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    I.S. EN 60601-1-8:2007&A1:2013/ac&A11:2017

    Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

    National Standards Authority of Ireland

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    I.S. EN ISO 15223-1:2016&LC:2016

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

    National Standards Authority of Ireland

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    I.S. EN ISO 15378:2017

    PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017)

    National Standards Authority of Ireland

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    I.S. EN ISO 9626:2016

    STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS

    National Standards Authority of Ireland

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    ISO 10993-17 : 2002(R2016)

    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES

    International Organization for Standardization

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    I.S. EN 60601-2-62:2015

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-62: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) EQUIPMENT

    National Standards Authority of Ireland

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    I.S. EN 60601-2-36:2015

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY

    National Standards Authority of Ireland

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    I.S. EN 45502-1:2015

    IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER

    National Standards Authority of Ireland

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    S.R. 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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