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    SR CEN/CLC TR 14060:2014

    MEDICAL DEVICE TRACEABILITY ENABLED BY UNIQUE DEVICE IDENTIFICATION (UDI)

    National Standards Authority of Ireland

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    I.S. EN 15986:2011

    SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES

    National Standards Authority of Ireland

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    I.S. EN 80001-1:2011

    APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES

    National Standards Authority of Ireland

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    I.S. EN ISO 10993-15:2009

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS (ISO 10993-15:2000)

    National Standards Authority of Ireland

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    I.S. EN ISO 10993-5:2009

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY (ISO 10993-5:2009)

    National Standards Authority of Ireland

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    I.S. EN ISO 10993-17:2009

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES (ISO 10993-17:2002)

    National Standards Authority of Ireland

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    I.S. EN 80601-2-35:2009

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE

    National Standards Authority of Ireland

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    I.S. EN ISO 10993-1:2009+AC:2010

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009)

    National Standards Authority of Ireland

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    I.S. EN 1041:2008:INC:AMD 1:2013

    INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES

    National Standards Authority of Ireland

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    I.S. EN ISO 10993-2:2006

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS (ISO 10993-2:2006)

    National Standards Authority of Ireland