AAMI

 

 

AAMI (Association for the Advancement of Medical Instrumentation) is a non-profit organization that accredits medical device manufacturers and suppliers. AAMI's accreditation program evaluates compliance with quality and performance standards for medical devices. It also provides guidelines and recommendations for the design, testing, and labeling of medical devices.

 

By using AAMI-accredited devices, healthcare providers can ensure that their patients receive safe and effective care.

 

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  • ANSI/AAMI/ISO 10993-13-2010/(R)2019:2023

    Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices
    01.01.2023 - PDF - Englisch - AAMI
    mehr dazu
    119,00 €

  • ANSI/AAMI/ISO 10993-3:2023

    Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
    01.01.2023 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI SW96:2023

    Standard for medical device security—Security risk management for device manufacturers
    01.01.2023 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • AAMI TIR34971:2023

    Application of ISO 14971 to machine learning in artificial intelligence—Guide
    01.01.2023 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • AAMI TIR45:2023

    Guidance on the use of AGILE practices in the development of medical device software
    01.01.2023 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • AAMI TIR45:2023 Redline

    Guidance on the use of AGILE practices in the development of medical device software
    01.01.2023 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • ANSI/AAMI/ISO 11138-8:2023

    Sterilization of health care products—Biological indicators—Part 8: Method for validation of a reduced incubation item for a biological indicator
    01.01.2023 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • AAMI/ISO TIR16775:2023

    Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2
    01.01.2023 - PDF - Englisch - AAMI
    mehr dazu
    352,00 €

  • ANSI/AAMI ST108:2023

    Water for the processing of medical devices
    01.01.2023 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • AAMI/ISO TIR21387:2023

    Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
    01.01.2023 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • ANSI/AAMI HIT1000-1:2022

    Safety and effectiveness of health IT software and systems—Part 1: Fundamental concepts, principles, and requirements
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • AAMI TIR104:2022

    Guidance on transferring health care products between radiation sterilization sources
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • ANSI/AAMI 2700-2-1:2022

    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
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • ANSI/AAMI/UL 2800-1-1:2022

    Standard for Risk Concerns for Interoperable Medical Products
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/UL 2800-1-2:2022

    Standard for Interoperable Item Development Life Cycle
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • ANSI/AAMI/UL 2800-1-3:2022

    Standard for Interoperable Item Integration Life Cycle
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • ANSI/AAMI/UL 2800-1:2022

    Standard for Medical Device Interoperability
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • ANSI/AAMI/ISO 18472:2022

    Sterilization of health care products—Biological and chemical indicators—Test equipment
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • ANSI/AAMI/ISO 5840-1:2022

    Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • ANSI/AAMI/ISO 5840-2:2022

    Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 5840-3:2022

    Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 15223-1:2022

    Medical devices—Symbols to be used with information to be supplied by the manufacturer— Part 1: General requirements
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • AAMI/ISO TIR22456:2022

    Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • ANSI/AAMI PB70:2022 Redline

    Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 17664-1:2022

    Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • ANSI/AAMI/ISO 17664-2:2022

    Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • ANSI/AAMI ST98:2022

    Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • AAMI/ISO TIR11137-4:2022

    Sterilization of health care products—Radiation—Part 4: Guidance on process control
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI PB70:2022

    Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
    01.01.2022 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • AAMI CR510:2021

    Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
    01.01.2021 - PDF - Englisch - AAMI
    mehr dazu
    119,00 €

  • AAMI TIR101:2021

    Fluid delivery performance testing for infusion pumps
    01.01.2021 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI CN27:2021

    General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
    01.01.2021 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • AAMI TIR58:2021

    Water testing methodologies
    01.01.2021 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • ANSI/AAMI ST91:2021

    Flexible and semi-rigid endoscope processing in health care facilities
    01.01.2021 - PDF - Englisch - AAMI
    mehr dazu
    341,00 €

  • AAMI TIR42:2021

    Evaluation of particulate associated with vascular medical devices
    01.01.2021 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • ANSI/AAMI PC76:2021

    Active implantable medical devices— Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
    01.01.2021 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • AAMI TIR43:2021

    Ultrapure dialysis fluid for hemodialysis and related therapies
    01.01.2021 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • 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
    01.01.2021 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • AAMI TIR100:2021

    End-to-end microbiological quality and sterility assurance
    01.01.2021 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • AAMI/ISO TIR20416:2020

    Medical devices—Post-market surveillance for manufacturers
    01.01.2020 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • AAMI/ISO TIR24971:2020

    Medical devices—Guidance on the application of ISO 14971
    01.01.2020 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • ANSI/AAMI RD47:2020

    Reprocessing of hemodialyzers
    01.01.2020 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI MP80601-2-49:2020 (IEC 80601-2-49:2020, MOD)

    Medical electrical equipment—Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
    01.01.2020 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • AAMI HIT1000-4(PS):2020

    Safety and effectiveness of health IT software and systems—Part 4: Application of human factors engineering
    01.01.2020 - PDF - Englisch - AAMI
    mehr dazu
    20,00 €

  • AAMI TIR105:2020

    Risk management guidance for combination products
    01.01.2020 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • ANSI/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
    01.01.2020 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/IEC 80601-2-78:2020

    Medical electrical equipment—Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
    01.01.2020 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • AAMI TIR12:2020

    Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
    01.01.2020 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 14155:2020

    Clinical investigation of medical devices for human subjects—Good clinical practice
    01.01.2020 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • AAMI TIR97:2019/(R)2023

    Principles for medical device security—Postmarket risk management for device manufacturers
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • AAMI HIT1000-3(PS):2019

    Safety and effectiveness of health IT software and systems—Part 3: Application of risk management
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    20,00 €

  • AAMI TIR102:2019

    U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • AAMI TIR38:2019

    Medical device safety assurance case guidance
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • AAMI TIR75:2019

    Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • ANSI/AAMI EQ93:2019

    Medical equipment management—Vocabulary used in medical equipment programs
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    119,00 €

  • 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
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • ANSI/AAMI ST67:2019

    Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled —sterile—
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI ST72:2019

    Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 11138-7:2019

    Sterilization of health care products—Biological indicators—Part 7: Guidance for the selection, use and interpretation of results
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 14117:2019

    Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • ANSI/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
    168,00 €

  • ANSI/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
    136,00 €

  • ANSI/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
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • ANSI/AAMI/ISO 14971:2019

    Medical devices—Application of risk management to medical devices
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 23500-1:2019

    Preparation and quality management of fluids for haemodialysis and related therapies—Part 1: General requirements
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • ANSI/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
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • ANSI/AAMI/ISO 23500-3:2019

    Preparation and quality management of fluids for haemodialysis and related therapies—Part 3: Water for haemodialysis and related therapies
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • ANSI/AAMI/ISO 23500-4:2019

    Preparation and quality management of fluids for haemodialysis and related therapies—Part 4: Concentrates for haemodialysis and related therapies
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • ANSI/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
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • ANSI/AAMI/ISO 81060-2:2019

    Non-invasive sphygmomanometers—Clinical investigation of intermittent automated measurement type
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • AAMI CR500:2019

    Basic Introduction to the IEC 60601 Series
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • ANSI/AAMI/ISO 10993-15:2019

    Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys
    01.01.2019 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • AAMI TIR40:2018/(R)2022

    Sterilization of health care products—Radiation—Guidance on dose setting utilizing a Modified Method 2
    01.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • AAMI TIR77:2018

    Sorbent-based regenerative hemodialysis systems
    01.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • AAMI/ISO TIR10974:2018

    Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
    01.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    314,00 €

  • AAMI/ISO TIR21900:2018

    Guidance for uncertainty analysis regarding the application of ISO/TS 10974
    01.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI SW91:2018

    Classification of defects in health software
    01.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 10993-1:2018

    Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
    01.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 11737-1:2018

    Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products
    01.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 13408-2:2018

    Aseptic processing of health care products—Part 2: Sterilizing filtration
    01.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI/ISO 80369-1:2018

    Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements
    01.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI/IEC 80601-2-30:2018

    Medical electrical equipment—Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
    01.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 8637-3:2018

    Extracorporeal systems for blood purification—Part 3: Plasmafilters
    01.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • ANSI/AAMI/ISO 8637-2:2018

    Extracorporeal systems for blood purification— Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
    01.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • ANSI/AAMI/IEC 60601-2-16:2018

    Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
    01.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/IEC 60601-2-39:2018

    Medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
    01.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • AAMI TIR67:2018/(R)2022

    Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
    01.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • AAMI TIR68:2018/(R)2022

    Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
    01.01.2018 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • AAMI TIR21:2017/(R)2020

    Systems used to forecast remaining pacemaker battery service life
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • AAMI TIR69:2017/(R)2020

    Risk management of radio-frequency wireless coexistence for medical devices and systems
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • AAMI TIR72:2017

    Dialysis fluid chemical composition
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI CI86:2017

    Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • AAMI/ISO TIR15499:2017

    Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • AAMI/ISO TIR80002-2:2017

    Medical device software—Part 2: Validation of software for medical device quality systems
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • ANSI/AAMI ST90:2017

    Processing of health care products—Quality management systems for processing in health care facilities
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • ANSI/AAMI/ISO 10993-11:2017/(R)2023

    Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • ANSI/AAMI/IEC 60601-2-2:2017

    Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 10993-4:2017

    Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 11137-3:2017/(R)2023

    Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine control
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI/ISO 11138-1:2017

    Sterilization of health care products—Biological indicators—Part 1: General requirements
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 11138-2:2017

    Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    119,00 €

  • ANSI/AAMI/ISO 11138-3:2017

    Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    119,00 €

  • ANSI/AAMI/ISO 11138-4:2017

    Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    119,00 €

  • ANSI/AAMI/ISO 11138-5:2017

    Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    119,00 €

  • ANSI/AAMI/ISO 14708-3:2017

    Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulators
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • ANSI/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
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 25539-1:2017

    Cardiovascular implants— Endovascular devices—Part 1: Endovascular prostheses
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • AAMI TIR59:2017

    Integrating human factors into design controls
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • AAMI TIR66:2017/(R)2020

    Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • AAMI TIR71:2017/(R)2020

    Guidance for logging of alarm system data
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI/ISO 8637-1:2017

    Extracorporeal systems for blood purification—Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • AAMI TIR16:2017/(R)2020

    Microbiological aspects of ethylene oxide sterilization
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • ANSI/AAMI/ISO 10993-16:2017/(R)2022

    Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI ST79:2017/(R)2022 w/ AMDs A1:2020, A2:2020, A3:2020, A4:2020

    Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    424,00 €

  • AAMI TIR17:2017/(R)2020

    Compatibility of materials subject to sterilization
    01.01.2017 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • AAMI TIR35:2016/(R)2021

    Sterilization of health care products—Radiation sterilization—Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • AAMI TIR57:2016/(R)2023

    Principles for medical device security—Risk management
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • 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
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • AAMI/IEC TIR80002-3:2016

    Medical Device Software—Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • ANSI/AAMI ST55:2016/(R)2023

    Table-top steam sterilizers
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • ANSI/AAMI/ISO 10993-6:2016

    Biological evaluation of medical devices—Part 6: Tests for local effects after implantation
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • ANSI/AAMI/ISO 13485:2016/(R)2019

    Medical devices—Quality management systems—Requirements for regulatory purposes
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 15674:2016

    Cardiovascular implants and artificial organs—Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    119,00 €

  • ANSI/AAMI/ISO 15675:2016

    Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial blood line filters
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    119,00 €

  • ANSI/AAMI/ISO 15676:2016

    Cardiovascular implants and artificial organs—Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI/ISO 16142-1:2016

    Medical devices—Recognized essential principles of safety and performance of medical devices—Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 18241:2016

    Cardiovascular implants and extracorporeal systems—Cardiopulmonary bypass systems—Venous bubble traps
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • ANSI/AAMI/ISO 18242:2016

    Cardiovascular implants and extracorporeal systems—Centrifugal blood pumps
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI/ISO 22442-1:2016

    Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • ANSI/AAMI/ISO 22442-2:2016

    Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and handling
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI/ISO 80369-3:2016

    Small-bore connectors for liquids and gases in healthcare applications—Part 3: connectors for enteral applications
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 80369-3:2016/A1:2019

    Small-bore connectors for liquids and gases in healthcare applications—Part 3: Connectors for enteral applications—Amendment 1
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI/ISO 80369-5:2016

    Small-bore connectors for liquids and gases in healthcare applications—Part 5: Connectors for limb cuff inflation applications
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • ANSI/AAMI/ISO 80369-6:2016

    Small-bore connectors for liquids and gases in healthcare applications—Part 6: Connectors for neuraxial applications
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 80369-7:2016

    Small-bore connectors for liquids and gases in healthcare applications—Part 7: Connectors for intravascular or hypodermic applications
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO TIR19024:2016

    Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • ANSI/AAMI/ISO 7198:2016

    Cardiovascular implants—Tubular vascular prostheses
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 7199:2016

    Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators)
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • AAMI/IEC TIR62366-2:2016

    Medical devices—Part 2: Guidance on the application of usability engineering to medical devices
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • ANSI/AAMI/IEC 60601-1-12:2016

    Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment & medical electrical systems intended for use in emergency medical services environ.
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • AAMI TIR14:2016/(R)2020

    Contract sterilization using ethylene oxide
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • AAMI TIR28:2016/(R)2020

    Product adoption and process equivalence for ethylene oxide sterilization
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • AAMI TIR15:2016/(R)2020

    Physical aspects of ethylene oxide sterilization
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • AAMI TIR74:2016/(R)2021

    Change summary for ISO 11135:2014, Sterilization of health care products—Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI/IEC 60601-1-12:2016/A1:2021

    Medical electrical equipment—Part 1-12: General requirements—Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services environment—Amendment 1
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    119,00 €

  • ANSI/AAMI/IEC 60601-1-12:2016 & A1:2021 Redline

    Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance— Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services envi
    01.01.2016 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • AAMI TIR65:2015/(R)2022

    Sustainability of medical devices—Elements of a responsible product life cycle
    01.01.2015 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • AAMI/IEC TIR60878:2015

    Graphic symbols for electrical equipment in medical practice
    01.01.2015 - PDF - Englisch - AAMI
    mehr dazu
    452,00 €

  • ANSI/AAMI EQ89:2015/(R)2023

    Guidance for the use of medical equipment maintenance strategies and procedures
    01.01.2015 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI/ISO 80369-20:2015

    Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
    01.01.2015 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • ANSI/AAMI/IEC TIR62354:2015

    General testing procedures for medical electrical equipment
    01.01.2015 - PDF - Englisch - AAMI
    mehr dazu
    476,00 €

  • ANSI/AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD)

    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.
    01.01.2015 - PDF - Englisch - AAMI
    mehr dazu
    352,00 €

  • ANSI/AAMI/IEC 62366-1:2015/(R)2021+AMD1:2020 (Consolidated Text)

    Medical devices—Part 1: Application of usability engineering to medical devices + Amendment 1
    01.01.2015 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • AAMI TIR48:2015/(R)2021

    Quality Management System (QMS) Recommendations on the Application of the U.S. FDA—s CGMP Final Rule on Combination Products
    01.01.2015 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

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

    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, Amendment 1
    01.01.2015 - PDF - Englisch - AAMI
    mehr dazu
    119,00 €

  • ANSI/AAMI HA60601-1-11:2015 & A1:2021 Redline

    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
    01.01.2015 - PDF - Englisch - AAMI
    mehr dazu
    352,00 €

  • AAMI TIR62:2014/(R)2019

    Generating reports for the purpose of submitting defibrillation waveform data for evaluation
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    119,00 €

  • AAMI TIR52:2014/(R)2022

    Environmental monitoring for terminally sterilized healthcare products
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    119,00 €

  • AAMI TIR55:2014/(R)2017

    Human factors engineering for processing medical devices
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • AAMI/IEC TIR80001-2-5:2014

    Application of risk management for IT-networks incorporating medical devices—Part 2-5: Application guidance—Guidance for distributed alarm systems
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • AAMI TIR60:2014/(R)2019

    Common mode rejection in ECG monitoring
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • AAMI TIR61:2014/(R)2019

    Generating reports for human factors design validation results for external cardiac defibrillator
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • AAMI/IEC TIR80001-2-7:2014

    Application of risk management for IT-networks incorporating medical devices—Part 2-7: Application guidance—Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • AAMI/ISO TIR17665-3:2014/(R)2016

    Sterilization of health care products—Moist Heat—Guidance on the designation of a medical product to a product family and processing category for steam sterilization
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/IEC 80601-2-58:2014

    Medical electrical equipment—Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • ANSI/AAMI/IEC 80601-2-58:2014/A1:2016

    Amendment 1 to Medical Electrical Equipment Part 2-58
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI/ISO 11135:2014

    Sterilization of health care products—Ethylene oxide—Requirements for development, validation and routine control of a sterilization process for medical devices
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • ANSI/AAMI/ISO 11135:2014/A1:2018

    Sterilization of health-care products— Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices—Amendment 1: Revision of Annex E, Single batch release
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI/ISO 11140-1:2014

    Sterilization of health care products—Chemical indicators—Part 1: General requirements
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • ANSI/AAMI/ISO 14708-1:2014

    Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO TIR37137:2014

    Cardiovascular biological evaluation of medical devices—Guidance for absorbable implants
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • AAMI TIR50:2014/(R)2017

    Post-market surveillance of use error management
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • AAMI TIR51:2014/(R)2017

    Human factors engineering—Guidance for contextual inquiry
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI/IEC 60601-1-2:2014

    Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    352,00 €

  • AAMI/ISO TIR80001-2-6:2014

    Application of risk management for IT-networks incorporating medical—Application guidance—Part 2-6: Guidance for responsibility agreements
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • AAMI TIR63:2014/(R)2023

    Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

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

    Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests, Amendment 1
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

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

    Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests Consolidated Text, Redline Version
    01.01.2014 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • ANSI/AAMI/ISO TIR13004:2013/(R)2016

    Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmaxSD
    01.01.2013 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI NS4:2013/(R)2017

    Transcutaneous electrical nerve stimulators
    01.01.2013 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI ST15883-2:2013/(R)2023 (ISO 15883-2:2006 MOD)

    Washer-disinfectors—Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
    01.01.2013 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI ST58:2013/(R)2018

    Chemical sterilization and high-level disinfection in health care facilities
    01.01.2013 - PDF - Englisch - AAMI
    mehr dazu
    293,00 €

  • ANSI/AAMI ST77:2013/(R)2018

    Containment devices for reusable medical device sterilization
    01.01.2013 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • ANSI/AAMI/ISO 11137-2:2013/(R)2019

    Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose
    01.01.2013 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI ST8:2013/(R)2018

    Hospital steam sterilizers
    01.01.2013 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • AAMI TIR49:2013/(R)2020

    Design of training and instructional materials for medical devices used in non-clinical environments
    01.01.2013 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • ANSI/AAMI EQ56:2013

    Recommended practice for a medical equipment management program
    01.01.2013 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • AAMI TIR56:2013/(R)2020

    Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
    01.01.2013 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • ANSI/AAMI EC53:2013/(R)2020

    ECG trunk cables and patient leadwires
    01.01.2013 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • AAMI TIR44:2012

    Non-invasive blood pressure motion artifact—Testing and evaluation of NIBP device performance in the presence of motion artifact
    01.01.2012 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • AAMI/IEC TIR80001-2-3:2012

    Application of risk management for IT-networks incorporating medical devices—Part 2-3: Guidance for wireless networks
    01.01.2012 - PDF - Englisch - AAMI
    mehr dazu
    237,00 €

  • AAMI/IEC TIR80001-2-4:2012

    Application of risk management for IT-networks incorporating medical devices—Part 2-4: General implementation guidance for healthcare delivery organizations.
    01.01.2012 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • AAMI/ISO TIR23810:2012/(R)2015

    Cardiovascular implants and artificial organs—Checklist for preoperative extracorporeal circulation equipment setup
    01.01.2012 - PDF - Englisch - AAMI
    mehr dazu
    207,00 €

  • ANSI/AAMI PB70:2012 Red-Line

    Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
    01.01.2012 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI ST15883-3:2012/(R)2023

    Washer-disinfectors—Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
    01.01.2012 - PDF - Englisch - AAMI
    mehr dazu
    136,00 €

  • ANSI/AAMI/ISO 10993-12:2012

    Biological evaluation of medical devices—Part 12: Sample preparation and reference materials
    01.01.2012 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

  • ANSI/AAMI/IEC 60601-2-47:2012/(R)2016

    Medical electrical equipment—Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
    01.01.2012 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/IEC TIR80001-2-1:2012

    Application of risk management for IT-networks incorporating medical devices—Part 2-1: Step by step risk management of medical IT-networks, Practical applications and examples.
    01.01.2012 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/IEC TIR80001-2-2:2012

    Application of risk management for IT-networks incorporating medical devices—Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
    01.01.2012 - PDF - Englisch - AAMI
    mehr dazu
    253,00 €

  • ANSI/AAMI/ISO 13408-7:2012/(R)2018

    Aseptic processing of health care products—Part 7: Alternative processes for medical devices and combination products
    01.01.2012 - PDF - Englisch - AAMI
    mehr dazu
    168,00 €

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