Current AAMI Standards

273 search results

  • Standard for Medical Device Interoperability

    Standard [CURRENT] 2022

    AAMI/UL 2800-1:2022

    Standard for Medical Device Interoperability

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    from 361.12 EUR VAT excluded

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  • Standard for Risk Concerns for Interoperable Medical Products

    Standard [CURRENT] 2022

    AAMI/UL 2800-1-1:2022

    Standard for Risk Concerns for Interoperable Medical Products

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Standard for Interoperable Item Development Life Cycle

    Standard [CURRENT] 2022

    AAMI/UL 2800-1-2:2022

    Standard for Interoperable Item Development Life Cycle

    from 312.50 EUR VAT included

    from 292.06 EUR VAT excluded

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  • Standard for Interoperable Item Integration Life Cycle

    Standard [CURRENT] 2022

    AAMI/UL 2800-1-3:2022

    Standard for Interoperable Item Integration Life Cycle

    from 274.40 EUR VAT included

    from 256.45 EUR VAT excluded

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  • Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD

    Standard [CURRENT] 2022

    AAMI/ISO 13004:2022

    Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Sterilization of health care products - Microbiological methods - Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products

    Technical rule [CURRENT] 2022

    AAMI/ISO TIR 22456:2022

    Sterilization of health care products - Microbiological methods - Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products

    from 221.80 EUR VAT included

    from 207.29 EUR VAT excluded

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  • Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices

    Standard [CURRENT] 2022

    AAMI/ISO 17664-2:2022

    Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices

    from 274.40 EUR VAT included

    from 256.45 EUR VAT excluded

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  • Fluid delivery performance testing for infusion pumps

    Technical rule [CURRENT] 2021

    AAMI TIR 101:2021

    Fluid delivery performance testing for infusion pumps

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • 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, Amendment 2

    Standard [CURRENT] 2021

    AAMI/IEC 60601-1-8/A2:2021

    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, Amendment 2

    from 535.40 EUR VAT included

    from 500.37 EUR VAT excluded

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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, Amendment 1

    Standard [CURRENT] 2021

    AAMI/IEC 60601-1-2/A1:2021

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

    from 415.50 EUR VAT included

    from 388.32 EUR VAT excluded

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