Current AAMI Standards

  • Risk management of radio-frequency wireless coexistence for medical devices and systems

    Technical rule [CURRENT] 2017

    AAMI TIR 69:2017

    Risk management of radio-frequency wireless coexistence for medical devices and systems

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Guidance for logging of alarm system data

    Technical rule [CURRENT] 2017

    AAMI TIR 71:2017

    Guidance for logging of alarm system data

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

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  • Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting

    Standard [CURRENT] 2017

    AAMI CI 86:2017

    Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

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  • Processing of health care products - Quality management systems for processing in health care facilities

    Standard [CURRENT] 2017

    AAMI ST 90:2017

    Processing of health care products - Quality management systems for processing in health care facilities

    from 312.50 EUR VAT included

    from 292.06 EUR VAT excluded

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  • Dialysis fluid chemical composition

    Technical rule [CURRENT] 2017

    AAMI TIR 72:2017

    Dialysis fluid chemical composition

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

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  • Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

    Standard [CURRENT] 2016

    AAMI/ISO 15676:2016

    Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

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  • Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters

    Standard [CURRENT] 2016

    AAMI/ISO 15675:2016

    Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters

    from 156.80 EUR VAT included

    from 146.54 EUR VAT excluded

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  • Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass

    Technical rule [CURRENT] 2016

    AAMI/ISO TIR 19024:2016

    Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass

    from 221.80 EUR VAT included

    from 207.29 EUR VAT excluded

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  • Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

    Standard [CURRENT] 2016

    AAMI/ISO 80369-7:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications

    Standard [CURRENT] 2016

    AAMI/ISO 80369-6:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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