Current AAMI Standards

  • Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

    Standard [CURRENT] 2016

    AAMI/ISO 80369-5:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

    from 471.50 EUR VAT included

    from 440.65 EUR VAT excluded

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  • Small-bore connectors for liquids and gases in healthcare applications - Part 3: connectors for enteral applications

    Standard [CURRENT] 2016

    AAMI/ISO 80369-3:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 3: connectors for enteral applications

    This document has been modified by: AAMI/ISO 80369-3/A1:2019

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)

    Standard [CURRENT] 2016

    AAMI/ISO 7199:2016

    Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

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  • Cardiovascular implants - Tubular vascular prostheses

    Standard [CURRENT] 2016

    AAMI/ISO 7198:2016

    Cardiovascular implants - Tubular vascular prostheses

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling

    Standard [CURRENT] 2016

    AAMI/ISO 22442-2:2016

    Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

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  • Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management

    Standard [CURRENT] 2016

    AAMI/ISO 22442-1:2016

    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management

    from 274.40 EUR VAT included

    from 256.45 EUR VAT excluded

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  • Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps

    Standard [CURRENT] 2016

    AAMI/ISO 18242:2016

    Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps

    from 179.20 EUR VAT included

    from 167.48 EUR VAT excluded

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  • Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps

    Standard [CURRENT] 2016

    AAMI/ISO 18241:2016

    Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps

    from 221.80 EUR VAT included

    from 207.29 EUR VAT excluded

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  • Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

    Standard [CURRENT] 2016

    AAMI/ISO 15674:2016

    Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

    from 156.80 EUR VAT included

    from 146.54 EUR VAT excluded

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  • Medical devices - Quality management systems - Requirements for regulatory purposes

    Standard [CURRENT] 2016

    AAMI/ISO 13485:2016

    Medical devices - Quality management systems - Requirements for regulatory purposes

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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