Current AAMI Standards

274 search results

  • Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors

    Standard [CURRENT] 2020

    AAMI MP 80601-2-49:2020

    Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors

    from 471.50 EUR VAT included

    from 440.65 EUR VAT excluded

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  • Medical devices - Part 1: Application of usability engineering to medical devices + Amendment 1

    Standard [CURRENT] 2020

    AAMI/IEC 62366-1+A1:2020

    Medical devices - Part 1: Application of usability engineering to medical devices + Amendment 1

    from 1262.20 EUR VAT included

    from 1179.63 EUR VAT excluded

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  • Safety and effectiveness of health IT software and systems - Part 4: Application of human factors engineering

    Pre-standard 2020

    AAMI HIT 1000-4 (PS):2020

    Safety and effectiveness of health IT software and systems - Part 4: Application of human factors engineering

    from 25.80 EUR VAT included

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  • Reprocessing of hemodialyzers

    Standard [CURRENT] 2020

    AAMI RD 47:2020

    Reprocessing of hemodialyzers

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Comprehensive guide to steam sterilization and sterility assurance in health care facilities

    Standard [CURRENT] 2020

    AAMI ST 79+A1+A2+A3+A4:2020

    Comprehensive guide to steam sterilization and sterility assurance in health care facilities

    from 560.00 EUR VAT included

    from 523.36 EUR VAT excluded

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  • Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

    Standard [CURRENT] 2020

    AAMI/ISO 10993-16:2020

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

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  • Radiation therapy machine characterization

    Standard [CURRENT] 2020

    AAMI RT 3:2020

    Radiation therapy machine characterization

    Free of charge

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  • Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1

    Standard [CURRENT] 2019

    AAMI/ISO 80369-3/A1:2019

    Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1

    from 179.20 EUR VAT included

    from 167.48 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 1: General requirements and conceptual model

    Standard [CURRENT] 2019

    AAMI 2700-1:2019

    Medical Devices and Medical Systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model

    from 274.40 EUR VAT included

    from 256.45 EUR VAT excluded

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  • U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems

    Technical rule [CURRENT] 2019

    AAMI TIR 102:2019

    U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

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