Current AAMI Standards

273 search results

  • Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies

    Standard [CURRENT] 2019

    AAMI/ISO 23500-5:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies

    from 221.80 EUR VAT included

    from 207.29 EUR VAT excluded

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  • Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies

    Standard [CURRENT] 2019

    AAMI/ISO 23500-4:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies

    from 274.40 EUR VAT included

    from 256.45 EUR VAT excluded

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  • Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies

    Standard [CURRENT] 2019

    AAMI/ISO 23500-3:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies

    from 221.80 EUR VAT included

    from 207.29 EUR VAT excluded

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  • Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies

    Standard [CURRENT] 2019

    AAMI/ISO 23500-2:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies

    from 312.50 EUR VAT included

    from 292.06 EUR VAT excluded

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  • Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements

    Standard [CURRENT] 2019

    AAMI/ISO 23500-1:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

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  • Aseptic processing of health care products - Part 2: Sterilizing filtration

    Standard [CURRENT] 2018

    AAMI/ISO 13408-2:2018

    Aseptic processing of health care products - Part 2: Sterilizing filtration

    from 254.20 EUR VAT included

    from 237.57 EUR VAT excluded

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  • Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products

    Standard [CURRENT] 2018

    AAMI/ISO 11737-1:2018

    Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products

    This document has been modified by: AAMI/ISO 11737-1/A1:2021

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Sterilization of health-care products- Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release

    Standard [CURRENT] 2018

    AAMI/ISO 11135/A1:2018

    Sterilization of health-care products- Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release

    from 359.50 EUR VAT included

    from 335.98 EUR VAT excluded

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  • Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

    Standard [CURRENT] 2018

    AAMI/ISO 10993-1:2018

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers

    Standard [CURRENT] 2018

    AAMI/IEC 80601-2-30:2018

    Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers

    from 524.20 EUR VAT included

    from 489.91 EUR VAT excluded

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