AAMI
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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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AAMI CR515:2025
Cybersecurity considerations unique to machine learning–enabled medical devices
01.01.2025 - PDF - Englisch -
mehr dazu170,00 € -
AAMI TIR109:2025
External transport of reusable medical devices for processing
01.01.2025 - PDF - Englisch -
mehr dazu234,00 € -
AAMI TIR48:2024
Quality Management System (QMS) guidance on compliance with FDA's Final Rule on combination products
01.01.2024 - PDF - Englisch -
mehr dazu267,00 € -
153,00 € -
ANSI/AAMI ST58:2024
Chemical sterilization and high-level disinfection in health care facilities
01.01.2024 - PDF - Englisch -
mehr dazu396,00 € -
267,00 € -
ANSI/AAMI/IEC 80601-2-58:2024
Medical electrical equipment—Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
01.01.2024 - PDF - Englisch -
mehr dazu240,00 € -
AAMI TIR99:2024
Processing of dilators, transesophageal and ultrasound probes in health care facilities
01.01.2024 - PDF - Englisch -
mehr dazu285,00 € -
330,00 € -
AAMI TIR106:2024
Microbiological methods—Understanding and use of product bioburden data
01.01.2024 - PDF - Englisch -
mehr dazu234,00 € -
AAMI CR513:2024
Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing
01.01.2024 - PDF - Englisch -
mehr dazu153,00 € -
ANSI/AAMI EQ103:2024
Alternate equipment management (AEM) program in healthcare delivery organizations (HDOs)
01.01.2024 - PDF - Englisch -
mehr dazu234,00 € -
ANSI/AAMI/ISO 11140-6:2024
Sterilization of health care products—Chemical indicators—Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
01.01.2024 - PDF - Englisch -
mehr dazu285,00 € -
ANSI/AAMI ST24:2024
General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
01.01.2024 - PDF - Englisch -
mehr dazu234,00 € -
330,00 € -
ANSI/AAMI/ISO 13408-1:2023
Aseptic processing of health care products—Part 1: General requirements
01.01.2023 - PDF - Englisch -
mehr dazu330,00 € -
ANSI/AAMI SW96:2023
Standard for medical device security—Security risk management for device manufacturers
01.01.2023 - PDF - Englisch -
mehr dazu285,00 € -
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 -
mehr dazu153,00 € -
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 -
mehr dazu134,00 € -
AAMI TIR45:2023
Guidance on the use of AGILE practices in the development of medical device software
01.01.2023 - PDF - Englisch -
mehr dazu330,00 € -
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 -
mehr dazu189,00 € -
AAMI TIR45:2023 Redline
Guidance on the use of AGILE practices in the development of medical device software
01.01.2023 - PDF - Englisch -
mehr dazu330,00 € -
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 -
mehr dazu396,00 € -
285,00 €
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AAMI TIR34971:2023
Application of ISO 14971 to machine learning in artificial intelligence—Guide
01.01.2023 - PDF - Englisch -
mehr dazu234,00 € -
ANSI/AAMI/UL 2800-1-1:2022
Standard for Risk Concerns for Interoperable Medical Products
01.01.2022 - PDF - Englisch -
mehr dazu285,00 € -
ANSI/AAMI/ISO 5840-1:2022
Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements
01.01.2022 - PDF - Englisch -
mehr dazu330,00 € -
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 -
mehr dazu234,00 € -
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 -
mehr dazu267,00 € -
330,00 € -
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 -
mehr dazu267,00 € -
AAMI/ISO TIR11137-4:2022/(R)2023
Sterilization of health care products—Radiation—Part 4: Guidance on process control
01.01.2022 - PDF - Englisch -
mehr dazu285,00 € -
267,00 € -
ANSI/AAMI/ISO 5840-2:2022
Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes
01.01.2022 - PDF - Englisch -
mehr dazu285,00 € -
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 -
mehr dazu285,00 € -
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 -
mehr dazu267,00 € -
ANSI/AAMI/ISO 13004:2022
Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD
01.01.2022 - PDF - Englisch -
mehr dazu285,00 € -
ANSI/AAMI/ISO 18472:2022
Sterilization of health care products—Biological and chemical indicators—Test equipment
01.01.2022 - PDF - Englisch -
mehr dazu267,00 € -
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 -
mehr dazu189,00 € -
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 -
mehr dazu234,00 € -
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 -
mehr dazu285,00 € -
234,00 € -
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 -
mehr dazu285,00 € -
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 -
mehr dazu267,00 € -
AAMI TIR104:2022
Guidance on transferring health care products between radiation sterilization sources
01.01.2022 - PDF - Englisch -
mehr dazu234,00 € -
285,00 € -
ANSI/AAMI/ISO 20417:2021
Medical devices—Information to be supplied by the manufacturer
01.01.2021 - PDF - Englisch -
mehr dazu330,00 € -
AAMI TIR42:2021
Evaluation of particulate associated with vascular medical devices
01.01.2021 - PDF - Englisch -
mehr dazu267,00 € -
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 -
mehr dazu267,00 € -
267,00 € -
ANSI/AAMI ST91:2021
Flexible and semi-rigid endoscope processing in health care facilities
01.01.2021 - PDF - Englisch -
mehr dazu385,00 € -
ANSI/AAMI CN27:2021
General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
01.01.2021 - PDF - Englisch -
mehr dazu234,00 € -
189,00 € -
AAMI CR510:2021
Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
01.01.2021 - PDF - Englisch -
mehr dazu134,00 € -
AAMI TIR43:2021/(R)2025
Ultrapure dialysis fluid for hemodialysis and related therapies
01.01.2021 - PDF - Englisch -
mehr dazu267,00 € -
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 -
mehr dazu330,00 € -
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 -
mehr dazu285,00 € -
AAMI/ISO TIR10993-19:2020
Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
01.01.2020 - PDF - Englisch -
mehr dazu189,00 € -
ANSI/AAMI/ISO 14155:2020
Clinical investigation of medical devices for human subjects—Good clinical practice
01.01.2020 - PDF - Englisch -
mehr dazu330,00 € -
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 -
mehr dazu285,00 € -
ANSI/AAMI/ISO 10993-16:2020/(R)2022
Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
01.01.2020 - PDF - Englisch -
mehr dazu153,00 € -
330,00 € -
267,00 € -
267,00 € -
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 -
mehr dazu267,00 € -
AAMI TIR12:2020/(R)2023
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
01.01.2020 - PDF - Englisch -
mehr dazu285,00 € -
285,00 € -
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 -
mehr dazu23,00 € -
ANSI/AAMI EQ93:2019/(R)2025
Medical equipment management—Vocabulary used in medical equipment programs
01.01.2019 - PDF - Englisch -
mehr dazu134,00 € -
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 -
mehr dazu189,00 € -
ANSI/AAMI ST72:2019
Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing
01.01.2019 - PDF - Englisch -
mehr dazu285,00 € -
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 -
mehr dazu285,00 € -
189,00 € -
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 -
mehr dazu153,00 € -
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 -
mehr dazu267,00 € -
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 -
mehr dazu189,00 € -
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 -
mehr dazu153,00 € -
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 -
mehr dazu23,00 € -
AAMI/ISO/IEC Guide 63:2019
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
01.01.2019 - PDF - Englisch -
mehr dazu227,00 € -
285,00 € -
ANSI/AAMI/ISO 11607-1:2019/A1:2023
Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems Amendment 1: Application of risk management
01.01.2019 - PDF - Englisch -
mehr dazu189,00 € -
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 -
mehr dazu189,00 € -
AAMI TIR97:2019/(R)2023
Principles for medical device security—Postmarket risk management for device manufacturers
01.01.2019 - PDF - Englisch -
mehr dazu285,00 € -
ANSI/AAMI/ISO 14117:2019/(R)2025
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 -
mehr dazu330,00 € -
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 -
mehr dazu153,00 € -
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 -
mehr dazu189,00 € -
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 -
mehr dazu234,00 € -
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 -
mehr dazu330,00 € -
ANSI/AAMI/ISO 11607-2:2019/A1:2023
Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management
01.01.2019 - PDF - Englisch -
mehr dazu153,00 € -
AAMI TIR75:2019
Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
01.01.2019 - PDF - Englisch -
mehr dazu234,00 € -
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 -
mehr dazu330,00 € -
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 -
mehr dazu234,00 € -
ANSI/AAMI/ISO 81060-2:2019
Non-invasive sphygmomanometers—Clinical investigation of intermittent automated measurement type
01.01.2019 - PDF - Englisch -
mehr dazu267,00 € -
ANSI/AAMI/ISO 14971:2019
Medical devices—Application of risk management to medical devices
01.01.2019 - PDF - Englisch -
mehr dazu285,00 € -
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 -
mehr dazu285,00 € -
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 -
mehr dazu153,00 € -
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 -
mehr dazu189,00 € -
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 -
mehr dazu354,00 € -
ANSI/AAMI/ISO 11737-1:2018/A1:2021
Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products—AMENDMENT 1
01.01.2018 - PDF - Englisch -
mehr dazu153,00 € -
189,00 € -
ANSI/AAMI/ISO 8637-3:2018
Extracorporeal systems for blood purification—Part 3: Plasmafilters
01.01.2018 - PDF - Englisch -
mehr dazu189,00 € -
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 -
mehr dazu285,00 € -
ANSI/AAMI/ISO 13408-2:2018
Aseptic processing of health care products—Part 2: Sterilizing filtration
01.01.2018 - PDF - Englisch -
mehr dazu153,00 € -
285,00 € -
AAMI/ISO TIR21900:2018
Guidance for uncertainty analysis regarding the application of ISO/TS 10974
01.01.2018 - PDF - Englisch -
mehr dazu153,00 € -
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 -
mehr dazu285,00 € -
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 -
mehr dazu285,00 € -
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 -
mehr dazu189,00 € -
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 -
mehr dazu234,00 € -
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 -
mehr dazu285,00 € -
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 -
mehr dazu234,00 € -
ANSI/AAMI ST90:2017/(R)2024
Processing of health care products—Quality management systems for processing in health care facilities
01.01.2017 - PDF - Englisch -
mehr dazu267,00 € -
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 -
mehr dazu189,00 € -
ANSI/AAMI/ISO 11138-3:2017/(R)2024
Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes
01.01.2017 - PDF - Englisch -
mehr dazu134,00 € -
AAMI TIR66:2017/(R)2025
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 -
mehr dazu234,00 € -
ANSI/AAMI/ISO 25539-1:2017
Cardiovascular implants— Endovascular devices—Part 1: Endovascular prostheses
01.01.2017 - PDF - Englisch -
mehr dazu234,00 € -
ANSI/AAMI/ISO 8637-1:2017
Extracorporeal systems for blood purification—Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
01.01.2017 - PDF - Englisch -
mehr dazu234,00 € -
ANSI/AAMI/ISO 11138-1:2017/(R)2024
Sterilization of health care products—Biological indicators—Part 1: General requirements
01.01.2017 - PDF - Englisch -
mehr dazu285,00 € -
ANSI/AAMI/ISO 10993-11:2017/(R)2023
Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
01.01.2017 - PDF - Englisch -
mehr dazu234,00 € -
AAMI/ISO TIR80002-2:2017
Medical device software—Part 2: Validation of software for medical device quality systems
01.01.2017 - PDF - Englisch -
mehr dazu330,00 € -
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 -
mehr dazu285,00 € -
ANSI/AAMI/ISO 11138-4:2017/(R)2024
Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes
01.01.2017 - PDF - Englisch -
mehr dazu134,00 € -
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 -
mehr dazu285,00 € -
153,00 € -
ANSI/AAMI/ISO 14708-3:2017
Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulators
01.01.2017 - PDF - Englisch -
mehr dazu267,00 € -
ANSI/AAMI CI86:2017/(R)2025
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
01.01.2017 - PDF - Englisch -
mehr dazu330,00 € -
ANSI/AAMI/ISO 11138-2:2017/(R)2024
Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes
01.01.2017 - PDF - Englisch -
mehr dazu134,00 € -
AAMI TIR21:2017/(R)2025
Systems used to forecast remaining pacemaker battery service life
01.01.2017 - PDF - Englisch -
mehr dazu257,00 € -
211,00 € -
153,00 € -
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 -
mehr dazu478,00 € -
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 -
mehr dazu153,00 € -
ANSI/AAMI/ISO 11138-5:2017/(R)2024
Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
01.01.2017 - PDF - Englisch -
mehr dazu134,00 € -
![ANSI/AAMI/ISO 16142-2:2017 [HISTORICAL]](https://www.normadoc.com/media/catalog/product/cache/3/small_image/95x95/9df78eab33525d08d6e5fb8d27136e95/a/1/a152e000006j63zqaa.png)
ANSI/AAMI/ISO 16142-2:2017 [HISTORICAL]
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 -
mehr dazu285,00 € -
AAMI TIR69:2017/(R)2020
Risk management of radio-frequency wireless coexistence for medical devices and systems
01.01.2017 - PDF - Englisch -
mehr dazu285,00 € -
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 -
mehr dazu189,00 € -
ANSI/AAMI/ISO 15675:2016
Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial blood line filters
01.01.2016 - PDF - Englisch -
mehr dazu134,00 € -
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 -
mehr dazu285,00 € -
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 -
mehr dazu134,00 € -
![ANSI/AAMI/ISO 16142-1:2016 [HISTORICAL]](https://www.normadoc.com/media/catalog/product/cache/3/small_image/95x95/9df78eab33525d08d6e5fb8d27136e95/a/1/a152e000006j63yqaa.png)
ANSI/AAMI/ISO 16142-1:2016 [HISTORICAL]
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 -
mehr dazu285,00 € -
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 -
mehr dazu234,00 € -
ANSI/AAMI/ISO 18242:2016
Cardiovascular implants and extracorporeal systems—Centrifugal blood pumps
01.01.2016 - PDF - Englisch -
mehr dazu153,00 € -
234,00 € -
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 -
mehr dazu134,00 € -
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 -
mehr dazu285,00 € -
285,00 € -
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 -
mehr dazu153,00 € -
AAMI/IEC TIR62366-2:2016
Medical devices—Part 2: Guidance on the application of usability engineering to medical devices
01.01.2016 - PDF - Englisch -
mehr dazu330,00 € -
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 -
mehr dazu285,00 € -
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 -
mehr dazu285,00 € -
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 -
mehr dazu153,00 € -
AAMI TIR28:2016/(R)2024
Product adoption and process equivalence for ethylene oxide sterilization
01.01.2016 - PDF - Englisch -
mehr dazu153,00 € -
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 -
mehr dazu153,00 € -
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 -
mehr dazu285,00 € -
ANSI/AAMI/ISO 7199:2016
Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators)
01.01.2016 - PDF - Englisch -
mehr dazu153,00 € -
153,00 € -
ANSI/AAMI/ISO 18241:2016
Cardiovascular implants and extracorporeal systems—Cardiopulmonary bypass systems—Venous bubble traps
01.01.2016 - PDF - Englisch -
mehr dazu189,00 € -
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 -
mehr dazu285,00 € -
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 -
mehr dazu234,00 € -
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 -
mehr dazu234,00 € -
189,00 € -
ANSI/AAMI/ISO 13485:2016/(R)2019
Medical devices—Quality management systems—Requirements for regulatory purposes
01.01.2016 - PDF - Englisch -
mehr dazu285,00 € -
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 -
mehr dazu234,00 € -
ANSI/AAMI/ISO 10993-6:2016
Biological evaluation of medical devices—Part 6: Tests for local effects after implantation
01.01.2016 - PDF - Englisch -
mehr dazu189,00 € -
330,00 € -
AAMI/IEC TIR60878:2015
Graphic symbols for electrical equipment in medical practice
01.01.2015 - PDF - Englisch -
mehr dazu510,00 € -
ANSI/AAMI EQ89:2015/(R)2023
Guidance for the use of medical equipment maintenance strategies and procedures
01.01.2015 - PDF - Englisch -
mehr dazu153,00 € -
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 -
mehr dazu396,00 € -
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 -
mehr dazu267,00 € -
AAMI TIR65:2015/(R)2022
Sustainability of medical devices—Elements of a responsible product life cycle
01.01.2015 - PDF - Englisch -
mehr dazu267,00 € -
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 -
mehr dazu285,00 € -
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 -
mehr dazu134,00 € -
537,00 € -
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 -
mehr dazu396,00 € -
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 -
mehr dazu330,00 € -
189,00 € -
AAMI TIR61:2014/(R)2025
Generating reports for human factors design validation results for external cardiac defibrillator
01.01.2014 - PDF - Englisch -
mehr dazu153,00 € -
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 -
mehr dazu267,00 € -
AAMI TIR62:2014/(R)2025
Generating reports for the purpose of submitting defibrillation waveform data for evaluation
01.01.2014 - PDF - Englisch -
mehr dazu134,00 € -
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 -
mehr dazu153,00 € -
AAMI TIR52:2014/(R)2022
Environmental monitoring for terminally sterilized healthcare products
01.01.2014 - PDF - Englisch -
mehr dazu134,00 € -
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 -
mehr dazu330,00 € -
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 -
mehr dazu234,00 € -
ANSI/AAMI/ISO TIR37137:2014
Cardiovascular biological evaluation of medical devices—Guidance for absorbable implants
01.01.2014 - PDF - Englisch -
mehr dazu153,00 € -
234,00 € -
ANSI/AAMI/ISO 10993-3:2014/(R)2023
Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
01.01.2014 - PDF - Englisch -
mehr dazu285,00 € -
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 -
mehr dazu153,00 € -
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 -
mehr dazu330,00 € -
ANSI/AAMI/ISO 11140-1:2014/(R)2025
Sterilization of health care products—Chemical indicators—Part 1: General requirements
01.01.2014 - PDF - Englisch -
mehr dazu189,00 € -
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 -
mehr dazu285,00 € -
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 -
mehr dazu153,00 € -
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 -
mehr dazu396,00 € -
153,00 € -
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 -
mehr dazu285,00 € -
153,00 € -
AAMI TIR56:2013/(R)2024
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 -
mehr dazu189,00 € -
AAMI TIR49:2013/(R)2020
Design of training and instructional materials for medical devices used in non-clinical environments
01.01.2013 - PDF - Englisch -
mehr dazu267,00 € -
153,00 € -
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 -
mehr dazu153,00 € -
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 -
mehr dazu285,00 €
