Current AAMI Standards

274 search results

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

    Standard [CURRENT] 2024

    AAMI/ISO 23500-1:2024

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

    Standard [CURRENT] 2024

    AAMI/ISO 23500-2:2024

    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 3: Water for haemodialysis and related therapies

    Standard [CURRENT] 2024

    AAMI/ISO 23500-3:2024

    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 4: Concentrates for haemodialysis and related therapies

    Standard [CURRENT] 2024

    AAMI/ISO 23500-4:2024

    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 5: Quality of dialysis fluid for haemodialysis and related therapies

    Standard [CURRENT] 2024

    AAMI/ISO 23500-5:2024

    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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  • Microbiological aspects of ethylene oxide sterilization

    Technical rule [CURRENT] 2023

    AAMI TIR 16:2023

    Microbiological aspects of ethylene oxide sterilization

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Standard for medical device security - Security risk management for device manufacturers

    Standard [CURRENT] 2023

    AAMI SW 96:2023

    Standard for medical device security - Security risk management for device manufacturers

    from 333.80 EUR VAT included

    from 311.96 EUR VAT excluded

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  • Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2

    Technical rule [CURRENT] 2023

    AAMI/ISO TIR 16775:2023

    Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2

    from 463.70 EUR VAT included

    from 433.36 EUR VAT excluded

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  • Aseptic processing of health care products - Part 1: General requirements

    Standard [CURRENT] 2023

    AAMI/ISO 13408-1:2023

    Aseptic processing of health care products - Part 1: General requirements

    from 386.40 EUR VAT included

    from 361.12 EUR VAT excluded

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  • Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems Amendment 1: Application of risk management

    Standard [CURRENT] 2023

    AAMI/ISO 11607-1/A1:2023

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems Amendment 1: Application of risk management

    from 221.80 EUR VAT included

    from 207.29 EUR VAT excluded

    To selection
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