Current AAMI Standards

  • Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

    Standard [CURRENT] 2017

    AAMI/ISO 11138-2:2017

    Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

    from 156.80 EUR VAT included

    from 146.54 EUR VAT excluded

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  • Sterilization of health care products - Biological indicators - Part 1: General requirements

    Standard [CURRENT] 2017

    AAMI/ISO 11138-1:2017

    Sterilization of health care products - Biological indicators - Part 1: General requirements

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control

    Standard [CURRENT] 2017

    AAMI/ISO 11137-3:2017

    Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control

    from 312.50 EUR VAT included

    from 292.06 EUR VAT excluded

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  • Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

    Standard [CURRENT] 2017

    AAMI/ISO 10993-4:2017

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

    Standard [CURRENT] 2017

    AAMI/ISO 10993-11:2017

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

    from 285.60 EUR VAT included

    from 266.92 EUR VAT excluded

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  • Medical device software - Part 2: Validation of software for medical device quality systems

    Technical rule [CURRENT] 2017

    AAMI/ISO TIR 80002-2:2017

    Medical device software - Part 2: Validation of software for medical device quality systems

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

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  • Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

    Standard [CURRENT] 2017

    AAMI/IEC 60601-2-2:2017

    Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

    from 647.40 EUR VAT included

    from 605.05 EUR VAT excluded

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  • Systems used to forecast remaining pacemaker battery service life

    Technical rule [CURRENT] 2017

    AAMI TIR 21:2017

    Systems used to forecast remaining pacemaker battery service life

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Integrating human factors into design controls

    Technical rule [CURRENT] 2017

    AAMI TIR 59:2017

    Integrating human factors into design controls

    from 274.40 EUR VAT included

    from 256.45 EUR VAT excluded

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  • Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms

    Technical rule [CURRENT] 2017

    AAMI TIR 66:2017

    Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms

    from 274.40 EUR VAT included

    from 256.45 EUR VAT excluded

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