Current AAMI Standards

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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

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  • Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods

    Standard [CURRENT] 2015

    AAMI/ISO 80369-20:2015

    Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods

    from 312.50 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

    from 254.20 EUR VAT included

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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

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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

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  • Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance for distributed alarm systems

    Technical rule [CURRENT] 2014

    AAMI/IEC TIR 80001-2-5:2014

    Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance for distributed alarm systems

    from 415.50 EUR VAT included

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  • Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

    Standard [CURRENT] 2014

    AAMI/IEC 60601-1-2:2014

    Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

    This document has been modified by: AAMI/IEC 60601-1-2/A1:2021

    from 647.40 EUR VAT included

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  • Environmental monitoring for terminally sterilized healthcare products

    Technical rule [CURRENT] 2014

    AAMI TIR 52:2014

    Environmental monitoring for terminally sterilized healthcare products

    from 156.80 EUR VAT included

    from 146.54 EUR VAT excluded

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