Current AAMI Standards

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  • Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes

    Standard [CURRENT] 2022

    AAMI/ISO 5840-2:2022

    Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements

    Standard [CURRENT] 2022

    AAMI/ISO 5840-1:2022

    Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

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  • Sterilization of health care products - Biological and chemical indicators - Test equipment

    Standard [CURRENT] 2022

    AAMI/ISO 18472:2022

    Sterilization of health care products - Biological and chemical indicators - Test equipment

    from 312.50 EUR VAT included

    from 292.06 EUR VAT excluded

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  • Medical devices - Symbols to be used with information to be supplied by the manufacturer- Part 1: General requirements

    Standard [CURRENT] 2022

    AAMI/ISO 15223-1:2022

    Medical devices - Symbols to be used with information to be supplied by the manufacturer- Part 1: General requirements

    from 312.50 EUR VAT included

    from 292.06 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 1: Critical and semi-critical medical devices

    Standard [CURRENT] 2022

    AAMI/ISO 17664-1:2022

    Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices

    from 274.40 EUR VAT included

    from 256.45 EUR VAT excluded

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  • Guidance on transferring health care products between radiation sterilization sources

    Technical rule [CURRENT] 2022

    AAMI TIR 104:2022

    Guidance on transferring health care products between radiation sterilization sources

    from 274.40 EUR VAT included

    from 256.45 EUR VAT excluded

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  • 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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