Current AAMI Standards

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  • Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

    Standard [CURRENT] 2011

    AAMI/IEC 60601-2-25:2011

    Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

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  • Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators

    Technical rule [CURRENT] 2011

    AAMI TIR 41:2011

    Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

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  • Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

    Standard [CURRENT] 2011

    AAMI/IEC 60601-2-27:2011

    Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

    from 607.00 EUR VAT included

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  • Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation

    Standard [CURRENT] 2010

    AAMI/ISO 15223-2:2010

    Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

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  • Sterilization of health care products - Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices

    Standard [CURRENT] 2010

    AAMI/ISO 20857:2010

    Sterilization of health care products - Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric devices

    Standard [CURRENT] 2010

    AAMI/ISO 10993-13:2010

    Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric devices

    from 160.20 EUR VAT included

    from 149.72 EUR VAT excluded

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  • Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

    Standard [CURRENT] 2010

    AAMI/ISO 10993-10:2010

    Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities.

    Standard [CURRENT] 2010

    AAMI/IEC 80001-1:2010

    Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities.

    from 471.50 EUR VAT included

    from 440.65 EUR VAT excluded

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  • Guidance on electromagnetic compatibility of medical devices in healthcare facilities

    Technical rule [CURRENT] 2010

    AAMI TIR 18:2010

    Guidance on electromagnetic compatibility of medical devices in healthcare facilities

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Sterilization of health care products - Moist Heat - Part 2: Guidance on the application of AAMI/ISO 17665-1

    Technical rule [CURRENT] 2009

    AAMI/ISO TIR 17665-2:2009

    Sterilization of health care products - Moist Heat - Part 2: Guidance on the application of AAMI/ISO 17665-1

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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