Current AAMI Standards

273 search results

  • Active implantable medical devices- Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging

    Standard [CURRENT] 2021

    AAMI PC 76:2021

    Active implantable medical devices- Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

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  • Flexible and semi-rigid endoscope processing in health care facilities

    Standard [CURRENT] 2021

    AAMI ST 91:2021

    Flexible and semi-rigid endoscope processing in health care facilities

    from 450.20 EUR VAT included

    from 420.75 EUR VAT excluded

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  • Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1

    Standard [CURRENT] 2021

    AAMI/ISO 11737-1/A1:2021

    Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

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  • Medical devices - Information to be supplied by the manufacturer

    Standard [CURRENT] 2021

    AAMI/ISO 20417:2021

    Medical devices - Information to be supplied by the manufacturer

    from 386.40 EUR VAT included

    from 361.12 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

    from 24.11 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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  • Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials

    Technical rule [CURRENT] 2020

    AAMI/ISO TIR 10993-19:2020

    Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials

    from 221.80 EUR VAT included

    from 207.29 EUR VAT excluded

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  • Medical devices - Guidance on the application of ISO 14971

    Technical rule [CURRENT] 2020

    AAMI/ISO TIR 24971:2020

    Medical devices - Guidance on the application of ISO 14971

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

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  • Medical devices - Post-market surveillance for manufacturers

    Technical rule [CURRENT] 2020

    AAMI/ISO TIR 20416:2020

    Medical devices - Post-market surveillance for manufacturers

    from 312.50 EUR VAT included

    from 292.06 EUR VAT excluded

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  • Clinical investigation of medical devices for human subjects - Good clinical practice

    Standard [CURRENT] 2020

    AAMI/ISO 14155:2020

    Clinical investigation of medical devices for human subjects - Good clinical practice

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

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