Current AAMI Standards

273 search results

  • Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, Amendment 1

    Standard [CURRENT] 2021

    AAMI HA 60601-1-11/A1:2021

    Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, Amendment 1

    from 156.80 EUR VAT included

    from 146.54 EUR VAT excluded

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  • Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, Amendment 2

    Standard [CURRENT] 2021

    AAMI ES 60601-1/A2:2021

    Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, Amendment 2

    from 535.40 EUR VAT included

    from 500.37 EUR VAT excluded

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  • Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices

    Technical rule [CURRENT] 2021

    AAMI CR 510:2021

    Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices

    from 156.80 EUR VAT included

    from 146.54 EUR VAT excluded

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  • Evaluation of particulate associated with vascular medical devices

    Technical rule [CURRENT] 2021

    AAMI TIR 42:2021

    Evaluation of particulate associated with vascular medical devices

    from 312.50 EUR VAT included

    from 292.06 EUR VAT excluded

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  • Ultrapure dialysis fluid for hemodialysis and related therapies

    Technical rule [CURRENT] 2021

    AAMI TIR 43:2021

    Ultrapure dialysis fluid for hemodialysis and related therapies

    from 312.50 EUR VAT included

    from 292.06 EUR VAT excluded

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  • Water testing methodologies

    Technical rule [CURRENT] 2021

    AAMI TIR 58:2021

    Water testing methodologies

    from 312.50 EUR VAT included

    from 292.06 EUR VAT excluded

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  • Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmax SD-S

    Technical rule [CURRENT] 2021

    AAMI TIR 76:2021

    Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmax SD-S

    from 312.50 EUR VAT included

    from 292.06 EUR VAT excluded

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  • General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications

    Standard [CURRENT] 2021

    AAMI CN 27:2021

    General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications

    from 274.40 EUR VAT included

    from 256.45 EUR VAT excluded

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  • Active implantable medical devices- Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging

    Standard [CURRENT] 2021

    AAMI PC 76:2021

    Active implantable medical devices- Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

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  • Flexible and semi-rigid endoscope processing in health care facilities

    Standard [CURRENT] 2021

    AAMI ST 91:2021

    Flexible and semi-rigid endoscope processing in health care facilities

    from 450.20 EUR VAT included

    from 420.75 EUR VAT excluded

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