Current AAMI Standards

  • Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples.

    Technical rule [CURRENT] 2012

    AAMI/IEC TIR 80001-2-1:2012

    Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples.

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition

    Technical rule [CURRENT] 2012

    AAMI/IEC TIR 62348:2012

    Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition

    from 647.40 EUR VAT included

    from 605.05 EUR VAT excluded

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  • Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

    Standard [CURRENT] 2012

    AAMI/IEC 60601-2-47:2012

    Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

    from 607.00 EUR VAT included

    from 567.29 EUR VAT excluded

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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

    from 221.80 EUR VAT included

    from 207.29 EUR VAT excluded

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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

    from 256.45 EUR VAT excluded

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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

    from 274.40 EUR VAT included

    from 256.45 EUR VAT excluded

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  • Medical devices utilizing animal tissues and their derivatives - Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes

    Technical rule [CURRENT] 2011

    AAMI/ISO TIR 22442-4:2011

    Medical devices utilizing animal tissues and their derivatives - Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes

    from 221.80 EUR VAT included

    from 207.29 EUR VAT excluded

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  • Cardiovascular implants - Endovascular devices - Part 3: Vena Cava Filters

    Standard [CURRENT] 2011

    AAMI/ISO 25539-3:2011

    Cardiovascular implants - Endovascular devices - Part 3: Vena Cava Filters

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

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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

    from 333.80 EUR VAT included

    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

    from 255.40 EUR VAT included

    from 238.69 EUR VAT excluded

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