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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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
1/1/2023 - PDF - English - AAMI
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ANSI/AAMI SW96:2023
Standard for medical device security—Security risk management for device manufacturers
1/1/2023 - PDF - English - AAMI
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AAMI TIR34971:2023
Application of ISO 14971 to machine learning in artificial intelligence—Guide
1/1/2023 - PDF - English - AAMI
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AAMI TIR45:2023
Guidance on the use of AGILE practices in the development of medical device software
1/1/2023 - PDF - English - AAMI
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AAMI TIR45:2023 Redline
Guidance on the use of AGILE practices in the development of medical device software
1/1/2023 - PDF - English - AAMI
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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
1/1/2023 - PDF - English - AAMI
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AAMI/ISO TIR16775:2023
Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2
1/1/2023 - PDF - English - AAMI
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€303.00 -
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
1/1/2023 - PDF - English - AAMI
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€261.00
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ANSI/AAMI HIT1000-1:2022
Safety and effectiveness of health IT software and systems—Part 1: Fundamental concepts, principles, and requirements
1/1/2022 - PDF - English - AAMI
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AAMI TIR104:2022
Guidance on transferring health care products between radiation sterilization sources
1/1/2022 - PDF - English - AAMI
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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
1/1/2022 - PDF - English - AAMI
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ANSI/AAMI/UL 2800-1-1:2022
Standard for Risk Concerns for Interoperable Medical Products
1/1/2022 - PDF - English - AAMI
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€245.00 -
€215.00 -
€303.00 -
ANSI/AAMI/ISO 18472:2022
Sterilization of health care products—Biological and chemical indicators—Test equipment
1/1/2022 - PDF - English - AAMI
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ANSI/AAMI/ISO 5840-1:2022
Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements
1/1/2022 - PDF - English - AAMI
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ANSI/AAMI/ISO 5840-2:2022
Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes
1/1/2022 - PDF - English - AAMI
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ANSI/AAMI/ISO 5840-3:2022
Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques
1/1/2022 - PDF - English - AAMI
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ANSI/AAMI/ISO 15223-1:2022
Medical devices—Symbols to be used with information to be supplied by the manufacturer— Part 1: General requirements
1/1/2022 - PDF - English - AAMI
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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
1/1/2022 - PDF - English - AAMI
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ANSI/AAMI PB70:2022 Redline
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
1/1/2022 - PDF - English - AAMI
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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
1/1/2022 - PDF - English - AAMI
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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
1/1/2022 - PDF - English - AAMI
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ANSI/AAMI ST98:2022
Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices
1/1/2022 - PDF - English - AAMI
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AAMI/ISO TIR11137-4:2022/(R)2023
Sterilization of health care products—Radiation—Part 4: Guidance on process control
1/1/2022 - PDF - English - AAMI
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ANSI/AAMI PB70:2022
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
1/1/2022 - PDF - English - AAMI
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ANSI/AAMI/ISO 13004:2022
Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD
1/1/2022 - PDF - English - AAMI
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AAMI CR510:2021
Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
1/1/2021 - PDF - English - AAMI
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€261.00 -
ANSI/AAMI CN27:2021
General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
1/1/2021 - PDF - English - AAMI
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€245.00 -
ANSI/AAMI ST91:2021
Flexible and semi-rigid endoscope processing in health care facilities
1/1/2021 - PDF - English - AAMI
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AAMI TIR42:2021
Evaluation of particulate associated with vascular medical devices
1/1/2021 - PDF - English - AAMI
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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
1/1/2021 - PDF - English - AAMI
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AAMI TIR43:2021
Ultrapure dialysis fluid for hemodialysis and related therapies
1/1/2021 - PDF - English - AAMI
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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
1/1/2021 - PDF - English - AAMI
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AAMI TIR100:2021
End-to-end microbiological quality and sterility assurance
1/1/2021 - PDF - English - AAMI
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ANSI/AAMI/ISO 20417:2021
Medical devices—Information to be supplied by the manufacturer
1/1/2021 - PDF - English - AAMI
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AAMI/ISO TIR20416:2020
Medical devices—Post-market surveillance for manufacturers
1/1/2020 - PDF - English - AAMI
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€303.00 -
€261.00 -
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
1/1/2020 - PDF - English - AAMI
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AAMI HIT1000-4(PS):2020
Safety and effectiveness of health IT software and systems—Part 4: Application of human factors engineering
1/1/2020 - PDF - English - AAMI
Learn More€21.00 -
€245.00 -
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
1/1/2020 - PDF - English - AAMI
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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
1/1/2020 - PDF - English - AAMI
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ANSI/AAMI/ISO 10993-16:2020/(R)2022
Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
1/1/2020 - PDF - English - AAMI
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AAMI TIR12:2020/(R)2023
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
1/1/2020 - PDF - English - AAMI
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ANSI/AAMI/ISO 14155:2020
Clinical investigation of medical devices for human subjects—Good clinical practice
1/1/2020 - PDF - English - AAMI
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AAMI/ISO TIR10993-19:2020
Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
1/1/2020 - PDF - English - AAMI
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ANSI/AAMI ST72:2019
Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing
11/1/2019 - PDF - English - AAMI
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AAMI TIR97:2019/(R)2023
Principles for medical device security—Postmarket risk management for device manufacturers
1/1/2019 - PDF - English - AAMI
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AAMI HIT1000-3(PS):2019
Safety and effectiveness of health IT software and systems—Part 3: Application of risk management
1/1/2019 - PDF - English - AAMI
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AAMI TIR102:2019
U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
1/1/2019 - PDF - English - AAMI
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€261.00 -
AAMI TIR75:2019
Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
1/1/2019 - PDF - English - AAMI
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ANSI/AAMI EQ93:2019
Medical equipment management—Vocabulary used in medical equipment programs
1/1/2019 - PDF - English - AAMI
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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
1/1/2019 - PDF - English - AAMI
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ANSI/AAMI ST67:2019
Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled —sterile—
1/1/2019 - PDF - English - AAMI
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ANSI/AAMI/ISO 11138-7:2019
Sterilization of health care products—Biological indicators—Part 7: Guidance for the selection, use and interpretation of results
1/1/2019 - PDF - English - AAMI
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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
1/1/2019 - PDF - English - AAMI
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ANSI/AAMI/ISO 11607-1:2019
Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems
1/1/2019 - PDF - English - AAMI
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ANSI/AAMI/ISO 11607-2:2019
Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes
1/1/2019 - PDF - English - AAMI
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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
1/1/2019 - PDF - English - AAMI
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ANSI/AAMI/ISO 14971:2019
Medical devices—Application of risk management to medical devices
1/1/2019 - PDF - English - AAMI
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ANSI/AAMI/ISO 23500-1:2019
Preparation and quality management of fluids for haemodialysis and related therapies—Part 1: General requirements
1/1/2019 - PDF - English - AAMI
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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
1/1/2019 - PDF - English - AAMI
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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
1/1/2019 - PDF - English - AAMI
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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
1/1/2019 - PDF - English - AAMI
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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
1/1/2019 - PDF - English - AAMI
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ANSI/AAMI/ISO 81060-2:2019
Non-invasive sphygmomanometers—Clinical investigation of intermittent automated measurement type
1/1/2019 - PDF - English - AAMI
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€174.00 -
ANSI/AAMI/ISO 10993-15:2019
Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys
1/1/2019 - PDF - English - AAMI
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AAMI TIR40:2018/(R)2022
Sterilization of health care products—Radiation—Guidance on dose setting utilizing a Modified Method 2
1/1/2018 - PDF - English - AAMI
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€174.00 -
AAMI/ISO TIR10974:2018
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
1/1/2018 - PDF - English - AAMI
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AAMI/ISO TIR21900:2018
Guidance for uncertainty analysis regarding the application of ISO/TS 10974
1/1/2018 - PDF - English - AAMI
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€261.00 -
ANSI/AAMI/ISO 10993-1:2018
Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
1/1/2018 - PDF - English - AAMI
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ANSI/AAMI/ISO 11737-1:2018
Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products
1/1/2018 - PDF - English - AAMI
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ANSI/AAMI/ISO 13408-2:2018
Aseptic processing of health care products—Part 2: Sterilizing filtration
1/1/2018 - PDF - English - AAMI
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ANSI/AAMI/ISO 80369-1:2018
Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements
1/1/2018 - PDF - English - AAMI
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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
1/1/2018 - PDF - English - AAMI
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ANSI/AAMI/ISO 8637-3:2018
Extracorporeal systems for blood purification—Part 3: Plasmafilters
1/1/2018 - PDF - English - AAMI
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ANSI/AAMI/ISO 8637-2:2018
Extracorporeal systems for blood purification— Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
1/1/2018 - PDF - English - AAMI
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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
1/1/2018 - PDF - English - AAMI
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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
1/1/2018 - PDF - English - AAMI
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AAMI TIR67:2018/(R)2022
Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
1/1/2018 - PDF - English - AAMI
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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
1/1/2018 - PDF - English - AAMI
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AAMI TIR21:2017/(R)2020
Systems used to forecast remaining pacemaker battery service life
1/1/2017 - PDF - English - AAMI
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AAMI TIR69:2017/(R)2020
Risk management of radio-frequency wireless coexistence for medical devices and systems
1/1/2017 - PDF - English - AAMI
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€141.00 -
ANSI/AAMI CI86:2017
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
1/1/2017 - PDF - English - AAMI
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AAMI/ISO TIR15499:2017
Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process
1/1/2017 - PDF - English - AAMI
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AAMI/ISO TIR80002-2:2017
Medical device software—Part 2: Validation of software for medical device quality systems
1/1/2017 - PDF - English - AAMI
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ANSI/AAMI ST90:2017
Processing of health care products—Quality management systems for processing in health care facilities
1/1/2017 - PDF - English - AAMI
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ANSI/AAMI/ISO 10993-11:2017/(R)2023
Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
1/1/2017 - PDF - English - AAMI
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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
1/1/2017 - PDF - English - AAMI
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ANSI/AAMI/ISO 10993-4:2017
Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
1/1/2017 - PDF - English - AAMI
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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
1/1/2017 - PDF - English - AAMI
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ANSI/AAMI/ISO 11138-1:2017
Sterilization of health care products—Biological indicators—Part 1: General requirements
1/1/2017 - PDF - English - AAMI
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ANSI/AAMI/ISO 11138-2:2017
Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes
1/1/2017 - PDF - English - AAMI
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ANSI/AAMI/ISO 11138-3:2017
Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes
1/1/2017 - PDF - English - AAMI
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ANSI/AAMI/ISO 11138-4:2017
Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes
1/1/2017 - PDF - English - AAMI
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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
1/1/2017 - PDF - English - AAMI
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ANSI/AAMI/ISO 14708-3:2017
Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulators
1/1/2017 - PDF - English - AAMI
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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
1/1/2017 - PDF - English - AAMI
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ANSI/AAMI/ISO 25539-1:2017
Cardiovascular implants— Endovascular devices—Part 1: Endovascular prostheses
1/1/2017 - PDF - English - AAMI
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€215.00 -
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
1/1/2017 - PDF - English - AAMI
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€141.00 -
ANSI/AAMI/ISO 8637-1:2017
Extracorporeal systems for blood purification—Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
1/1/2017 - PDF - English - AAMI
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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
1/1/2017 - PDF - English - AAMI
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€303.00 -
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
1/1/2016 - PDF - English - AAMI
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€303.00 -
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
1/1/2016 - PDF - English - AAMI
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AAMI/IEC TIR80002-3:2016
Medical Device Software—Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
1/1/2016 - PDF - English - AAMI
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€215.00 -
ANSI/AAMI/ISO 10993-6:2016
Biological evaluation of medical devices—Part 6: Tests for local effects after implantation
1/1/2016 - PDF - English - AAMI
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ANSI/AAMI/ISO 13485:2016/(R)2019
Medical devices—Quality management systems—Requirements for regulatory purposes
1/1/2016 - PDF - English - AAMI
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ANSI/AAMI/ISO 15674:2016
Cardiovascular implants and artificial organs—Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
1/1/2016 - PDF - English - AAMI
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ANSI/AAMI/ISO 15675:2016
Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial blood line filters
1/1/2016 - PDF - English - AAMI
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ANSI/AAMI/ISO 15676:2016
Cardiovascular implants and artificial organs—Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
1/1/2016 - PDF - English - AAMI
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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
1/1/2016 - PDF - English - AAMI
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ANSI/AAMI/ISO 18241:2016
Cardiovascular implants and extracorporeal systems—Cardiopulmonary bypass systems—Venous bubble traps
1/1/2016 - PDF - English - AAMI
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ANSI/AAMI/ISO 18242:2016
Cardiovascular implants and extracorporeal systems—Centrifugal blood pumps
1/1/2016 - PDF - English - AAMI
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ANSI/AAMI/ISO 22442-1:2016
Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management
1/1/2016 - PDF - English - AAMI
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ANSI/AAMI/ISO 22442-2:2016
Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and handling
1/1/2016 - PDF - English - AAMI
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ANSI/AAMI/ISO 80369-3:2016
Small-bore connectors for liquids and gases in healthcare applications—Part 3: connectors for enteral applications
1/1/2016 - PDF - English - AAMI
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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
1/1/2016 - PDF - English - AAMI
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ANSI/AAMI/ISO 80369-5:2016
Small-bore connectors for liquids and gases in healthcare applications—Part 5: Connectors for limb cuff inflation applications
1/1/2016 - PDF - English - AAMI
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ANSI/AAMI/ISO 80369-6:2016
Small-bore connectors for liquids and gases in healthcare applications—Part 6: Connectors for neuraxial applications
1/1/2016 - PDF - English - AAMI
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ANSI/AAMI/ISO 80369-7:2016
Small-bore connectors for liquids and gases in healthcare applications—Part 7: Connectors for intravascular or hypodermic applications
1/1/2016 - PDF - English - AAMI
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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
1/1/2016 - PDF - English - AAMI
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€261.00 -
ANSI/AAMI/ISO 7199:2016
Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators)
1/1/2016 - PDF - English - AAMI
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AAMI/IEC TIR62366-2:2016
Medical devices—Part 2: Guidance on the application of usability engineering to medical devices
1/1/2016 - PDF - English - AAMI
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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.
1/1/2016 - PDF - English - AAMI
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€141.00 -
AAMI TIR28:2016/(R)2020
Product adoption and process equivalence for ethylene oxide sterilization
1/1/2016 - PDF - English - AAMI
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€174.00 -
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
1/1/2016 - PDF - English - AAMI
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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
1/1/2016 - PDF - English - AAMI
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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
1/1/2016 - PDF - English - AAMI
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AAMI TIR65:2015/(R)2022
Sustainability of medical devices—Elements of a responsible product life cycle
1/1/2015 - PDF - English - AAMI
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AAMI/IEC TIR60878:2015
Graphic symbols for electrical equipment in medical practice
1/1/2015 - PDF - English - AAMI
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ANSI/AAMI EQ89:2015/(R)2023
Guidance for the use of medical equipment maintenance strategies and procedures
1/1/2015 - PDF - English - AAMI
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ANSI/AAMI/ISO 80369-20:2015
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
1/1/2015 - PDF - English - AAMI
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ANSI/AAMI/IEC TIR62354:2015
General testing procedures for medical electrical equipment
1/1/2015 - PDF - English - AAMI
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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.
1/1/2015 - PDF - English - AAMI
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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
1/1/2015 - PDF - English - AAMI
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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
1/1/2015 - PDF - English - AAMI
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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
1/1/2015 - PDF - English - AAMI
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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
1/1/2015 - PDF - English - AAMI
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AAMI TIR62:2014/(R)2019
Generating reports for the purpose of submitting defibrillation waveform data for evaluation
1/1/2014 - PDF - English - AAMI
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AAMI TIR52:2014/(R)2022
Environmental monitoring for terminally sterilized healthcare products
1/1/2014 - PDF - English - AAMI
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€174.00 -
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
1/1/2014 - PDF - English - AAMI
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€141.00 -
AAMI TIR61:2014/(R)2019
Generating reports for human factors design validation results for external cardiac defibrillator
1/1/2014 - PDF - English - AAMI
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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
1/1/2014 - PDF - English - AAMI
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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
1/1/2014 - PDF - English - AAMI
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ANSI/AAMI/ISO 10993-3:2014/(R)2023
Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
1/1/2014 - PDF - English - AAMI
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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
1/1/2014 - PDF - English - AAMI
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€141.00 -
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
1/1/2014 - PDF - English - AAMI
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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
1/1/2014 - PDF - English - AAMI
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ANSI/AAMI/ISO 11140-1:2014
Sterilization of health care products—Chemical indicators—Part 1: General requirements
1/1/2014 - PDF - English - AAMI
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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
1/1/2014 - PDF - English - AAMI
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ANSI/AAMI/ISO TIR37137:2014
Cardiovascular biological evaluation of medical devices—Guidance for absorbable implants
1/1/2014 - PDF - English - AAMI
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€215.00 -
AAMI TIR51:2014/(R)2017
Human factors engineering—Guidance for contextual inquiry
1/1/2014 - PDF - English - AAMI
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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
1/1/2014 - PDF - English - AAMI
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AAMI/ISO TIR80001-2-6:2014
Application of risk management for IT-networks incorporating medical—Application guidance—Part 2-6: Guidance for responsibility agreements
1/1/2014 - PDF - English - AAMI
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AAMI TIR63:2014/(R)2023
Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
1/1/2014 - PDF - English - AAMI
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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
1/1/2014 - PDF - English - AAMI
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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
1/1/2014 - PDF - English - AAMI
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€141.00 -
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.
1/1/2013 - PDF - English - AAMI
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ANSI/AAMI ST58:2013/(R)2018
Chemical sterilization and high-level disinfection in health care facilities
1/1/2013 - PDF - English - AAMI
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ANSI/AAMI ST77:2013/(R)2018
Containment devices for reusable medical device sterilization
1/1/2013 - PDF - English - AAMI
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ANSI/AAMI/ISO 11137-2:2013/(R)2019
Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose
1/1/2013 - PDF - English - AAMI
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€215.00 -
AAMI TIR49:2013/(R)2020
Design of training and instructional materials for medical devices used in non-clinical environments
1/1/2013 - PDF - English - AAMI
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ANSI/AAMI EQ56:2013
Recommended practice for a medical equipment management program
1/1/2013 - PDF - English - AAMI
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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
1/1/2013 - PDF - English - AAMI
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€141.00 -
AAMI TIR44:2012
Non-invasive blood pressure motion artifact—Testing and evaluation of NIBP device performance in the presence of motion artifact
1/1/2012 - PDF - English - AAMI
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AAMI/IEC TIR80001-2-3:2012
Application of risk management for IT-networks incorporating medical devices—Part 2-3: Guidance for wireless networks
1/1/2012 - PDF - English - AAMI
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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.
1/1/2012 - PDF - English - AAMI
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AAMI/ISO TIR23810:2012/(R)2015
Cardiovascular implants and artificial organs—Checklist for preoperative extracorporeal circulation equipment setup
1/1/2012 - PDF - English - AAMI
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ANSI/AAMI PB70:2012 Red-Line
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
1/1/2012 - PDF - English - AAMI
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ANSI/AAMI ST15883-3:2012/(R)2023
Washer-disinfectors—Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
1/1/2012 - PDF - English - AAMI
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ANSI/AAMI/ISO 10993-12:2012
Biological evaluation of medical devices—Part 12: Sample preparation and reference materials
1/1/2012 - PDF - English - AAMI
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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
1/1/2012 - PDF - English - AAMI
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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.
1/1/2012 - PDF - English - AAMI
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