Current AAMI Standards

273 search results

  • Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

    Standard [CURRENT] 2011

    AAMI/IEC 60601-2-27:2011

    Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

    from 607.00 EUR VAT included

    from 567.29 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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  • Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric devices

    Standard [CURRENT] 2010

    AAMI/ISO 10993-13:2010

    Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric devices

    from 160.20 EUR VAT included

    from 149.72 EUR VAT excluded

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  • Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

    Standard [CURRENT] 2010

    AAMI/ISO 10993-10:2010

    Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities.

    Standard [CURRENT] 2010

    AAMI/IEC 80001-1:2010

    Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities.

    from 471.50 EUR VAT included

    from 440.65 EUR VAT excluded

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  • Guidance on electromagnetic compatibility of medical devices in healthcare facilities

    Technical rule [CURRENT] 2010

    AAMI TIR 18:2010

    Guidance on electromagnetic compatibility of medical devices in healthcare facilities

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation

    Standard [CURRENT] 2010

    AAMI/ISO 15223-2:2010

    Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

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  • Sterilization of health care products - Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices

    Standard [CURRENT] 2010

    AAMI/ISO 20857:2010

    Sterilization of health care products - Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

    Standard [CURRENT] 2009

    AAMI/ISO 14937:2009

    Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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