Current AAMI Standards

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  • Sustainability of medical devices - Elements of a responsible product life cycle

    Technical rule [CURRENT] 2015

    AAMI TIR 65:2015

    Sustainability of medical devices - Elements of a responsible product life cycle

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  • Guidance for the use of medical equipment maintenance strategies and procedures

    Standard [CURRENT] 2015

    AAMI EQ 89:2015

    Guidance for the use of medical equipment maintenance strategies and procedures

    from 179.20 EUR VAT included

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  • Sterilization of health care products - Moist Heat - Guidance on the designation of a medical product to a product family and processing category for steam sterilization

    Technical rule [CURRENT] 2014

    AAMI/ISO TIR 17665-3:2014

    Sterilization of health care products - Moist Heat - Guidance on the designation of a medical product to a product family and processing category for steam sterilization

    from 333.80 EUR VAT included

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  • Application of risk management for IT-networks incorporating medical - Application guidance - Part 2-6: Guidance for responsibility agreements

    Technical rule [CURRENT] 2014

    AAMI/ISO TIR 80001-2-6:2014

    Application of risk management for IT-networks incorporating medical - Application guidance - Part 2-6: Guidance for responsibility agreements

    from 179.20 EUR VAT included

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  • Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants

    Technical rule [CURRENT] 2014

    AAMI/ISO TIR 37137:2014

    Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants

    from 179.20 EUR VAT included

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  • Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

    Standard [CURRENT] 2014

    AAMI/ISO 14708-1:2014

    Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

    from 333.80 EUR VAT included

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  • Sterilization of health care products - Chemical indicators - Part 1: General requirements

    Standard [CURRENT] 2014

    AAMI/ISO 11140-1:2014

    Sterilization of health care products - Chemical indicators - Part 1: General requirements

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  • Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices

    Standard [CURRENT] 2014

    AAMI/ISO 11135:2014

    Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices

    This document has been modified by: AAMI/ISO 11135/A1:2018

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  • Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity

    Standard [CURRENT] 2014

    AAMI/ISO 10993-3:2014

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity

    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 2-7: Application guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

    Technical rule [CURRENT] 2014

    AAMI/IEC TIR 80001-2-7:2014

    Application of risk management for IT-networks incorporating medical devices - Part 2-7: Application guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

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