Current AAMI Standards

  • 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

    from 311.96 EUR VAT excluded

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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

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

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  • Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers

    Standard [CURRENT] 2012

    AAMI ST 15883-3:2012

    Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

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  • Washer-disinfectors - Part 1: General requirements, terms and definitions and tests

    Standard [CURRENT] 2012

    AAMI ST 15883-1+A1+A2:2012

    Washer-disinfectors - Part 1: General requirements, terms and definitions and tests

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

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  • Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products

    Standard [CURRENT] 2012

    AAMI/ISO 13408-7:2012

    Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products

    from 221.80 EUR VAT included

    from 207.29 EUR VAT excluded

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  • Medical products containing viable human cells - Application of risk management and requirements for processing practices

    Standard [CURRENT] 2012

    AAMI/ISO 13022:2012

    Medical products containing viable human cells - Application of risk management and requirements for processing practices

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems

    Standard [CURRENT] 2012

    AAMI/ISO 11658:2012

    Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems

    from 156.80 EUR VAT included

    from 146.54 EUR VAT excluded

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  • Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

    Standard [CURRENT] 2012

    AAMI/ISO 10993-12:2012

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

    from 221.80 EUR VAT included

    from 207.29 EUR VAT excluded

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  • Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations.

    Technical rule [CURRENT] 2012

    AAMI/IEC TIR 80001-2-4:2012

    Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations.

    from 221.80 EUR VAT included

    from 207.29 EUR VAT excluded

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  • Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

    Technical rule [CURRENT] 2012

    AAMI/IEC TIR 80001-2-2:2012

    Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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