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  • AAMI ST44 : 2002

    Resistometers used for characterizing the performance of biological and chemical indicators
    10.07.2022 - PDF - Englisch - AAMI
    mehr dazu
    89,00 €

  • AAMI 2800-1-2:2022

    Standard for Interoperable Item Development Life Cycle (ANSI/AAMI/UL 2800-1-2:2022)
    10.06.2022 - Paper - Englisch - AAMI
    mehr dazu
    359,00 €

  • AAMI 2800-1-2:2022

    Standard for Interoperable Item Development Life Cycle (ANSI/AAMI/UL 2800-1-2:2022)
    10.06.2022 - PDF - Englisch - AAMI
    mehr dazu
    269,00 €

  • AAMI 2800-1:2022

    Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2022)
    10.06.2022 - Paper - Englisch - AAMI
    mehr dazu
    422,00 €

  • AAMI 2800-1:2022

    Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2022)
    10.06.2022 - PDF - Englisch - AAMI
    mehr dazu
    332,00 €

  • AAMI 2800-1-3:2022

    Standard for Interoperable Item Integration Life Cycle (ANSI/AAMI/UL 2800-1-3:2022)
    10.06.2022 - Paper - Englisch - AAMI
    mehr dazu
    325,00 €

  • AAMI 2800-1-3:2022

    Standard for Interoperable Item Integration Life Cycle (ANSI/AAMI/UL 2800-1-3:2022)
    10.06.2022 - PDF - Englisch - AAMI
    mehr dazu
    235,00 €

  • AAMI 2800-1-1:2022

    Standard for Risk Concerns for Interoperable Medical Products (ANSI/AAMI/UL 2800-1-1:2022)
    10.06.2022 - Paper - Englisch - AAMI
    mehr dazu
    376,00 €

  • AAMI 2800-1-1:2022

    Standard for Risk Concerns for Interoperable Medical Products (ANSI/AAMI/UL 2800-1-1:2022)
    10.06.2022 - PDF - Englisch - AAMI
    mehr dazu
    286,00 €

  • AAMI TIR100: 2021:2022

    End-to-end microbiological quality and sterility assurance
    10.05.2022 - Paper - Englisch - AAMI
    mehr dazu
    253,00 €

  • AAMI TIR100: 2021:2022

    End-to-end microbiological quality and sterility assurance
    10.05.2022 - PDF - Englisch - AAMI
    mehr dazu
    191,00 €

  • 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
    22.04.2022 - Paper - Englisch - AAMI
    mehr dazu
    359,00 €

  • 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
    22.04.2022 - PDF - Englisch - AAMI
    mehr dazu
    269,00 €

  • AAMI TIR104:2022

    Guidance on transferring health care products between radiation sterilization sources
    19.04.2022 - Paper - Englisch - AAMI
    mehr dazu
    325,00 €

  • AAMI TIR104:2022

    Guidance on transferring health care products between radiation sterilization sources
    19.04.2022 - PDF - Englisch - AAMI
    mehr dazu
    235,00 €

  • AAMI CR34971:2022

    Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
    01.04.2022 - Paper - Englisch - AAMI
    mehr dazu
    325,00 €

  • AAMI CR34971:2022

    Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
    01.04.2022 - PDF - Englisch - AAMI
    mehr dazu
    235,00 €

  • 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)
    20.03.2022 - Paper - Englisch - AAMI
    mehr dazu
    192,00 €

  • 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)
    20.03.2022 - PDF - Englisch - AAMI
    mehr dazu
    130,00 €

  • 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)
    01.03.2022 - Paper - Englisch - AAMI
    mehr dazu
    367,00 €

  • 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)
    01.03.2022 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • AAMI HIT1000-1: 2022:2022

    Safety and effectiveness of health IT software and systems-Part 1: Fundamental concepts, principles, and requirements
    01.03.2022 - Paper - Englisch - AAMI
    mehr dazu
    359,00 €

  • AAMI HIT1000-1: 2022:2022

    Safety and effectiveness of health IT software and systems-Part 1: Fundamental concepts, principles, and requirements
    01.03.2022 - PDF - Englisch - AAMI
    mehr dazu
    269,00 €

  • AAMI ST91:2021

    Flexible and semi-rigid endoscope processing in health care facilities
    21.12.2021 - Paper - Englisch - AAMI
    mehr dazu
    473,00 €

  • AAMI ST91:2021

    Flexible and semi-rigid endoscope processing in health care facilities
    21.12.2021 - PDF - Englisch - AAMI
    mehr dazu
    384,00 €

  • AAMI TIR 101:2021

    Fluid delivery performance testing for infusion pumps
    15.10.2021 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • AAMI CR510:2021

    Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
    24.09.2021 - PDF - Englisch - AAMI
    mehr dazu
    130,00 €

  • AAMI PC76:2021

    Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
    01.04.2021 - PDF - Englisch - AAMI
    mehr dazu
    313,00 €

  • AAMI TIR42:2021

    Evaluation of particulate associated with vascular medical devices
    31.03.2021 - PDF - Englisch - AAMI
    mehr dazu
    261,00 €

  • 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
    31.03.2021 - PDF - Englisch - AAMI
    mehr dazu
    261,00 €

  • AAMI TIR43:2021

    Ultrapure dialysis fluid for hemodialysis and related therapies
    26.02.2021 - PDF - Englisch - AAMI
    mehr dazu
    261,00 €

  • AAMI/ISO 14155:2020

    Clinical investigation of medical devices for human subjects - Good clinical practice
    07.12.2020 - PDF - Englisch - AAMI
    mehr dazu
    322,00 €

  • AAMI/ISO 10993-16:2017:2020

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
    06.11.2020 - PDF - Englisch - AAMI
    mehr dazu
    150,00 €

  • AAMI/ISO 10993-15:2019:2020

    Biological evaluation of medical devices?Part 15: Identification and quantification of degradation products from metals and alloys
    05.10.2020 - PDF - Englisch - AAMI
    mehr dazu
    150,00 €

  • AAMI TIR12:2020

    Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
    17.09.2020 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • AAMI TIR105:2020

    Risk management guidance for combination products
    10.09.2020 - PDF - Englisch - AAMI
    mehr dazu
    261,00 €

  • 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
    26.08.2020 - PDF - Englisch - AAMI
    mehr dazu
    229,00 €

  • 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
    03.08.2020 - PDF - Englisch - AAMI
    mehr dazu
    250,00 €

  • 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
    22.07.2020 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • AAMI HIT1000-4 (PS):2020

    Safety and effectiveness of health IT software and systems - Part 4: Application of human factors engineering
    07.07.2020 - PDF - Englisch - AAMI
    mehr dazu
    24,00 €

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

    Medical devices - Part 1: Application of usability engineering to medical devices, including Amendment 1
    01.07.2020 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • AAMI/ISO 8637-1:2017:2020

    Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
    01.07.2020 - PDF - Englisch - AAMI
    mehr dazu
    229,00 €

  • AAMI/ISO 8637-3:2018:2020

    Extracorporeal systems for blood purification - Part 3: Plasmafilters
    01.07.2020 - PDF - Englisch - AAMI
    mehr dazu
    185,00 €

  • AAMI/ISO 8637-2:2018:2020

    Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
    01.07.2020 - PDF - Englisch - AAMI
    mehr dazu
    185,00 €

  • AAMI/ISO 10993-4:2017

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
    27.04.2020 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • AAMI/ISO 10993-1:2018

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
    27.04.2020 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • AAMI/ISO 10993-11:2017

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
    27.04.2020 - PDF - Englisch - AAMI
    mehr dazu
    229,00 €

  • AAMI MP80601-2-49:2020

    Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
    24.03.2020 - PDF - Englisch - AAMI
    mehr dazu
    261,00 €

  • AAMI RT3: 2020

    Radiation therapy machine characterization
    21.02.2020 - Paper - Englisch - AAMI
    mehr dazu
    42,00 €

  • AAMI RT3: 2020

    Radiation therapy machine characterization
    21.02.2020 - PDF - Englisch - AAMI
    mehr dazu
    0,00 €

  • AAMI/ISO TI (R2041)6:2020

    Medical devices - Post-market surveillance for manufacturers
    16.02.2020 - PDF - Englisch - AAMI
    mehr dazu
    270,00 €

  • AAMI/ISO TI (R2497)1:2020

    Medical devices - Guidance on the application of ISO 14971
    02.02.2020 - PDF - Englisch - AAMI
    mehr dazu
    322,00 €

  • AAMI RD47:2020

    Reprocessing of hemodialyzers
    23.01.2020 - Paper - Englisch - AAMI
    mehr dazu
    367,00 €

  • AAMI RD47:2020

    Reprocessing of hemodialyzers
    23.01.2020 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • 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
    22.01.2020 - Paper - Englisch - AAMI
    mehr dazu
    211,00 €

  • 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
    22.01.2020 - PDF - Englisch - AAMI
    mehr dazu
    149,00 €

  • AAMI/ISO 80369-1:2018

    Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
    30.12.2019 - Paper - Englisch - AAMI
    mehr dazu
    208,00 €

  • AAMI/ISO 80369-1:2018

    Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
    30.12.2019 - PDF - Englisch - AAMI
    mehr dazu
    145,00 €

  • AAMI/ISO 80369-3:2016/A1:2019

    Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment
    30.12.2019 - PDF - Englisch - AAMI
    mehr dazu
    145,00 €

  • AAMI/ISO 23500-1:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements
    23.12.2019 - Paper - Englisch - AAMI
    mehr dazu
    412,00 €

  • AAMI/ISO 23500-1:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements
    23.12.2019 - PDF - Englisch - AAMI
    mehr dazu
    322,00 €

  • AAMI/ISO 23500-3:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
    23.12.2019 - Paper - Englisch - AAMI
    mehr dazu
    248,00 €

  • AAMI/ISO 23500-3:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
    23.12.2019 - PDF - Englisch - AAMI
    mehr dazu
    185,00 €

  • 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
    23.12.2019 - Paper - Englisch - AAMI
    mehr dazu
    248,00 €

  • 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
    23.12.2019 - PDF - Englisch - AAMI
    mehr dazu
    185,00 €

  • AAMI/ISO 23500-4:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
    23.12.2019 - Paper - Englisch - AAMI
    mehr dazu
    303,00 €

  • AAMI/ISO 23500-4:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
    23.12.2019 - PDF - Englisch - AAMI
    mehr dazu
    229,00 €

  • 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
    23.12.2019 - Paper - Englisch - AAMI
    mehr dazu
    351,00 €

  • 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
    23.12.2019 - PDF - Englisch - AAMI
    mehr dazu
    261,00 €

  • AAMI CR500:2019

    Basic Introduction to the IEC 60601 Series
    18.12.2019 - Paper - Englisch - AAMI
    mehr dazu
    248,00 €

  • AAMI CR500:2019

    Basic Introduction to the IEC 60601 Series
    18.12.2019 - PDF - Englisch - AAMI
    mehr dazu
    185,00 €

  • AAMI ST72:2019

    Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
    01.11.2019 - Paper - Englisch - AAMI
    mehr dazu
    367,00 €

  • AAMI ST72:2019

    Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing, Includes Erratum (2020)
    01.11.2019 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • AAMI/ISO 11138-7:2019

    Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results
    01.11.2019 - Paper - Englisch - AAMI
    mehr dazu
    367,00 €

  • AAMI/ISO 11138-7:2019

    Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results
    01.11.2019 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • AAMI TIR97:2019

    Principles for medical device security - Postmarket risk management for device manufacturers
    27.09.2019 - Paper - Englisch - AAMI
    mehr dazu
    367,00 €

  • AAMI TIR97:2019

    Principles for medical device security - Postmarket risk management for device manufacturers
    27.09.2019 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • AAMI/ISO 14117:2019

    Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
    27.09.2019 - Paper - Englisch - AAMI
    mehr dazu
    412,00 €

  • AAMI/ISO 14117:2019

    Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
    27.09.2019 - PDF - Englisch - AAMI
    mehr dazu
    322,00 €

  • AAMI TIR102:2019

    U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
    30.08.2019 - Paper - Englisch - AAMI
    mehr dazu
    412,00 €

  • AAMI TIR102:2019

    U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
    30.08.2019 - PDF - Englisch - AAMI
    mehr dazu
    322,00 €

  • AAMI ST67:2019

    Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
    29.07.2019 - Paper - Englisch - AAMI
    mehr dazu
    212,00 €

  • AAMI ST67:2019

    Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
    29.07.2019 - PDF - Englisch - AAMI
    mehr dazu
    150,00 €

  • 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
    11.07.2019 - Paper - Englisch - AAMI
    mehr dazu
    248,00 €

  • 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
    11.07.2019 - PDF - Englisch - AAMI
    mehr dazu
    185,00 €

  • 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
    01.07.2019 - Paper - Englisch - AAMI
    mehr dazu
    303,00 €

  • 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
    01.07.2019 - PDF - Englisch - AAMI
    mehr dazu
    229,00 €

  • AAMI TIR75:2019

    Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
    01.06.2019 - Paper - Englisch - AAMI
    mehr dazu
    303,00 €

  • AAMI TIR75:2019

    Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
    01.06.2019 - PDF - Englisch - AAMI
    mehr dazu
    229,00 €

  • AAMI/ISO 14971:2019

    Medical devices - Application of risk management to medical devices
    01.05.2019 - Paper - Englisch - AAMI
    mehr dazu
    367,00 €

  • AAMI/ISO 14971:2019

    Medical devices - Application of risk management to medical devices
    01.05.2019 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • 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
    01.05.2019 - PDF - Englisch - AAMI
    mehr dazu
    123,00 €

  • AAMI EQ93:2019

    Medical equipment management - Vocabulary used in medical equipment programs
    18.04.2019 - Paper - Englisch - AAMI
    mehr dazu
    192,00 €

  • AAMI EQ93:2019

    Medical equipment management - Vocabulary used in medical equipment programs
    18.04.2019 - PDF - Englisch - AAMI
    mehr dazu
    130,00 €

  • AAMI/ISO 81060-2:2019

    Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
    22.03.2019 - Paper - Englisch - AAMI
    mehr dazu
    351,00 €

  • AAMI/ISO 81060-2:2019

    Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
    22.03.2019 - PDF - Englisch - AAMI
    mehr dazu
    261,00 €

  • 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
    30.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    322,00 €

  • 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
    30.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    249,08 €

  • AAMI TIR38:2019

    Medical device safety assurance case report guidance
    25.01.2019 - Paper - Englisch - AAMI
    mehr dazu
    367,00 €

  • AAMI TIR38:2019

    Medical device safety assurance case report guidance
    25.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • AAMI/ISO 11607-1: 2019

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
    01.01.2019 - Paper - Englisch - AAMI
    mehr dazu
    248,00 €

  • AAMI/ISO 11607-1: 2019

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    185,00 €

  • AAMI/ISO 11607-2: 2019

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
    01.01.2019 - Paper - Englisch - AAMI
    mehr dazu
    212,00 €

  • AAMI/ISO 11607-2: 2019

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    150,00 €

  • AAMI SW91:2018

    Classification of defects in health software
    02.11.2018 - Paper - Englisch - AAMI
    mehr dazu
    341,00 €

  • AAMI SW91:2018

    Classification of defects in health software
    02.11.2018 - PDF - Englisch - AAMI
    mehr dazu
    258,00 €

  • AAMI HIT1000-1 (PS):2018

    Safety and effectiveness of health IT software and systems - Part 1: Fundamental concepts, principles, and requirements
    01.10.2018 - PDF - Englisch - AAMI
    mehr dazu
    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
    30.09.2018 - Paper - Englisch - AAMI
    mehr dazu
    226,72 €

  • 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
    01.09.2018 - PDF - Englisch - AAMI
    mehr dazu
    261,00 €

  • 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
    01.09.2018 - PDF - Englisch - AAMI
    mehr dazu
    229,00 €

  • 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
    01.09.2018 - PDF - Englisch - AAMI
    mehr dazu
    205,00 €

  • 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
    01.09.2018 - PDF - Englisch - AAMI
    mehr dazu
    185,00 €

  • AAMI/ISO TI(R2190)0:2018

    Guidance for uncertainty analysis regarding the application of ISO/TS 10974
    19.07.2018 - Paper - Englisch - AAMI
    mehr dazu
    212,00 €

  • AAMI/ISO TI(R2190)0:2018

    Guidance for uncertainty analysis regarding the application of ISO/TS 10974
    19.07.2018 - PDF - Englisch - AAMI
    mehr dazu
    150,00 €

  • AAMI TIR77:2018

    Technical Information Report Sorbent-based regenerative hemodialysis systems
    08.06.2018 - Paper - Englisch - AAMI
    mehr dazu
    248,00 €

  • AAMI TIR77:2018

    Technical Information Report Sorbent-based regenerative hemodialysis systems
    08.06.2018 - PDF - Englisch - AAMI
    mehr dazu
    185,00 €

  • AAMI/ISO TI(R1097)4:2018

    Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
    01.05.2018 - Paper - Englisch - AAMI
    mehr dazu
    435,00 €

  • AAMI/ISO TI(R1097)4:2018

    Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
    01.05.2018 - PDF - Englisch - AAMI
    mehr dazu
    345,00 €

  • AAMI TIR67:2018 (R2022)

    Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
    25.04.2018 - Paper - Englisch - AAMI
    mehr dazu
    376,00 €

  • AAMI TIR67:2018 (R2022)

    Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
    25.04.2018 - PDF - Englisch - AAMI
    mehr dazu
    286,00 €

  • AAMI TIR40:2018

    Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
    31.01.2018 - Paper - Englisch - AAMI
    mehr dazu
    248,00 €

  • AAMI TIR40:2018

    Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
    31.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    185,00 €

  • AAMI/ISO 11737-1:2018

    Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
    24.01.2018 - Paper - Englisch - AAMI
    mehr dazu
    260,00 €

  • AAMI/ISO 11737-1:2018

    Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
    24.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    198,00 €

  • AAMI TIR16:2017 (R2020)

    162
    17.11.2017 - Paper - Englisch - AAMI
    mehr dazu
    248,00 €

  • AAMI TIR16:2017 (R2020)

    Microbiological aspects of ethylene oxide sterilization
    17.11.2017 - PDF - Englisch - AAMI
    mehr dazu
    185,00 €

  • AAMI/ISO 13408-2:2018

    Aseptic processing of health care products - Part 2:Sterilizing filtration
    17.11.2017 - Paper - Englisch - AAMI
    mehr dazu
    212,00 €

  • AAMI/ISO 13408-2:2018

    Aseptic processing of health care products - Part 2:Sterilizing filtration
    17.11.2017 - PDF - Englisch - AAMI
    mehr dazu
    150,00 €

  • AAMI/ISO 11137-3:2017

    Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine
    06.10.2017 - Paper - Englisch - AAMI
    mehr dazu
    212,00 €

  • AAMI/ISO 11137-3:2017

    Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine
    06.10.2017 - PDF - Englisch - AAMI
    mehr dazu
    150,00 €

  • 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
    01.10.2017 - Paper - Englisch - AAMI
    mehr dazu
    516,00 €

  • 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
    01.10.2017 - PDF - Englisch - AAMI
    mehr dazu
    433,00 €

  • AAMI/ISO 80369-7:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
    27.09.2017 - Paper - Englisch - AAMI
    mehr dazu
    367,00 €

  • AAMI/ISO 80369-7:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
    27.09.2017 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • AAMI TIR72:2017

    Dialysis fluid chemical composition
    08.09.2017 - Paper - Englisch - AAMI
    mehr dazu
    212,00 €

  • AAMI TIR72:2017

    Dialysis fluid chemical composition
    08.09.2017 - PDF - Englisch - AAMI
    mehr dazu
    150,00 €

  • AAMI/ISO TI(R1549)9:2017

    Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
    27.08.2017 - Paper - Englisch - AAMI
    mehr dazu
    242,00 €

  • AAMI/ISO TI(R1549)9:2017

    Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
    27.08.2017 - PDF - Englisch - AAMI
    mehr dazu
    180,00 €

  • AAMI/ISO 17664:2017

    Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
    18.08.2017 - Paper - Englisch - AAMI
    mehr dazu
    303,00 €

  • AAMI/ISO 17664:2017

    Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
    18.08.2017 - PDF - Englisch - AAMI
    mehr dazu
    229,00 €

  • AAMI/ISO TIR80002-2:2017

    Medical device software - Part 2: Validation of software for medical device quality systems
    18.08.2017 - PDF - Englisch, Französisch - AAMI
    mehr dazu
    322,00 €

  • AAMI TIR71:2017 (R2020)

    Guidance for logging of alarm system data
    11.08.2017 - Paper - Englisch - AAMI
    mehr dazu
    198,64 €

  • AAMI TIR71:2017 (R2020)

    Guidance for logging of alarm system data
    11.08.2017 - PDF - Englisch - AAMI
    mehr dazu
    138,38 €

  • AAMI TIR59:2017

    Integrating human factors into design controls
    04.08.2017 - Paper - Englisch - AAMI
    mehr dazu
    303,00 €

  • AAMI TIR59:2017

    Integrating human factors into design controls
    04.08.2017 - PDF - Englisch - AAMI
    mehr dazu
    229,00 €

  • AAMI/ISO 11138-1:2017

    Sterilization of health care products - Biological indicators - Part 1: General requirements
    01.08.2017 - Paper - Englisch - AAMI
    mehr dazu
    367,00 €

  • AAMI/ISO 11138-1:2017

    Sterilization of health care products - Biological indicators - Part 1: General requirements
    01.08.2017 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • AAMI/ISO 11138-5:2017

    Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
    01.08.2017 - Paper - Englisch - AAMI
    mehr dazu
    192,00 €

  • AAMI/ISO 11138-5:2017

    Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
    01.08.2017 - PDF - Englisch - AAMI
    mehr dazu
    130,00 €

  • AAMI/ISO 11138-2:2017

    Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
    01.08.2017 - Paper - Englisch - AAMI
    mehr dazu
    192,00 €

  • AAMI/ISO 11138-2:2017

    Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
    01.08.2017 - PDF - Englisch - AAMI
    mehr dazu
    130,00 €

  • AAMI/ISO 11138-4:2017

    Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
    01.08.2017 - Paper - Englisch - AAMI
    mehr dazu
    192,00 €

  • AAMI/ISO 11138-4:2017

    Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
    01.08.2017 - PDF - Englisch - AAMI
    mehr dazu
    130,00 €

  • AAMI/ISO 11138-3:2017

    Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
    01.08.2017 - Paper - Englisch - AAMI
    mehr dazu
    192,00 €

  • AAMI/ISO 11138-3:2017

    Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
    01.08.2017 - PDF - Englisch - AAMI
    mehr dazu
    130,00 €

  • 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
    31.07.2017 - Paper - Englisch - AAMI
    mehr dazu
    367,00 €

  • 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
    31.07.2017 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • AAMI ST90:2017

    Processing of health care products - Quality management systems for processing in health care facilities
    18.07.2017 - Paper - Englisch - AAMI
    mehr dazu
    328,64 €

  • AAMI ST90:2017

    Processing of health care products - Quality management systems for processing in health care facilities
    18.07.2017 - PDF - Englisch - AAMI
    mehr dazu
    240,88 €

  • 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
    30.06.2017 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • AAMI TIR17:2017

    Compatibility of materials subject to sterilization
    11.06.2017 - Paper - Englisch - AAMI
    mehr dazu
    358,00 €

  • AAMI TIR17:2017

    Compatibility of materials subject to sterilization
    11.06.2017 - PDF - Englisch - AAMI
    mehr dazu
    275,00 €

  • AAMI TIR21:2017 (R2020)

    Systems Used to Forecast Remaining Pacemaker Battery Service Life
    11.06.2017 - Paper - Englisch - AAMI
    mehr dazu
    344,24 €

  • AAMI TIR21:2017 (R2020)

    Systems Used to Forecast Remaining Pacemaker Battery Service Life
    11.06.2017 - PDF - Englisch - AAMI
    mehr dazu
    256,25 €

  • AAMI RT2:2017

    Radiation therapy readiness check
    01.06.2017 - PDF - Englisch - AAMI
    mehr dazu
    0,00 €

  • AAMI/ISO 25539-1:2017

    Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
    25.05.2017 - Paper - Englisch - AAMI
    mehr dazu
    303,00 €

  • AAMI/ISO 25539-1:2017

    Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
    25.05.2017 - PDF - Englisch - AAMI
    mehr dazu
    229,00 €

  • AAMI TIR69:2017 (R2020)

    Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
    28.04.2017 - Paper - Englisch - AAMI
    mehr dazu
    344,24 €

  • AAMI TIR69:2017 (R2020)

    Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
    28.04.2017 - PDF - Englisch - AAMI
    mehr dazu
    256,25 €

  • AAMI/ISO 14708-3:2017

    Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
    02.03.2017 - Paper - Englisch - AAMI
    mehr dazu
    351,00 €

  • AAMI/ISO 14708-3:2017

    Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
    02.03.2017 - PDF - Englisch - AAMI
    mehr dazu
    261,00 €

  • 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
    28.02.2017 - Paper - Englisch - AAMI
    mehr dazu
    283,92 €

  • 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
    28.02.2017 - PDF - Englisch - AAMI
    mehr dazu
    211,15 €

  • ANSI/AAMI/ISO 10993-6:2016

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
    10.01.2017 - Paper - Englisch - AAMI
    mehr dazu
    248,00 €

  • ANSI/AAMI/ISO 10993-6:2016

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
    10.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    185,00 €

  • AAMI CI86:2017

    Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
    06.01.2017 - Paper - Englisch - AAMI
    mehr dazu
    412,00 €

  • AAMI CI86:2017

    Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
    06.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    322,00 €

  • 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
    15.12.2016 - Paper - Englisch - AAMI
    mehr dazu
    248,00 €

  • 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
    15.12.2016 - PDF - Englisch - AAMI
    mehr dazu
    185,00 €

  • AAMI TIR15:2016 (R2020)

    Physical aspects of ethylene oxide sterilization
    18.11.2016 - Paper - Englisch - AAMI
    mehr dazu
    248,00 €

  • AAMI TIR15:2016 (R2020)

    Physical aspects of ethylene oxide sterilization
    18.11.2016 - PDF - Englisch - AAMI
    mehr dazu
    185,00 €

  • 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
    18.11.2016 - Paper - Englisch - AAMI
    mehr dazu
    367,00 €

  • 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
    18.11.2016 - PDF - Englisch - AAMI
    mehr dazu
    278,00 €

  • AAMI/ISO 7199:2016

    Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
    18.11.2016 - Paper - Englisch - AAMI
    mehr dazu
    212,00 €

  • AAMI/ISO 7199:2016

    Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
    18.11.2016 - PDF - Englisch - AAMI
    mehr dazu
    150,00 €

  • AAMI/ISO 15676:2016

    Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
    18.11.2016 - Paper - Englisch - AAMI
    mehr dazu
    212,00 €

  • AAMI/ISO 15675:2016

    Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
    18.11.2016 - Paper - Englisch - AAMI
    mehr dazu
    192,00 €

  • AAMI/ISO 15675:2016

    Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
    18.11.2016 - PDF - Englisch - AAMI
    mehr dazu
    130,00 €

  • AAMI/ISO 18242:2016

    Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
    18.11.2016 - Paper - Englisch - AAMI
    mehr dazu
    212,00 €

  • AAMI/ISO 18242:2016

    Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
    18.11.2016 - PDF - Englisch - AAMI
    mehr dazu
    150,00 €

  • AAMI TIR28:2016 (R2020)

    Product adoption and process equivalency for ethylene oxide sterilization
    18.11.2016 - Paper - Englisch - AAMI
    mehr dazu
    212,00 €

  • AAMI TIR28:2016 (R2020)

    Product adoption and process equivalency for ethylene oxide sterilization
    18.11.2016 - PDF - Englisch - AAMI
    mehr dazu
    150,00 €

  • AAMI/ISO 15676:2016

    Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
    18.11.2016 - PDF - Englisch - AAMI
    mehr dazu
    150,00 €

  • AAMI/ISO 22442-1:2016

    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
    17.11.2016 - Paper - Englisch - AAMI
    mehr dazu
    260,00 €

  • AAMI/ISO 22442-1:2016

    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
    17.11.2016 - PDF - Englisch - AAMI
    mehr dazu
    198,00 €

  • AAMI/ISO 22442-2:2016

    Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
    17.11.2016 - Paper - Englisch - AAMI
    mehr dazu
    212,00 €

  • AAMI/ISO 22442-2:2016

    Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
    17.11.2016 - PDF - Englisch - AAMI
    mehr dazu
    150,00 €

  • AAMI/ISO 15674:2016

    Cardiovascular implants and artificial organs - Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
    16.11.2016 - Paper - Englisch - AAMI
    mehr dazu
    192,00 €

  • AAMI/ISO 15674:2016

    Cardiovascular implants and artificial organs - Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
    16.11.2016 - PDF - Englisch - AAMI
    mehr dazu
    130,00 €

  • AAMI/ISO 18241:2016

    Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
    07.11.2016 - Paper - Englisch - AAMI
    mehr dazu
    248,00 €

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