Current AAMI Standards

  • Human factors engineering-Design of medical devices

    Standard [CURRENT] 2025

    AAMI HE 75:2025

    Human factors engineering-Design of medical devices

    from 878.10 EUR VAT included

    from 820.65 EUR VAT excluded

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  • Best practices for designing accessible at-home diagnostic test kits

    Technical rule [CURRENT] 2025

    AAMI TIR 130:2025

    Best practices for designing accessible at-home diagnostic test kits

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

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  • External transport of reusable medical devices for processing

    Technical rule [CURRENT] 2025

    AAMI TIR 109:2025

    External transport of reusable medical devices for processing

    from 274.40 EUR VAT included

    from 256.45 EUR VAT excluded

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  • Cybersecurity considerations unique to machine learning–enabled medical devices

    Technical rule [CURRENT] 2025

    AAMI CR 515:2025

    Cybersecurity considerations unique to machine learning–enabled medical devices

    from 221.80 EUR VAT included

    from 207.29 EUR VAT excluded

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  • Healthcare technology management (HTM) educational programs Corrigendum 1

    Standard [CURRENT] 2024

    AAMI EQ110 Corrigendum 1:2024

    Healthcare technology management (HTM) educational programs Corrigendum 1

    Free of charge

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  • Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

    Standard [CURRENT] 2024

    AAMI/IEC 80601-2-58:2024

    Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

    from 415.50 EUR VAT included

    from 388.32 EUR VAT excluded

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  • Healthcare technology management (HTM) educational programs

    Standard [CURRENT] 2024

    AAMI EQ 110:2024

    Healthcare technology management (HTM) educational programs

    This document has been modified by: AAMI EQ110 Corrigendum 1:2024

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

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  • Chemical sterilization and high-level disinfection in health care facilities

    Standard [CURRENT] 2024

    AAMI ST 58:2024

    Chemical sterilization and high-level disinfection in health care facilities

    from 463.70 EUR VAT included

    from 433.36 EUR VAT excluded

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  • Microbiological methods - Understanding and use of product bioburden data

    Technical rule [CURRENT] 2024

    AAMI TIR 106:2024

    Microbiological methods - Understanding and use of product bioburden data

    from 274.40 EUR VAT included

    from 256.45 EUR VAT excluded

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  • Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers

    Standard [CURRENT] 2024

    AAMI/ISO 11140-6:2024

    Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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