Current AAMI Standards

273 search results

  • Medical devices and medical systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging

    Standard [CURRENT] 2022

    AAMI 2700-2-1:2022

    Medical devices and medical systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging

    from 312.50 EUR VAT included

    from 292.06 EUR VAT excluded

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  • Safety and effectiveness of health IT software and systems - Part 1: Fundamental concepts, principles, and requirements

    Standard [CURRENT] 2022

    AAMI HIT 1000-1:2022

    Safety and effectiveness of health IT software and systems - Part 1: Fundamental concepts, principles, and requirements

    from 312.50 EUR VAT included

    from 292.06 EUR VAT excluded

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  • Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

    Standard [CURRENT] 2022

    AAMI PB 70:2022

    Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices

    Standard [CURRENT] 2022

    AAMI ST 98:2022

    Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices

    from 312.50 EUR VAT included

    from 292.06 EUR VAT excluded

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  • Standard for Medical Device Interoperability

    Standard [CURRENT] 2022

    AAMI/UL 2800-1:2022

    Standard for Medical Device Interoperability

    from 386.40 EUR VAT included

    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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