Current AAMI Standards

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  • Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity

    Standard [CURRENT] 2014

    AAMI/ISO 10993-3:2014

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity

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  • Application of risk management for IT-networks incorporating medical devices - Part 2-7: Application guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

    Technical rule [CURRENT] 2014

    AAMI/IEC TIR 80001-2-7:2014

    Application of risk management for IT-networks incorporating medical devices - Part 2-7: Application guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

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  • Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance for distributed alarm systems

    Technical rule [CURRENT] 2014

    AAMI/IEC TIR 80001-2-5:2014

    Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance for distributed alarm systems

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  • Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

    Standard [CURRENT] 2014

    AAMI/IEC 60601-1-2:2014

    Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

    This document has been modified by: AAMI/IEC 60601-1-2/A1:2021

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  • Environmental monitoring for terminally sterilized healthcare products

    Technical rule [CURRENT] 2014

    AAMI TIR 52:2014

    Environmental monitoring for terminally sterilized healthcare products

    from 156.80 EUR VAT included

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  • Human factors engineering for processing medical devices

    Technical rule [CURRENT] 2014

    AAMI TIR 55:2014

    Human factors engineering for processing medical devices

    from 221.80 EUR VAT included

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  • Common mode rejection in ECG monitoring

    Technical rule [CURRENT] 2014

    AAMI TIR 60:2014

    Common mode rejection in ECG monitoring

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  • Generating reports for human factors design validation results for external cardiac defibrillator

    Technical rule [CURRENT] 2014

    AAMI TIR 61:2014

    Generating reports for human factors design validation results for external cardiac defibrillator

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

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  • Generating reports for the purpose of submitting defibrillation waveform data for evaluation

    Technical rule [CURRENT] 2014

    AAMI TIR 62:2014

    Generating reports for the purpose of submitting defibrillation waveform data for evaluation

    from 156.80 EUR VAT included

    from 146.54 EUR VAT excluded

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  • Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection

    Technical rule [CURRENT] 2014

    AAMI TIR 63:2014

    Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

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