Current AAMI Standards

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  • Non-invasive blood pressure motion artifact - Testing and evaluation of NIBP device performance in the presence of motion artifact

    Technical rule [CURRENT] 2012

    AAMI TIR 44:2012

    Non-invasive blood pressure motion artifact - Testing and evaluation of NIBP device performance in the presence of motion artifact

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  • Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms

    Standard [CURRENT] 2012

    AAMI EC 57:2012

    Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms

    from 274.40 EUR VAT included

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  • Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup

    Technical rule [CURRENT] 2012

    AAMI/ISO TIR 23810:2012

    Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup

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  • Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks

    Technical rule [CURRENT] 2012

    AAMI/IEC TIR 80001-2-3:2012

    Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks

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  • Cardiac rhythm management devices - Symbols to be used with cardiac rhythm management device labels, and information to be supplied - General requirements

    Standard [CURRENT] 2012

    AAMI/ISO 27185:2012

    Cardiac rhythm management devices - Symbols to be used with cardiac rhythm management device labels, and information to be supplied - General requirements

    from 333.80 EUR VAT included

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  • Cardiovascular implants - Endovascular devices - Part 2: Vascular stents

    Standard [CURRENT] 2012

    AAMI/ISO 25539-2:2012

    Cardiovascular implants - Endovascular devices - Part 2: Vascular stents

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  • Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization proces

    Standard [CURRENT] 2011

    AAMI/ISO 14160:2011

    Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization proces

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    from 311.96 EUR VAT excluded

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  • High frequency surgical equipment - Operation and maintenance

    Technical rule [CURRENT] 2011

    AAMI/IEC TIR 61289:2011

    High frequency surgical equipment - Operation and maintenance

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    from 238.69 EUR VAT excluded

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  • Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators

    Technical rule [CURRENT] 2011

    AAMI TIR 41:2011

    Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators

    from 179.20 EUR VAT included

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  • Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

    Standard [CURRENT] 2011

    AAMI/IEC 60601-2-25:2011

    Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

    from 647.40 EUR VAT included

    from 605.05 EUR VAT excluded

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