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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 10993-17:2009

    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 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 1041:2008+A1:2013

    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

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    I.S. CEN/TR 15133:2005

    NOMENCLATURE - COLLECTIVE TERMS AND CODES FOR GROUPS OF MEDICAL DEVICES

    National Standards Authority of Ireland

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    I.S. ENV 13004:1999

    NOMENCLATURE SYSTEM FOR MEDICAL DEVICES FOR THE PURPOSES OF REGULATORY DATA EXCHANGE - RECOMMENDATIONS FOR AN INTERIM SYSTEM AND RULES FOR A FUTURE

    National Standards Authority of Ireland

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    S.R. CEN ISO/TR 20416:2020

    Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)

    National Standards Authority of Ireland

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    S.R. CEN ISO/TR 24971:2020

    Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

    National Standards Authority of Ireland

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