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  • AAMI TIR45:2023

    Guidance on the use of agile practices in the development of medical device software
    15.03.2023 - PDF - Englisch -
    mehr dazu
    330,00 €

  • AAMI TIR34971:2023

    Application of ISO 14971 to machine learning in artificial intelligence—Guide
    14.03.2023 - PDF - Englisch -
    mehr dazu
    233,00 €

  • AAMI/ISO 15223-1:2022:2023

    Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
    09.01.2023 - PDF - Englisch -
    mehr dazu
    266,00 €

  • AAMI/ISO TI:2022 (R2245)6: 2022

    Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
    27.12.2022 - PDF - Englisch -
    mehr dazu
    189,00 €

  • AAMI SW96:2023:2022

    Standard for medical device security—Security risk management for device manufacturers
    21.12.2022 - PDF - Englisch -
    mehr dazu
    285,00 €

  • 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
    21.12.2022 - PDF - Englisch -
    mehr dazu
    233,00 €

  • AAMI ST98:2022

    Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
    22.08.2022 - PDF - Englisch -
    mehr dazu
    259,00 €

  • 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
    22.08.2022 - PDF - Englisch -
    mehr dazu
    277,00 €

  • 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
    22.08.2022 - PDF - Englisch -
    mehr dazu
    1.168,00 €

  • AAMI ST44 : 2002

    Resistometers used for characterizing the performance of biological and chemical indicators
    10.07.2022 - PDF - Englisch -
    mehr dazu
    86,00 €

  • AAMI/ISO TIR 11137-4:2022

    Sterilization of health care products-Radiation-Part 4: Guidance on process control
    12.06.2022 - PDF - Englisch -
    mehr dazu
    276,00 €

  • AAMI 2800-1-3:2022

    Standard for Interoperable Item Integration Life Cycle (ANSI/AAMI/UL 2800-1-3:2022)
    10.06.2022 - PDF - Englisch -
    mehr dazu
    227,00 €

  • AAMI 2800-1-2:2022

    Standard for Interoperable Item Development Life Cycle (ANSI/AAMI/UL 2800-1-2:2022)
    10.06.2022 - PDF - Englisch -
    mehr dazu
    259,00 €

  • AAMI 2800-1:2022

    Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2022)
    10.06.2022 - PDF - Englisch -
    mehr dazu
    320,00 €

  • 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 -
    mehr dazu
    276,00 €

  • AAMI TIR100: 2021:2022

    End-to-end microbiological quality and sterility assurance
    10.05.2022 - PDF - Englisch -
    mehr dazu
    184,00 €

  • 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 -
    mehr dazu
    259,00 €

  • AAMI TIR104:2022

    Guidance on transferring health care products between radiation sterilization sources
    19.04.2022 - PDF - Englisch -
    mehr dazu
    227,00 €

  • AAMI CR34971:2022

    Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
    01.04.2022 - PDF - Englisch -
    mehr dazu
    227,00 €

  • 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 -
    mehr dazu
    125,00 €

  • 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 -
    mehr dazu
    259,00 €

  • 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 -
    mehr dazu
    268,00 €

  • AAMI TIR58:2021

    Water testing methodologies
    21.12.2021 - PDF - Englisch -
    mehr dazu
    251,00 €

  • AAMI ST91:2021

    Flexible and semi-rigid endoscope processing in health care facilities
    21.12.2021 - PDF - Englisch -
    mehr dazu
    373,00 €

  • AAMI/ISO CN27:2021

    General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
    06.12.2021 - PDF - Englisch -
    mehr dazu
    220,00 €

  • AAMI TIR 101:2021

    Fluid delivery performance testing for infusion pumps
    15.10.2021 - PDF - Englisch -
    mehr dazu
    268,00 €

  • AAMI CR510:2021

    Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
    24.09.2021 - PDF - Englisch -
    mehr dazu
    125,00 €

  • 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 -
    mehr dazu
    302,00 €

  • 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 -
    mehr dazu
    251,00 €

  • AAMI TIR42:2021

    Evaluation of particulate associated with vascular medical devices
    31.03.2021 - PDF - Englisch -
    mehr dazu
    251,00 €

  • AAMI TIR43:2021

    Ultrapure dialysis fluid for hemodialysis and related therapies
    26.02.2021 - PDF - Englisch -
    mehr dazu
    251,00 €

  • AAMI/ISO 14155:2020

    Clinical investigation of medical devices for human subjects - Good clinical practice
    07.12.2020 - PDF - Englisch -
    mehr dazu
    310,00 €

  • 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 -
    mehr dazu
    144,00 €

  • 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 -
    mehr dazu
    144,00 €

  • 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 -
    mehr dazu
    268,00 €

  • AAMI TIR105:2020

    Risk management guidance for combination products
    10.09.2020 - PDF - Englisch -
    mehr dazu
    251,00 €

  • 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 -
    mehr dazu
    220,00 €

  • 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 -
    mehr dazu
    268,00 €

  • 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 -
    mehr dazu
    24,00 €

  • AAMI/ISO 8637-1:2017:2020

    Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
    01.07.2020 - PDF - Englisch -
    mehr dazu
    220,00 €

  • 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 -
    mehr dazu
    179,00 €

  • 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 -
    mehr dazu
    268,00 €

  • AAMI/ISO 8637-3:2018:2020

    Extracorporeal systems for blood purification - Part 3: Plasmafilters
    01.07.2020 - PDF - Englisch -
    mehr dazu
    179,00 €

  • AAMI/ISO 10993-11:2017

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
    27.04.2020 - PDF - Englisch -
    mehr dazu
    220,00 €

  • AAMI/ISO 10993-4:2017

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
    27.04.2020 - PDF - Englisch -
    mehr dazu
    268,00 €

  • 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 -
    mehr dazu
    268,00 €

  • 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 -
    mehr dazu
    251,00 €

  • AAMI/ISO TI (R2041)6:2020

    Medical devices - Post-market surveillance for manufacturers
    16.02.2020 - PDF - Englisch -
    mehr dazu
    260,00 €

  • AAMI/ISO TI (R2497)1:2020

    Medical devices - Guidance on the application of ISO 14971
    02.02.2020 - PDF - Englisch -
    mehr dazu
    310,00 €

  • AAMI RD47:2020

    Reprocessing of hemodialyzers
    23.01.2020 - PDF - Englisch -
    mehr dazu
    268,00 €

  • 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 -
    mehr dazu
    143,00 €

  • AAMI/ISO 80369-1:2018

    Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
    30.12.2019 - PDF - Englisch -
    mehr dazu
    140,00 €

  • 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 -
    mehr dazu
    310,00 €

  • 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 -
    mehr dazu
    251,00 €

  • 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 -
    mehr dazu
    179,00 €

  • 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 -
    mehr dazu
    220,00 €

  • 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 -
    mehr dazu
    179,00 €

  • AAMI CR500:2019

    Basic Introduction to the IEC 60601 Series
    18.12.2019 - PDF - Englisch -
    mehr dazu
    179,00 €

  • AAMI ST72:2019

    Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing, Includes Erratum (2020)
    01.11.2019 - PDF - Englisch -
    mehr dazu
    268,00 €

  • 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 -
    mehr dazu
    268,00 €

  • 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 -
    mehr dazu
    310,00 €

  • AAMI TIR97:2019 (R2023)

    Principles for medical device security - Postmarket risk management for device manufacturers
    27.09.2019 - PDF - Englisch -
    mehr dazu
    285,00 €

  • 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 -
    mehr dazu
    310,00 €

  • 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 -
    mehr dazu
    144,00 €

  • 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 -
    mehr dazu
    179,00 €

  • 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 -
    mehr dazu
    220,00 €

  • AAMI TIR75:2019

    Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
    01.06.2019 - PDF - Englisch -
    mehr dazu
    220,00 €

  • AAMI/ISO 14971:2019

    Medical devices - Application of risk management to medical devices
    01.05.2019 - PDF - Englisch -
    mehr dazu
    268,00 €

  • AAMI EQ93:2019

    Medical equipment management - Vocabulary used in medical equipment programs
    18.04.2019 - PDF - Englisch -
    mehr dazu
    125,00 €

  • AAMI/ISO 81060-2:2019

    Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
    22.03.2019 - PDF - Englisch -
    mehr dazu
    251,00 €

  • 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 -
    mehr dazu
    310,00 €

  • AAMI TIR38:2019

    Medical device safety assurance case report guidance
    25.01.2019 - PDF - Englisch -
    mehr dazu
    268,00 €

  • 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 -
    mehr dazu
    144,00 €

  • 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 -
    mehr dazu
    179,00 €

  • AAMI SW91:2018

    Classification of defects in health software
    02.11.2018 - PDF - Englisch -
    mehr dazu
    268,00 €

  • AAMI TIR68:2018 (R2022)

    Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
    30.09.2018 - PDF - Englisch -
    mehr dazu
    227,00 €

  • 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 -
    mehr dazu
    220,00 €

  • 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
    01.09.2018 - PDF - Englisch -
    mehr dazu
    251,00 €

  • AAMI/ISO TI(R2190)0:2018

    Guidance for uncertainty analysis regarding the application of ISO/TS 10974
    19.07.2018 - PDF - Englisch -
    mehr dazu
    144,00 €

  • AAMI TIR77:2018

    Technical Information Report Sorbent-based regenerative hemodialysis systems
    08.06.2018 - PDF - Englisch -
    mehr dazu
    179,00 €

  • 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 -
    mehr dazu
    333,00 €

  • 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 -
    mehr dazu
    276,00 €

  • AAMI TIR40:2018 (R2022)

    Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
    31.01.2018 - PDF - Englisch -
    mehr dazu
    189,00 €

  • 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 -
    mehr dazu
    190,00 €

  • AAMI TIR16:2017 (R2020)

    Microbiological aspects of ethylene oxide sterilization
    17.11.2017 - PDF - Englisch -
    mehr dazu
    179,00 €

  • AAMI/ISO 13408-2:2018

    Aseptic processing of health care products - Part 2:Sterilizing filtration
    17.11.2017 - PDF - Englisch -
    mehr dazu
    144,00 €

  • 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 -
    mehr dazu
    144,00 €

  • 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 -
    mehr dazu
    268,00 €

  • AAMI TIR72:2017

    Dialysis fluid chemical composition
    08.09.2017 - PDF - Englisch -
    mehr dazu
    144,00 €

  • 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 -
    mehr dazu
    173,00 €

  • 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 -
    mehr dazu
    220,00 €

  • AAMI/ISO TIR80002-2:2017

    Medical device software - Part 2: Validation of software for medical device quality systems
    18.08.2017 - PDF - Englisch, Französisch -
    mehr dazu
    310,00 €

  • AAMI TIR71:2017/ (R2020)

    Guidance for logging of alarm system data
    11.08.2017 - PDF - Englisch -
    mehr dazu
    144,00 €

  • AAMI TIR59:2017

    Integrating human factors into design controls
    04.08.2017 - PDF - Englisch -
    mehr dazu
    220,00 €

  • 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 -
    mehr dazu
    125,00 €

  • 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 -
    mehr dazu
    125,00 €

  • AAMI/ISO 11138-1:2017

    Sterilization of health care products - Biological indicators - Part 1: General requirements
    01.08.2017 - PDF - Englisch -
    mehr dazu
    268,00 €

  • 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 -
    mehr dazu
    125,00 €

  • 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 -
    mehr dazu
    125,00 €

  • 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 -
    mehr dazu
    268,00 €

  • AAMI ST90:2017

    Processing of health care products - Quality management systems for processing in health care facilities
    18.07.2017 - PDF - Englisch -
    mehr dazu
    251,00 €

  • 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
    30.06.2017 - PDF - Englisch -
    mehr dazu
    268,00 €

  • AAMI TIR21:2017 (R2020)

    Systems Used to Forecast Remaining Pacemaker Battery Service Life
    11.06.2017 - PDF - Englisch -
    mehr dazu
    268,00 €

  • AAMI/ISO 25539-1:2017

    Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
    25.05.2017 - PDF - Englisch -
    mehr dazu
    220,00 €

  • AAMI/ISO 14708-3:2017

    Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
    02.03.2017 - PDF - Englisch -
    mehr dazu
    251,00 €

  • ANSI/AAMI/ISO 10993-6:2016

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
    10.01.2017 - PDF - Englisch -
    mehr dazu
    179,00 €

  • AAMI CI86:2017

    Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
    06.01.2017 - PDF - Englisch -
    mehr dazu
    310,00 €

  • AAMI TIR15:2016 (R2020)

    Physical aspects of ethylene oxide sterilization
    18.11.2016 - PDF - Englisch -
    mehr dazu
    179,00 €

  • AAMI TIR28:2016 (R2020)

    Product adoption and process equivalency for ethylene oxide sterilization
    18.11.2016 - PDF - Englisch -
    mehr dazu
    144,00 €

  • AAMI/ISO 15675:2016

    Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
    18.11.2016 - PDF - Englisch -
    mehr dazu
    125,00 €

  • AAMI/ISO 7199:2016

    Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
    18.11.2016 - PDF - Englisch -
    mehr dazu
    144,00 €

  • AAMI/ISO 18242:2016

    Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
    18.11.2016 - PDF - Englisch -
    mehr dazu
    144,00 €

  • 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 -
    mehr dazu
    268,00 €

  • 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 -
    mehr dazu
    144,00 €

  • 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 -
    mehr dazu
    144,00 €

  • AAMI/ISO 22442-1:2016

    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
    17.11.2016 - PDF - Englisch -
    mehr dazu
    190,00 €

  • 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 -
    mehr dazu
    125,00 €

  • AAMI/ISO 18241:2016

    Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
    07.11.2016 - PDF - Englisch -
    mehr dazu
    179,00 €

  • AAMI ST55:2016 (R2023)

    Table-Top Steam Sterilizers
    01.11.2016 - PDF - Englisch -
    mehr dazu
    233,00 €

  • AAMI/ISO TI(R1902)4:2016

    Evaluation of CPB devices relative to their capabilities of reducing the transmition of gaseous microemboli (GME) to a patient during cardiopulmonary bypass
    09.10.2016 - PDF - Englisch -
    mehr dazu
    179,00 €

  • AAMI/IEC TIR80002-3:2016

    Technical Information Report Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
    12.08.2016 - PDF - Englisch, Französisch -
    mehr dazu
    220,00 €

  • 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
    10.08.2016 - PDF - Englisch -
    mehr dazu
    268,00 €

  • AAMI TIR74:2016

    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
    09.08.2016 - PDF - Englisch -
    mehr dazu
    144,00 €

  • AAMI/ISO 80369-6:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
    04.08.2016 - PDF - Englisch -
    mehr dazu
    268,00 €

  • AAMI/ISO 80369-5:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
    04.08.2016 - PDF - Englisch -
    mehr dazu
    220,00 €

  • AAMI TIR57:2016 (R2019) (R2023)

    Principles for medical device security - Risk management
    03.08.2016 - PDF - Englisch -
    mehr dazu
    330,00 €

  • AAMI/ISO 7198:2016

    Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
    02.08.2016 - PDF - Englisch -
    mehr dazu
    268,00 €

  • AAMI/ISO 80369-3:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
    05.06.2016 - PDF - Englisch -
    mehr dazu
    268,00 €

  • AAMI TIR14:2016 (R2020)

    Contract sterilization using ethylene oxide
    05.06.2016 - PDF - Englisch -
    mehr dazu
    144,00 €

  • AAMI TIR35:2016 (R2021)

    Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
    04.06.2016 - PDF - Englisch -
    mehr dazu
    220,00 €

  • AAMI/IEC 62304:2006 & A1:2016

    Medical device software - Software life cycle processes - Consolidated Text
    07.04.2016 - PDF - Englisch -
    mehr dazu
    268,00 €

  • AAMI/IEC 62304:2006/A1:2016

    Medical device software - Software life cycle processes, Amendment 1
    07.04.2016 - PDF - Englisch -
    mehr dazu
    223,00 €

  • AAMI/ISO 13485:2016(R2019)

    Medical devices - Quality management systems - Requirements for regulatory purposes
    25.03.2016 - PDF - Englisch -
    mehr dazu
    268,00 €

  • Checklist for ISO 13485:2016, Medical Devices - Quality Management Systems- Requ

    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
    01.03.2016 - PDF - Englisch -
    mehr dazu
    353,00 €

  • AAMI/IEC TIR60878:2015

    Graphical Symbols for Electrical Equipment in Medical Practice
    03.01.2016 - PDF - Englisch, Französisch -
    mehr dazu
    480,00 €

  • AAMI TIR65:2015

    Sustainability of medical devices--Elements of a responsible product life cycle
    01.01.2016 - PDF - Englisch -
    mehr dazu
    251,00 €

  • AAMI/ISO 12417-1:2015

    Cardiovascular implants and extracorporeal systems - Vascular device-drugcombination products - Part 1: General requirements
    15.11.2015 - PDF - Englisch -
    mehr dazu
    221,00 €

  • SEPT IEC 62304 Checklist:2015

    IEC 62304:2015, Medical Device Software - Software Life Cycle Processes
    20.10.2015 - PDF - Englisch -
    mehr dazu
    353,00 €

  • AAMI TIR48:2015 (R2021)

    Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
    14.08.2015 - PDF - Englisch -
    mehr dazu
    179,00 €

  • AAMI/IEC TIR80001-2-6:2014

    Application of risk management for IT-networks incorporating medical - Application guidance - Part 2-6: Guidance for responsibility agreements
    09.08.2015 - PDF - Englisch -
    mehr dazu
    144,00 €

  • 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
    27.07.2015 - PDF - Englisch -
    mehr dazu
    310,00 €

  • AAMI/ISO 80369-20:2015

    Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
    30.03.2015 - PDF - Englisch -
    mehr dazu
    251,00 €

  • AAMI EQ89:2015 (R2023)

    Guidance for the use of medical equipment maintenance strategies and procedures
    06.02.2015 - PDF - Englisch -
    mehr dazu
    153,00 €

  • AAMI/IEC TIR80001-2-5:2014

    Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
    24.12.2014 - PDF - Englisch -
    mehr dazu
    220,00 €

  • AAMI/IEC TIR80001-2-7:2014

    Application of risk management for IT-networks incorporating medical - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
    24.12.2014 - PDF - Englisch -
    mehr dazu
    310,00 €

  • AAMI TIR55:2014(R2017)

    Human factors engineering for processing medical devices
    23.12.2014 - PDF - Englisch -
    mehr dazu
    179,00 €

  • AAMI TIR63:2014(R2017) (R2023)

    Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
    23.12.2014 - PDF - Englisch -
    mehr dazu
    153,00 €

  • AAMI/ISO TIR37137:2014

    Cardiovascular biological evaluation of medical device - Guidance for absorbable implants
    28.11.2014 - PDF - Englisch -
    mehr dazu
    144,00 €

  • AAMI TIR62:2014(R2019)

    Generating reports for the purpose of submitting defibrillation waveform data for evaluation
    24.10.2014 - PDF - Englisch -
    mehr dazu
    125,00 €

  • AAMI TIR61:2014 (R2019)

    Generating reports for human factors design validation results for external cardiac defibrillators
    24.10.2014 - PDF - Englisch -
    mehr dazu
    144,00 €

  • AAMI TIR60:2014(R2019)

    Common mode rejection in ECG monitoring
    24.10.2014 - PDF - Englisch -
    mehr dazu
    144,00 €

  • AAMI TIR51:2014(R2017)

    Human factors engineering - Guidance for contextual inquiry
    24.10.2014 - PDF - Englisch -
    mehr dazu
    144,00 €

  • 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
    08.10.2014 - PDF - Englisch -
    mehr dazu
    268,00 €

  • AAMI/ISO 11140-1:2014

    Sterilization of health care products - Chemical indicators - Part 1: General requirements
    10.09.2014 - PDF - Englisch -
    mehr dazu
    179,00 €

  • AAMI/ISO 10993-3:2014

    Biological evaluation of medical devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    14.08.2014 - PDF - Englisch -
    mehr dazu
    144,00 €

  • AAMI/ISO TI(R1677)5:2014

    Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
    27.07.2014 - PDF - Englisch -
    mehr dazu
    310,00 €

  • AAMI/ISO 5841-2:2014

    Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
    21.07.2014 - PDF - Englisch -
    mehr dazu
    168,00 €

  • AAMI/ISO TI(R1766)5-3:2014/(R)2016

    Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical product to a product family and processing category for steam sterilization
    18.05.2014 - PDF - Englisch -
    mehr dazu
    268,00 €

  • AAMI/ISO TI(R1713)7:2014

    Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
    04.05.2014 - PDF - Englisch -
    mehr dazu
    173,00 €

  • AAMI TIR52:2014(R2017) (R2023)

    Environmental Monitoring For Terminally Sterilized Healthcare Products
    10.03.2014 - PDF - Englisch -
    mehr dazu
    134,00 €

  • AAMI TIR50:2014(R2017)

    Post-market surveillance of use error management
    10.03.2014 - PDF - Englisch -
    mehr dazu
    214,00 €

  • AAMI TIR37:2013

    Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products.
    30.12.2013 - PDF - Englisch -
    mehr dazu
    144,00 €

  • AAMI/ISO 11137-1:2006(R2015) & A1:2003 & A2:2019 (Consolidated Text)

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices, Includes A1:2013 & A2:2019
    30.12.2013 - PDF - Englisch -
    mehr dazu
    268,00 €

  • AAMI TIR56:2013(R2016) (R2020)

    Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
    27.12.2013 - PDF - Englisch -
    mehr dazu
    179,00 €

  • AAMI ST79:2010/A4:2013 (R2014)

    Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Amendment 4
    14.10.2013 - PDF - Englisch -
    mehr dazu
    102,00 €

  • AAMI/ISO TI(R1300)4:2013/(R)2016

    Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmaxSD
    04.10.2013 - PDF - Englisch -
    mehr dazu
    268,00 €

  • AAMI AT6:2013

    Autologous transfusion devices
    27.08.2013 - PDF - Englisch -
    mehr dazu
    140,00 €

  • AAMI/ISO TI(R1921)8-1:2011/A1:2013

    Medical devices - Hierarchal coding structure for adverse events - Part 1: Event type codes, Amendment 1
    01.08.2013 - PDF - Englisch -
    mehr dazu
    71,00 €

  • AAMI/ISO 5841-3:2013 (R2018)

    Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
    29.07.2013 - PDF - Englisch -
    mehr dazu
    132,00 €

  • AAMI/ISO 11137-2:2013(R2019)

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
    10.07.2013 - PDF - Englisch -
    mehr dazu
    268,00 €

  • 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
    30.04.2013 - PDF - Englisch -
    mehr dazu
    179,00 €

  • AAMI ST8:2013 (R2018)

    Hospital steam sterilizers
    25.04.2013 - PDF - Englisch -
    mehr dazu
    220,00 €

  • AAMI/ISO 13408-1:2008(R2011)/A1:2013

    Aseptic processing of health care products--Part 1: General requirements, Amendment 1
    27.03.2013 - PDF - Englisch -
    mehr dazu
    71,00 €

  • AAMI TIR49:2013 (R2020)

    Design of training and instructional materials for medical devices used in non-clinical environments
    19.03.2013 - PDF - Englisch -
    mehr dazu
    251,00 €

  • AAMI EQ56:2013

    Recommended practices for a medical equipment management program
    13.03.2013 - PDF - Englisch -
    mehr dazu
    220,00 €

  • AAMI/ISO 13408-6:2005/A1:2013

    Aseptic processing of health care products - Part 6: Isolator systems, Amendment 1
    11.03.2013 - PDF - Englisch -
    mehr dazu
    73,00 €

  • AAMI ST77:2013 (R2018)

    Containment devices for reusable medical device sterilization
    01.02.2013 - PDF - Englisch -
    mehr dazu
    179,00 €

  • AAMI TIR29:2012(R2017)

    Guide for process characterization and control in radiation sterilization of medical devices
    31.12.2012 - PDF - Englisch -
    mehr dazu
    251,00 €

  • AAMI EC57:2012 (R2020)

    Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms
    18.12.2012 - PDF - Englisch -
    mehr dazu
    220,00 €

  • AAMI/ISO TI(R1921)8-2:2012

    Medical devices -Hierarchical coding structure for adverse events - Part 2: Evaluation codes
    10.12.2012 - PDF - Englisch -
    mehr dazu
    132,00 €

  • AAMI/ISO 25539-2:2012

    Cardiovascular implants --Endovascular devices --Part 2: Vascular stents
    03.12.2012 - PDF - Englisch -
    mehr dazu
    310,00 €

  • ANSI/AAMI ST15883-3:2012/(R)2015 (R2023)

    Washer-disinfectors -Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006, MOD)
    03.12.2012 - PDF - Englisch -
    mehr dazu
    153,00 €

  • ANSI/AAMI ST15883-2:2013/(R)2015 (R2023)

    Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006, MOD)
    03.12.2012 - PDF - Englisch -
    mehr dazu
    153,00 €

  • AAMI BF7:2012

    Blood transfusion micro-filters
    30.11.2012 - PDF - Englisch -
    mehr dazu
    140,00 €

  • AAMI BF64:2012

    Leukocyte reduction filters
    29.11.2012 - PDF - Englisch -
    mehr dazu
    140,00 €

  • AAMI TIR44:2012

    Non-invasive blood pressure motion artifact - Testing and evaluation of NIBP device performance in the presence of motion artifact
    16.11.2012 - PDF - Englisch -
    mehr dazu
    179,00 €

  • AAMI/ISO 11658:2012

    Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
    20.10.2012 - PDF - Englisch -
    mehr dazu
    125,00 €

  • AAMI/ISO 13408-7:2012(R2018)

    Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products
    27.09.2012 - PDF - Englisch -
    mehr dazu
    179,00 €

  • AAMI/IEC TIR80001-2-3:2012

    Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
    02.09.2012 - PDF - Englisch -
    mehr dazu
    251,00 €

  • 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
    02.09.2012 - PDF - Englisch -
    mehr dazu
    268,00 €

  • AAMI ST79:2010/A3:2012 (R2014)

    Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Amendment 3
    23.08.2012 - PDF - Englisch -
    mehr dazu
    102,00 €

  • AAMI TIR45:2012(R2018)

    Guidance on the use of agile practices in the development of medical device software
    20.08.2012 - PDF - Englisch -
    mehr dazu
    268,00 €

  • 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
    20.08.2012 - PDF - Englisch -
    mehr dazu
    268,00 €

  • AAMI/ISO TI(R2381)0:2012/(R)2015

    Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup
    06.08.2012 - PDF - Englisch -
    mehr dazu
    220,00 €

  • AAMI/IEC 60601-2-47:2012 (R2016)

    Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
    01.08.2012 - PDF - Englisch -
    mehr dazu
    268,00 €

  • ANSI/AAMI/ISO 10993-12:2012

    Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
    26.07.2012 - PDF - Englisch -
    mehr dazu
    179,00 €

  • AAMI/ISO 25539-3:2011(R2015)

    Cardiovascular implants - Endovascular devices - Part 3: Vena Cava Filters
    05.06.2012 - PDF - Englisch -
    mehr dazu
    310,00 €

  • AAMI SW87:2012

    Application of quality management system concepts to medical device data systems
    23.05.2012 - PDF - Englisch -
    mehr dazu
    158,00 €

  • AAMI/ISO 13022:2012

    Medical products containing viable human cells -- Application of risk management and requirements for processing practices
    03.05.2012 - PDF - Englisch -
    mehr dazu
    268,00 €

  • AAMI/ISO 27185:2012(R2017)

    Active implantable medical devices - Symbols to be used with cardiac device labels, labeling and information to be supplied by the manufacturer
    13.01.2012 - PDF - Englisch -
    mehr dazu
    268,00 €

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