irritation/sensitization testing
    Annex B (normative) - Special irritation tests
    Annex C (normative) - Human skin irritation test
    Annex D (informative) - In vitro tests for skin irritation
    Annex E (informative) - Method for the preparation of extracts
            from polymeric test materials
    Annex F (informative) - Background information
    Bibliography
    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

    Abstract - (Show below) - (Hide below)

    ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.ISO 10993-10:2010 includes:pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;details of in vivo (irritation and sensitization) test procedures;key factors for the interpretation of the results.Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.

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

    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Withdrawn

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

    15/30278540 DC : 0 BS ISO 18562-4 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 4: TESTS FOR LEACHABLES IN CONDENSATE
    17/30358658 DC : 0 BS EN 13795-1 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS
    17/30358661 DC : 0 BS EN 13795-2 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS
    UNI EN 14683 : 2014 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
    BS EN 455-3:2015 Medical gloves for single use Requirements and testing for biological evaluation
    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
    UNE-EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
    PREN 14683 : DRAFT 2017 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
    PREN 13795-1 : DRAFT 2017 SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS
    13/30281504 DC : 0 BS EN 455-3 - MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
    DIN EN 14683 E : 2014 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
    I.S. EN ISO 4074:2015 NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015)
    VDI 3823 Blatt 4:2006-11 Vacuum coating quality assurance - Testing of vacuum coated plastics
    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
    DIN EN 14683:2014-07 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
    CEN/TR 16953:2017 Medical gloves for single use - Guidance for selection
    DIN EN 455-3:2015-07 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
    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)
    S.R. CEN/TR 16953:2017 MEDICAL GLOVES FOR SINGLE USE - GUIDANCE FOR SELECTION
    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
    PREN 455-3 : DRAFT 2013 MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
    BS EN 14683:2014 Medical face masks. Requirements and test methods
    I.S. EN ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
    PD CEN/TR 16953:2017 Medical gloves for single use. Guidance for selection
    17/30359567 DC : 0 BS EN 14683 - MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
    EN 14683:2014 Medical face masks - Requirements and test methods
    I.S. EN 14683:2014 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
    UNE-EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
    I.S. EN 455-3:2015 MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
    EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
    EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
    EN ISO 4074:2015 Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
    BS EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches
    12/30260949 DC : 0 BS EN 14683 - MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHOD
    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)
    PREN 13795-2 : DRAFT 2017 SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS
    I.S. 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
    BS EN ISO 4074:2015 Natural rubber latex male condoms. Requirements and test methods
    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 9394:2012 Ophthalmic optics — Contact lenses and contact lens care products — Determination of biocompatibility by ocular study with rabbit eyes
    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    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 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    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
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