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  • AAMI ST98:2022

    Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
    8/22/2022 - Paper - English - AAMI
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    €371.00

  • AAMI ST98:2022

    Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
    8/22/2022 - PDF - English - AAMI
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    €278.00

  • AAMI HA60601-1-11:2015 & A1:2021:2022

    Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015, MOD) CONSOLIDATED EDITION
    8/22/2022 - Paper - English - AAMI
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    €391.00

  • AAMI HA60601-1-11:2015 & A1:2021:2022

    Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015, MOD) CONSOLIDATED EDITION
    8/22/2022 - PDF - English - AAMI
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    €298.00

  • AAMI ES60601-1: 2005 & A1:2012 & A2:2021:2022

    Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) CONSOLIDATED EDITION
    8/22/2022 - Paper - English - AAMI
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    €1,349.00

  • AAMI ES60601-1: 2005 & A1:2012 & A2:2021:2022

    Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) CONSOLIDATED EDITION
    8/22/2022 - PDF - English - AAMI
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    €1,256.00

  • AAMI/IEC 60601-1-2:2014 & A1:2021:2022

    Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests CONSOLIDATED EDITION
    8/22/2022 - Paper - English - AAMI
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    €437.00

  • AAMI/IEC 60601-1-2:2014 & A1:2021:2022

    Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests CONSOLIDATED EDITION
    8/22/2022 - PDF - English - AAMI
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    €344.00

  • AAMI/IEC 60601-1-8:2006 & A1:2013 & A2:2021:2022

    MEDICAL ELECTRICAL EQUIPMENT - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems CONSOLIDATED EDITION
    8/22/2022 - Paper - English - AAMI
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    €1,117.00

  • AAMI/IEC 60601-1-8:2006 & A1:2013 & A2:2021:2022

    MEDICAL ELECTRICAL EQUIPMENT - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems CONSOLIDATED EDITION
    8/22/2022 - PDF - English - AAMI
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    €1,024.00

  • AAMI ST44 : 2002

    Resistometers used for characterizing the performance of biological and chemical indicators
    7/10/2022 - PDF - English - AAMI
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    €92.00

  • AAMI/ISO TIR 11137-4:2022

    Sterilization of health care products-Radiation-Part 4: Guidance on process control
    6/12/2022 - Paper - English - AAMI
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    €390.00

  • AAMI/ISO TIR 11137-4:2022

    Sterilization of health care products-Radiation-Part 4: Guidance on process control
    6/12/2022 - PDF - English - AAMI
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    €297.00

  • AAMI 2800-1-2:2022

    Standard for Interoperable Item Development Life Cycle (ANSI/AAMI/UL 2800-1-2:2022)
    6/10/2022 - Paper - English - AAMI
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    €371.00

  • AAMI 2800-1-2:2022

    Standard for Interoperable Item Development Life Cycle (ANSI/AAMI/UL 2800-1-2:2022)
    6/10/2022 - PDF - English - AAMI
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    €278.00

  • AAMI 2800-1:2022

    Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2022)
    6/10/2022 - Paper - English - AAMI
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    €437.00

  • AAMI 2800-1:2022

    Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2022)
    6/10/2022 - PDF - English - AAMI
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    €344.00

  • AAMI 2800-1-3:2022

    Standard for Interoperable Item Integration Life Cycle (ANSI/AAMI/UL 2800-1-3:2022)
    6/10/2022 - Paper - English - AAMI
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    €337.00

  • AAMI 2800-1-3:2022

    Standard for Interoperable Item Integration Life Cycle (ANSI/AAMI/UL 2800-1-3:2022)
    6/10/2022 - PDF - English - AAMI
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    €244.00

  • AAMI 2800-1-1:2022

    Standard for Risk Concerns for Interoperable Medical Products (ANSI/AAMI/UL 2800-1-1:2022)
    6/10/2022 - Paper - English - AAMI
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    €390.00

  • AAMI 2800-1-1:2022

    Standard for Risk Concerns for Interoperable Medical Products (ANSI/AAMI/UL 2800-1-1:2022)
    6/10/2022 - PDF - English - AAMI
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    €297.00

  • AAMI TIR100: 2021:2022

    End-to-end microbiological quality and sterility assurance
    5/10/2022 - Paper - English - AAMI
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    €262.00

  • AAMI TIR100: 2021:2022

    End-to-end microbiological quality and sterility assurance
    5/10/2022 - PDF - English - AAMI
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    €198.00

  • AAMI 2700-2-1: 2022:2022

    Medical devices and medical systems-Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging
    4/22/2022 - Paper - English - AAMI
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    €371.00

  • AAMI 2700-2-1: 2022:2022

    Medical devices and medical systems-Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging
    4/22/2022 - PDF - English - AAMI
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    €278.00

  • AAMI TIR104:2022

    Guidance on transferring health care products between radiation sterilization sources
    4/19/2022 - Paper - English - AAMI
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    €337.00

  • AAMI TIR104:2022

    Guidance on transferring health care products between radiation sterilization sources
    4/19/2022 - PDF - English - AAMI
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    €244.00

  • AAMI CR34971:2022

    Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
    4/1/2022 - Paper - English - AAMI
    Learn More
    €337.00

  • AAMI CR34971:2022

    Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
    4/1/2022 - PDF - English - AAMI
    Learn More
    €244.00

  • AAMI HA60601-1-11:2015/A1:2021:2022

    Amendment 1, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015, MOD)
    3/20/2022 - Paper - English - AAMI
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    €199.00

  • AAMI HA60601-1-11:2015/A1:2021:2022

    Amendment 1, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015, MOD)
    3/20/2022 - PDF - English - AAMI
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    €135.00

  • AAMI ES60601-1: 2005/A2:2021:2022

    Amendment 2, Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
    3/1/2022 - Paper - English - AAMI
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    €381.00

  • AAMI ES60601-1: 2005/A2:2021:2022

    Amendment 2, Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
    3/1/2022 - PDF - English - AAMI
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    €288.00

  • AAMI HIT1000-1: 2022:2022

    Safety and effectiveness of health IT software and systems-Part 1: Fundamental concepts, principles, and requirements
    3/1/2022 - Paper - English - AAMI
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    €371.00

  • AAMI HIT1000-1: 2022:2022

    Safety and effectiveness of health IT software and systems-Part 1: Fundamental concepts, principles, and requirements
    3/1/2022 - PDF - English - AAMI
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    €278.00

  • AAMI ST91:2021

    Flexible and semi-rigid endoscope processing in health care facilities
    12/21/2021 - Paper - English - AAMI
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    €495.00

  • AAMI ST91:2021

    Flexible and semi-rigid endoscope processing in health care facilities
    12/21/2021 - PDF - English - AAMI
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    €401.00

  • AAMI TIR 101:2021

    Fluid delivery performance testing for infusion pumps
    10/15/2021 - PDF - English - AAMI
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    €288.00

  • AAMI CR510:2021

    Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
    9/24/2021 - PDF - English - AAMI
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    €135.00

  • AAMI PC76:2021

    Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
    4/1/2021 - PDF - English - AAMI
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    €324.00

  • AAMI TIR42:2021

    Evaluation of particulate associated with vascular medical devices
    3/31/2021 - PDF - English - AAMI
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    €270.00

  • AAMI TIR76:2021

    Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method Vdmax SD-S
    3/31/2021 - PDF - English - AAMI
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    €270.00

  • AAMI TIR43:2021

    Ultrapure dialysis fluid for hemodialysis and related therapies
    2/26/2021 - PDF - English - AAMI
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    €270.00

  • AAMI/ISO 14155:2020

    Clinical investigation of medical devices for human subjects - Good clinical practice
    12/7/2020 - PDF - English - AAMI
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    €334.00

  • AAMI/ISO 10993-16:2017:2020

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
    11/6/2020 - PDF - English - AAMI
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    €155.00

  • AAMI/ISO 10993-15:2019:2020

    Biological evaluation of medical devices?Part 15: Identification and quantification of degradation products from metals and alloys
    10/5/2020 - PDF - English - AAMI
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    €155.00

  • AAMI TIR12:2020

    Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
    9/17/2020 - PDF - English - AAMI
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    €288.00

  • AAMI TIR105:2020

    Risk management guidance for combination products
    9/10/2020 - PDF - English - AAMI
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    €270.00

  • AAMI/IEC 60601-2-39:2018:2020

    Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
    8/26/2020 - PDF - English - AAMI
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    €237.00

  • AAMI/IEC 80601-2-77:2020

    Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
    8/3/2020 - PDF - English - AAMI
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    €279.00

  • AAMI/IEC 60601-2-16:2018:2020

    Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
    7/22/2020 - PDF - English - AAMI
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    €288.00

  • AAMI HIT1000-4 (PS):2020

    Safety and effectiveness of health IT software and systems - Part 4: Application of human factors engineering
    7/7/2020 - PDF - English - AAMI
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    €25.00

  • AAMI/IEC 62366-1: 2015+AMD1:2020 (Consolidated Text) (R2021)

    Medical devices - Part 1: Application of usability engineering to medical devices, including Amendment 1
    7/1/2020 - PDF - English - AAMI
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    €288.00

  • AAMI/ISO 8637-1:2017:2020

    Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
    7/1/2020 - PDF - English - AAMI
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    €237.00

  • AAMI/ISO 8637-3:2018:2020

    Extracorporeal systems for blood purification - Part 3: Plasmafilters
    7/1/2020 - PDF - English - AAMI
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    €192.00

  • AAMI/ISO 8637-2:2018:2020

    Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
    7/1/2020 - PDF - English - AAMI
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    €192.00

  • AAMI/ISO 10993-4:2017

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
    4/27/2020 - PDF - English - AAMI
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    €288.00

  • AAMI/ISO 10993-1:2018

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
    4/27/2020 - PDF - English - AAMI
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    €288.00

  • AAMI/ISO 10993-11:2017

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
    4/27/2020 - PDF - English - AAMI
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    €237.00

  • AAMI MP80601-2-49:2020

    Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
    3/24/2020 - PDF - English - AAMI
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    €270.00

  • AAMI RT3: 2020

    Radiation therapy machine characterization
    2/21/2020 - Paper - English - AAMI
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    €44.00

  • AAMI RT3: 2020

    Radiation therapy machine characterization
    2/21/2020 - PDF - English - AAMI
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    €0.00

  • AAMI/ISO TI (R2041)6:2020

    Medical devices - Post-market surveillance for manufacturers
    2/16/2020 - PDF - English - AAMI
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    €279.00

  • AAMI/ISO TI (R2497)1:2020

    Medical devices - Guidance on the application of ISO 14971
    2/2/2020 - PDF - English - AAMI
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    €334.00

  • AAMI RD47:2020

    Reprocessing of hemodialyzers
    1/23/2020 - Paper - English - AAMI
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    €381.00

  • AAMI RD47:2020

    Reprocessing of hemodialyzers
    1/23/2020 - PDF - English - AAMI
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    €288.00

  • Medical Devices - A Practical Guide, Advice from ISO/TC 210 (13485:2016)

    Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
    1/22/2020 - Paper - English - AAMI
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    €219.00

  • Medical Devices - A Practical Guide, Advice from ISO/TC 210 (13485:2016)

    Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
    1/22/2020 - PDF - English - AAMI
    Learn More
    €154.00

  • AAMI/ISO 80369-1:2018

    Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
    12/30/2019 - Paper - English - AAMI
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    €215.00

  • AAMI/ISO 80369-1:2018

    Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
    12/30/2019 - PDF - English - AAMI
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    €151.00

  • AAMI/ISO 80369-3:2016/A1:2019

    Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment
    12/30/2019 - PDF - English - AAMI
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    €151.00

  • AAMI/ISO 23500-1:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements
    12/23/2019 - Paper - English - AAMI
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    €427.00

  • AAMI/ISO 23500-1:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements
    12/23/2019 - PDF - English - AAMI
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    €334.00

  • AAMI/ISO 23500-3:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
    12/23/2019 - Paper - English - AAMI
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    €256.00

  • AAMI/ISO 23500-3:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
    12/23/2019 - PDF - English - AAMI
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    €192.00

  • 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
    12/23/2019 - Paper - English - AAMI
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    €256.00

  • 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
    12/23/2019 - PDF - English - AAMI
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    €192.00

  • AAMI/ISO 23500-4:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
    12/23/2019 - Paper - English - AAMI
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    €314.00

  • AAMI/ISO 23500-4:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
    12/23/2019 - PDF - English - AAMI
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    €237.00

  • 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
    12/23/2019 - Paper - English - AAMI
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    €363.00

  • 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
    12/23/2019 - PDF - English - AAMI
    Learn More
    €270.00

  • AAMI CR500:2019

    Basic Introduction to the IEC 60601 Series
    12/18/2019 - Paper - English - AAMI
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    €256.00

  • AAMI CR500:2019

    Basic Introduction to the IEC 60601 Series
    12/18/2019 - PDF - English - AAMI
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    €192.00

  • AAMI ST72:2019

    Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
    11/1/2019 - Paper - English - AAMI
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    €381.00

  • AAMI ST72:2019

    Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing, Includes Erratum (2020)
    11/1/2019 - PDF - English - AAMI
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    €288.00

  • AAMI/ISO 11138-7:2019

    Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results
    11/1/2019 - Paper - English - AAMI
    Learn More
    €381.00

  • AAMI/ISO 11138-7:2019

    Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results
    11/1/2019 - PDF - English - AAMI
    Learn More
    €288.00

  • AAMI TIR97:2019

    Principles for medical device security - Postmarket risk management for device manufacturers
    9/27/2019 - Paper - English - AAMI
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    €381.00

  • AAMI TIR97:2019

    Principles for medical device security - Postmarket risk management for device manufacturers
    9/27/2019 - PDF - English - AAMI
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    €288.00

  • AAMI/ISO 14117:2019

    Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
    9/27/2019 - Paper - English - AAMI
    Learn More
    €427.00

  • AAMI/ISO 14117:2019

    Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
    9/27/2019 - PDF - English - AAMI
    Learn More
    €334.00

  • AAMI TIR102:2019

    U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
    8/30/2019 - Paper - English - AAMI
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    €427.00

  • AAMI TIR102:2019

    U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
    8/30/2019 - PDF - English - AAMI
    Learn More
    €334.00

  • AAMI ST67:2019

    Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
    7/29/2019 - Paper - English - AAMI
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    €220.00

  • AAMI ST67:2019

    Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
    7/29/2019 - PDF - English - AAMI
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    €155.00

  • AAMI/ISO 11737-2: 2019

    Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    7/11/2019 - Paper - English - AAMI
    Learn More
    €256.00

  • AAMI/ISO 11737-2: 2019

    Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    7/11/2019 - PDF - English - AAMI
    Learn More
    €192.00

  • ANSI/AAMI 2700-1:2019

    Medical Devices and Medical Systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
    7/1/2019 - Paper - English - AAMI
    Learn More
    €314.00

  • ANSI/AAMI 2700-1:2019

    Medical Devices and Medical Systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
    7/1/2019 - PDF - English - AAMI
    Learn More
    €237.00

  • AAMI TIR75:2019

    Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
    6/1/2019 - Paper - English - AAMI
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    €314.00

  • AAMI TIR75:2019

    Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
    6/1/2019 - PDF - English - AAMI
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    €237.00

  • AAMI/ISO 14971:2019

    Medical devices - Application of risk management to medical devices
    5/1/2019 - Paper - English - AAMI
    Learn More
    €381.00

  • AAMI/ISO 14971:2019

    Medical devices - Application of risk management to medical devices
    5/1/2019 - PDF - English - AAMI
    Learn More
    €288.00

  • AAMI/ISO 11137-1:2006 (R2015) A2:2019

    A2:2019 to Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
    5/1/2019 - PDF - English - AAMI
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    €128.00

  • AAMI EQ93:2019

    Medical equipment management - Vocabulary used in medical equipment programs
    4/18/2019 - Paper - English - AAMI
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    €199.00

  • AAMI EQ93:2019

    Medical equipment management - Vocabulary used in medical equipment programs
    4/18/2019 - PDF - English - AAMI
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    €135.00

  • AAMI/ISO 81060-2:2019

    Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
    3/22/2019 - Paper - English - AAMI
    Learn More
    €363.00

  • AAMI/ISO 81060-2:2019

    Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
    3/22/2019 - PDF - English - AAMI
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    €270.00

  • AAMI/IEC 60601-2-4:2010/A1:2018 (Consolidated Text)

    Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
    1/30/2019 - PDF - English - AAMI
    Learn More
    €334.00

  • AAMI/IEC 80601-2-30:2018:2019

    Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
    1/30/2019 - PDF - English - AAMI
    Learn More
    €279.00

  • AAMI TIR38:2019

    Medical device safety assurance case report guidance
    1/25/2019 - Paper - English - AAMI
    Learn More
    €381.00

  • AAMI TIR38:2019

    Medical device safety assurance case report guidance
    1/25/2019 - PDF - English - AAMI
    Learn More
    €288.00

  • AAMI/ISO 11607-1: 2019

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
    1/1/2019 - Paper - English - AAMI
    Learn More
    €256.00

  • AAMI/ISO 11607-1: 2019

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
    1/1/2019 - PDF - English - AAMI
    Learn More
    €192.00

  • AAMI/ISO 11607-2: 2019

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
    1/1/2019 - Paper - English - AAMI
    Learn More
    €220.00

  • AAMI/ISO 11607-2: 2019

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
    1/1/2019 - PDF - English - AAMI
    Learn More
    €155.00

  • AAMI SW91:2018

    Classification of defects in health software
    11/2/2018 - Paper - English - AAMI
    Learn More
    €381.00

  • AAMI SW91:2018

    Classification of defects in health software
    11/2/2018 - PDF - English - AAMI
    Learn More
    €288.00

  • AAMI HIT1000-1 (PS):2018

    Safety and effectiveness of health IT software and systems - Part 1: Fundamental concepts, principles, and requirements
    10/1/2018 - PDF - English - AAMI
    Learn More
    €0.00

  • AAMI TIR68:2018

    Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
    9/30/2018 - Paper - English - AAMI
    Learn More
    €251.00

  • AAMI/IEC 60601-2-20:2009 (R2014) & A1:2016

    Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
    9/1/2018 - PDF - English - AAMI
    Learn More
    €270.00

  • AAMI/IEC 60601-2-19:2009 (R2014) & A1:2016

    Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
    9/1/2018 - PDF - English - AAMI
    Learn More
    €237.00

  • AAMI/IEC 60601-2-21:2009 (R2014) & A1:2016

    Medical Electrical Equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
    9/1/2018 - PDF - English - AAMI
    Learn More
    €230.00

  • AAMI/IEC 60601-2-50:2009:2018 (R2014) & A1:2016

    Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
    9/1/2018 - PDF - English - AAMI
    Learn More
    €192.00

  • AAMI/ISO TI(R2190)0:2018

    Guidance for uncertainty analysis regarding the application of ISO/TS 10974
    7/19/2018 - Paper - English - AAMI
    Learn More
    €220.00

  • AAMI/ISO TI(R2190)0:2018

    Guidance for uncertainty analysis regarding the application of ISO/TS 10974
    7/19/2018 - PDF - English - AAMI
    Learn More
    €155.00

  • AAMI TIR77:2018

    Technical Information Report Sorbent-based regenerative hemodialysis systems
    6/8/2018 - Paper - English - AAMI
    Learn More
    €256.00

  • AAMI TIR77:2018

    Technical Information Report Sorbent-based regenerative hemodialysis systems
    6/8/2018 - PDF - English - AAMI
    Learn More
    €192.00

  • AAMI/ISO TI(R1097)4:2018

    Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
    5/1/2018 - Paper - English - AAMI
    Learn More
    €451.00

  • AAMI/ISO TI(R1097)4:2018

    Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
    5/1/2018 - PDF - English - AAMI
    Learn More
    €358.00

  • AAMI TIR67:2018 (R2022)

    Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
    4/25/2018 - Paper - English - AAMI
    Learn More
    €390.00

  • AAMI TIR67:2018 (R2022)

    Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
    4/25/2018 - PDF - English - AAMI
    Learn More
    €297.00

  • AAMI TIR40:2018

    Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
    1/31/2018 - Paper - English - AAMI
    Learn More
    €256.00

  • AAMI TIR40:2018

    Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
    1/31/2018 - PDF - English - AAMI
    Learn More
    €192.00

  • AAMI/ISO 11737-1:2018

    Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
    1/24/2018 - Paper - English - AAMI
    Learn More
    €269.00

  • AAMI/ISO 11737-1:2018

    Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
    1/24/2018 - PDF - English - AAMI
    Learn More
    €205.00

  • AAMI TIR16:2017 (R2020)

    162
    11/17/2017 - Paper - English - AAMI
    Learn More
    €256.00

  • AAMI TIR16:2017 (R2020)

    Microbiological aspects of ethylene oxide sterilization
    11/17/2017 - PDF - English - AAMI
    Learn More
    €192.00

  • AAMI/ISO 13408-2:2018

    Aseptic processing of health care products - Part 2:Sterilizing filtration
    11/17/2017 - Paper - English - AAMI
    Learn More
    €220.00

  • AAMI/ISO 13408-2:2018

    Aseptic processing of health care products - Part 2:Sterilizing filtration
    11/17/2017 - PDF - English - AAMI
    Learn More
    €155.00

  • AAMI/ISO 11137-3:2017

    Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine
    10/6/2017 - Paper - English - AAMI
    Learn More
    €220.00

  • AAMI/ISO 11137-3:2017

    Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine
    10/6/2017 - PDF - English - AAMI
    Learn More
    €155.00

  • AAMI ST79:2017

    Comprehensive guide to steam sterilization and sterility assurance in health care facilities with Amendments A1:2020, A2:2020, A3:2020, A4:2020
    10/1/2017 - Paper - English - AAMI
    Learn More
    €576.00

  • AAMI ST79:2017

    Comprehensive guide to steam sterilization and sterility assurance in health care facilities

    with amendments A1:2020, A2:2020, A3:2020, A4:2020
    10/1/2017 - PDF - English - AAMI
    Learn More
    €483.00

  • AAMI/ISO 80369-7:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
    9/27/2017 - Paper - English - AAMI
    Learn More
    €381.00

  • AAMI/ISO 80369-7:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
    9/27/2017 - PDF - English - AAMI
    Learn More
    €288.00

  • AAMI TIR72:2017

    Dialysis fluid chemical composition
    9/8/2017 - Paper - English - AAMI
    Learn More
    €220.00

  • AAMI TIR72:2017

    Dialysis fluid chemical composition
    9/8/2017 - PDF - English - AAMI
    Learn More
    €155.00

  • AAMI/ISO TI(R1549)9:2017

    Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
    8/27/2017 - Paper - English - AAMI
    Learn More
    €251.00

  • AAMI/ISO TI(R1549)9:2017

    Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
    8/27/2017 - PDF - English - AAMI
    Learn More
    €186.00

  • AAMI/ISO 17664:2017

    Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
    8/18/2017 - Paper - English - AAMI
    Learn More
    €314.00

  • AAMI/ISO 17664:2017

    Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
    8/18/2017 - PDF - English - AAMI
    Learn More
    €237.00

  • AAMI/ISO TIR80002-2:2017

    Medical device software - Part 2: Validation of software for medical device quality systems
    8/18/2017 - PDF - English, French - AAMI
    Learn More
    €334.00

  • AAMI TIR71:2017 (R2020)

    Guidance for logging of alarm system data
    8/11/2017 - Paper - English - AAMI
    Learn More
    €220.00

  • AAMI TIR71:2017 (R2020)

    Guidance for logging of alarm system data
    8/11/2017 - PDF - English - AAMI
    Learn More
    €155.00

  • AAMI TIR59:2017

    Integrating human factors into design controls
    8/4/2017 - Paper - English - AAMI
    Learn More
    €314.00

  • AAMI TIR59:2017

    Integrating human factors into design controls
    8/4/2017 - PDF - English - AAMI
    Learn More
    €237.00

  • AAMI/ISO 11138-1:2017

    Sterilization of health care products - Biological indicators - Part 1: General requirements
    8/1/2017 - Paper - English - AAMI
    Learn More
    €381.00

  • AAMI/ISO 11138-1:2017

    Sterilization of health care products - Biological indicators - Part 1: General requirements
    8/1/2017 - PDF - English - AAMI
    Learn More
    €288.00

  • AAMI/ISO 11138-5:2017

    Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
    8/1/2017 - Paper - English - AAMI
    Learn More
    €199.00

  • AAMI/ISO 11138-5:2017

    Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
    8/1/2017 - PDF - English - AAMI
    Learn More
    €135.00

  • AAMI/ISO 11138-2:2017

    Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
    8/1/2017 - Paper - English - AAMI
    Learn More
    €199.00

  • AAMI/ISO 11138-2:2017

    Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
    8/1/2017 - PDF - English - AAMI
    Learn More
    €135.00

  • AAMI/ISO 11138-4:2017

    Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
    8/1/2017 - Paper - English - AAMI
    Learn More
    €199.00

  • AAMI/ISO 11138-4:2017

    Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
    8/1/2017 - PDF - English - AAMI
    Learn More
    €135.00

  • AAMI/ISO 11138-3:2017

    Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
    8/1/2017 - Paper - English - AAMI
    Learn More
    €199.00

  • AAMI/ISO 11138-3:2017

    Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
    8/1/2017 - PDF - English - AAMI
    Learn More
    €135.00

  • AAMI/ISO 16142-2:2017

    Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
    7/31/2017 - Paper - English - AAMI
    Learn More
    €381.00

  • AAMI/ISO 16142-2:2017

    Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
    7/31/2017 - PDF - English - AAMI
    Learn More
    €288.00

  • AAMI ST90:2017

    Processing of health care products - Quality management systems for processing in health care facilities
    7/18/2017 - Paper - English - AAMI
    Learn More
    €363.00

  • AAMI ST90:2017

    Processing of health care products - Quality management systems for processing in health care facilities
    7/18/2017 - PDF - English - AAMI
    Learn More
    €270.00

  • AAMI/IEC 60601-2-2:2017

    Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
    6/30/2017 - PDF - English - AAMI
    Learn More
    €288.00

  • AAMI TIR17:2017

    Compatibility of materials subject to sterilization
    6/11/2017 - Paper - English - AAMI
    Learn More
    €400.00

  • AAMI TIR17:2017

    Compatibility of materials subject to sterilization
    6/11/2017 - PDF - English - AAMI
    Learn More
    €307.00

  • AAMI TIR21:2017 (R2020)

    Systems Used to Forecast Remaining Pacemaker Battery Service Life
    6/11/2017 - Paper - English - AAMI
    Learn More
    €381.00

  • AAMI TIR21:2017 (R2020)

    Systems Used to Forecast Remaining Pacemaker Battery Service Life
    6/11/2017 - PDF - English - AAMI
    Learn More
    €288.00

  • AAMI RT2:2017

    Radiation therapy readiness check
    6/1/2017 - PDF - English - AAMI
    Learn More
    €0.00

  • AAMI/ISO 25539-1:2017

    Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
    5/25/2017 - Paper - English - AAMI
    Learn More
    €314.00

  • AAMI/ISO 25539-1:2017

    Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
    5/25/2017 - PDF - English - AAMI
    Learn More
    €237.00

  • AAMI TIR69:2017 (R2020)

    Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
    4/28/2017 - Paper - English - AAMI
    Learn More
    €381.00

  • AAMI TIR69:2017 (R2020)

    Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
    4/28/2017 - PDF - English - AAMI
    Learn More
    €288.00

  • AAMI/ISO 14708-3:2017

    Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
    3/2/2017 - Paper - English - AAMI
    Learn More
    €363.00

  • AAMI/ISO 14708-3:2017

    Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
    3/2/2017 - PDF - English - AAMI
    Learn More
    €270.00

  • AAMI TIR66:2017 (R2020)

    Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
    2/28/2017 - Paper - English - AAMI
    Learn More
    €314.00

  • AAMI TIR66:2017 (R2020)

    Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
    2/28/2017 - PDF - English - AAMI
    Learn More
    €237.00

  • ANSI/AAMI/ISO 10993-6:2016

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
    1/10/2017 - Paper - English - AAMI
    Learn More
    €256.00

  • ANSI/AAMI/ISO 10993-6:2016

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
    1/10/2017 - PDF - English - AAMI
    Learn More
    €192.00

  • AAMI CI86:2017

    Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
    1/6/2017 - Paper - English - AAMI
    Learn More
    €427.00

  • AAMI CI86:2017

    Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
    1/6/2017 - PDF - English - AAMI
    Learn More
    €334.00

  • AAMI/ISO 15223-1:2016

    Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
    12/15/2016 - Paper - English - AAMI
    Learn More
    €256.00

  • AAMI/ISO 15223-1:2016

    Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
    12/15/2016 - PDF - English - AAMI
    Learn More
    €192.00

  • AAMI TIR15:2016 (R2020)

    Physical aspects of ethylene oxide sterilization
    11/18/2016 - Paper - English - AAMI
    Learn More
    €256.00

  • AAMI TIR15:2016 (R2020)

    Physical aspects of ethylene oxide sterilization
    11/18/2016 - PDF - English - AAMI
    Learn More
    €192.00

  • AAMI/IEC TIR80001-2-8:2016

    Application of risk management for IT networks incorporating medical devices - Part 2-8: Application guidance Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
    11/18/2016 - Paper - English - AAMI
    Learn More
    €381.00

  • AAMI/IEC TIR80001-2-8:2016

    Application of risk management for IT networks incorporating medical devices - Part 2-8: Application guidance Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
    11/18/2016 - PDF - English - AAMI
    Learn More
    €288.00

  • AAMI/ISO 7199:2016

    Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
    11/18/2016 - Paper - English - AAMI
    Learn More
    €220.00

  • AAMI/ISO 7199:2016

    Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
    11/18/2016 - PDF - English - AAMI
    Learn More
    €155.00

  • AAMI/ISO 15676:2016

    Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
    11/18/2016 - Paper - English - AAMI
    Learn More
    €220.00

  • AAMI/ISO 15675:2016

    Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
    11/18/2016 - Paper - English - AAMI
    Learn More
    €199.00

  • AAMI/ISO 15675:2016

    Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
    11/18/2016 - PDF - English - AAMI
    Learn More
    €135.00

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