Current AAMI Standards

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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

    To selection
  • 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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  • 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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  • 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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  • 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

    To selection
  • Quality Management System (QMS) guidance on compliance with FDA's Final Rule on combination products

    Technical rule [CURRENT] 2024

    AAMI TIR 48:2024

    Quality Management System (QMS) guidance on compliance with FDA's Final Rule on combination products

    from 312.50 EUR VAT included

    from 292.06 EUR VAT excluded

    To selection
  • General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities

    Standard [CURRENT] 2024

    AAMI ST 24:2024

    General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities

    from 274.40 EUR VAT included

    from 256.45 EUR VAT excluded

    To selection
  • Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing

    Technical rule [CURRENT] 2024

    AAMI CR 513:2024

    Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

    To selection
  • Processing of dilators, transesophageal and ultrasound probes in health care facilities

    Technical rule [CURRENT] 2024

    AAMI TIR 99:2024

    Processing of dilators, transesophageal and ultrasound probes in health care facilities

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

    To selection
  • Compatibility of materials subject to sterilization

    Technical rule [CURRENT] 2024

    AAMI TIR 17:2024

    Compatibility of materials subject to sterilization

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

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  • Standard for a medical equipment management program

    Standard [CURRENT] 2024

    AAMI EQ 56:2024

    Standard for a medical equipment management program

    from 312.50 EUR VAT included

    from 292.06 EUR VAT excluded

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  • Alternate equipment management (AEM) program in healthcare delivery organizations (HDOs)

    Standard [CURRENT] 2024

    AAMI EQ 103:2024

    Alternate equipment management (AEM) program in healthcare delivery organizations (HDOs)

    from 274.40 EUR VAT included

    from 256.45 EUR VAT excluded

    To selection
  • 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

    To selection
  • Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2

    Technical rule [CURRENT] 2023

    AAMI/ISO TIR 16775:2023

    Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2

    from 463.70 EUR VAT included

    from 433.36 EUR VAT excluded

    To selection
  • Aseptic processing of health care products - Part 1: General requirements

    Standard [CURRENT] 2023

    AAMI/ISO 13408-1:2023

    Aseptic processing of health care products - Part 1: General requirements

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

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  • Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems Amendment 1: Application of risk management

    Standard [CURRENT] 2023

    AAMI/ISO 11607-1/A1:2023

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems Amendment 1: Application of risk management

    from 221.80 EUR VAT included

    from 207.29 EUR VAT excluded

    To selection
  • Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management

    Standard [CURRENT] 2023

    AAMI/ISO 11607-2/A1:2023

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

    To selection
  • Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation item for a biological indicator

    Standard [CURRENT] 2023

    AAMI/ISO 11138-8:2023

    Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation item for a biological indicator

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

    To selection
  • Water for the processing of medical devices

    Standard [CURRENT] 2023

    AAMI ST 108:2023

    Water for the processing of medical devices

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

    To selection
  • Microbiological aspects of ethylene oxide sterilization

    Technical rule [CURRENT] 2023

    AAMI TIR 16:2023

    Microbiological aspects of ethylene oxide sterilization

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

    To selection
  • Application of ISO 14971 to machine learning in artificial intelligence - Guide

    Technical rule [CURRENT] 2023

    AAMI TIR 34971:2023

    Application of ISO 14971 to machine learning in artificial intelligence - Guide

    from 274.40 EUR VAT included

    from 256.45 EUR VAT excluded

    To selection
  • Guidance on the use of AGILE practices in the development of medical device software

    Technical rule [CURRENT] 2023

    AAMI TIR 45:2023

    Guidance on the use of AGILE practices in the development of medical device software

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

    To selection
  • Standard for medical device security - Security risk management for device manufacturers

    Standard [CURRENT] 2023

    AAMI SW 96:2023

    Standard for medical device security - Security risk management for device manufacturers

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

    To selection
  • Sterilization of health care products - Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release

    Technical rule [CURRENT] 2023

    AAMI/ISO TIR 21387:2023

    Sterilization of health care products - Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release

    from 221.80 EUR VAT included

    from 207.29 EUR VAT excluded

    To selection
  • Sterilization of health care products - Radiation - Part 4: Guidance on process control

    Technical rule [CURRENT] 2022

    AAMI/ISO TIR 11137-4:2022

    Sterilization of health care products - Radiation - Part 4: Guidance on process control

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

    To selection
  • Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques

    Standard [CURRENT] 2022

    AAMI/ISO 5840-3:2022

    Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

    To selection
  • 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

    To selection
  • 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

    To selection
  • 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

    To selection
  • 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

    To selection
  • 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

    To selection
  • 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

    To selection
  • 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

    To selection
  • 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

    To selection
  • 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

    To selection
  • 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

    To selection
  • 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

    To selection
  • 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

    To selection
  • 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

    To selection
  • 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

    To selection
  • 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

    To selection
  • 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

    To selection
  • 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

    To selection
  • 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

    To selection
  • 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

    To selection
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