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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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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€303.00 -
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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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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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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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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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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ANSI/AAMI ST91:2021
Flexible and semi-rigid endoscope processing in health care facilities
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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€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
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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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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 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
Learn More€21.00 -
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 ST72:2019
Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing
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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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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€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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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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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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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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€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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€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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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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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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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 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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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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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/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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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 -
ANSI/AAMI EQ56:2013
Recommended practice for a medical equipment management program
1/1/2013 - PDF - English - AAMI
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€141.00 -
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
Learn More€261.00 -
ANSI/AAMI ST15883-3:2012/(R)2023
Washer-disinfectors—Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
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/ISO 13408-7:2012/(R)2018
Aseptic processing of health care products—Part 7: Alternative processes for medical devices and combination products
1/1/2012 - PDF - English - AAMI
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ANSI/AAMI/ISO 11658:2012
Cardiovascular implants and extracorporeal systems—Blood/tissue contact surface modifications for extracorporeal perfusion systems
1/1/2012 - PDF - English - AAMI
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ANSI/AAMI/ISO 13022:2012
Medical products containing viable human cells—Application of risk management and requirements for processing practices
1/1/2012 - PDF - English - AAMI
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ANSI/AAMI/ISO 25539-2:2012
Cardiovascular implants—Endovascular devices—Part 2: Vascular stents
1/1/2012 - PDF - English - AAMI
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ANSI/AAMI/ISO 27185:2012/(R)2017
Cardiac rhythm management devices—Symbols to be used with cardiac rhythm management device labels, and information to be supplied—General requirements
1/1/2012 - PDF - English - AAMI
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ANSI/AAMI EC57:2012/(R)2020
Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms
1/1/2012 - PDF - English - AAMI
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ANSI/AAMI/IEC 60601-2-25:2011/(R)2016
Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
1/1/2011 - PDF - English - AAMI
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ANSI/AAMI/IEC 60601-2-27:2011/(R)2016
Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
1/1/2011 - PDF - English - AAMI
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ANSI/AAMI/ISO 14160:2011/(R)2016
Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization proces
1/1/2011 - PDF - English - AAMI
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ANSI/AAMI/ISO 25539-3:2011/(R)2015
Cardiovascular implants—Endovascular devices—Part 3: Vena Cava Filters
1/1/2011 - PDF - English - AAMI
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ANSI/AAMI/ISO 10993-10:2010/(R)2014
Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization
1/1/2010 - PDF - English - AAMI
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ANSI/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
1/1/2010 - PDF - English - AAMI
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ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Redline Version)
Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
1/1/2010 - PDF - English - AAMI
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ANSI/AAMI/IEC 80001-1:2010
Application of risk management for IT Networks incorporating medical devices—Part 1: Roles, responsibilities and activities.
1/1/2010 - PDF - English - AAMI
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ANSI/AAMI/ISO 15223-2:2010/(R)2016
Medical devices—Symbols to be used with medical device labels, labeling and information to be supplied—Part 2: Symbol development, selection and validation
1/1/2010 - PDF - English - AAMI
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ANSI/AAMI/ISO 20857:2010/(R)2015
Sterilization of health care products—Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices
1/1/2010 - PDF - English - AAMI
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ANSI/AAMI ST15883-1:2009/(R)2023 & A1:2014 & A2:2012
(Consolidated Text) (ISO 15883-1:2006, MOD) Washer-disinfectors—Part 1: General requirements, terms and definitions and tests
1/1/2009 - PDF - English - AAMI
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ANSI/AAMI/IEC 60601-2-19:2009/(R)2014 & A1:2016
Medical Electrical Equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
1/1/2009 - PDF - English - AAMI
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ANSI/AAMI/IEC 60601-2-20:2009/(R)2014 & A1:2016
Medical Electrical Equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
1/1/2009 - PDF - English - AAMI
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ANSI/AAMI/IEC 60601-2-21:2009/(R)2014 & A1:2016
Medical Electrical Equipment—Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
1/1/2009 - PDF - English - AAMI
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ANSI/AAMI/IEC 60601-2-50:2009/(R)2014 & A1:2016
Medical electrical equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
1/1/2009 - PDF - English - AAMI
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ANSI/AAMI/ISO 10993-5:2009/(R)2022
Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity
1/1/2009 - PDF - English - AAMI
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ANSI/AAMI/ISO 10993-9:2009/(R)2014
Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products
1/1/2009 - PDF - English - AAMI
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ANSI/AAMI/ISO 14937:2009/(R)2013
Sterilization of health care products—General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
1/1/2009 - PDF - English - AAMI
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€459.00 -
ANSI/AAMI ST41:2008/(R)2018
Ethylene oxide sterilization in health care facilities: Safety and effectiveness
1/1/2008 - PDF - English - AAMI
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ANSI/AAMI ST65:2008/(R)2018
Processing of reusable surgical textiles for use in health care facilities
1/1/2008 - PDF - English - AAMI
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ANSI/AAMI/ISO 10993-7:2008/(R)2012
Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
1/1/2008 - PDF - English - AAMI
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ANSI/AAMI/ISO 14708-4:2008/(R)2011
Implants for surgery—Active implantable medical devices—Part 4: Implantable infusion pumps
1/1/2008 - PDF - English - AAMI
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ANSI/AAMI/ISO 13408-1:2008/(R)2017 & A1:2013/(R)2017
Aseptic processing of health care products—Part 1: General requirements (includes Amendment 1)
1/1/2008 - PDF - English - AAMI
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ANSI/AAMI/ISO 15882:2008/(R)2013
Sterilization of health care products—Chemical indicators—Guidance for selection, use and interpretation of results
1/1/2008 - PDF - English - AAMI
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ANSI/AAMI/ISO 11140-3:2007/(R)2015
Sterilization of health care products—Chemical indicators—Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test
1/1/2007 - PDF - English - AAMI
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ANSI/AAMI/ISO 11140-4:2007/(R)2015
Sterilization of health care products—Chemical indicators—Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration
1/1/2007 - PDF - English - AAMI
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ANSI/AAMI/ISO 11140-5:2007/(R)2015
Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs
1/1/2007 - PDF - English - AAMI
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ANSI/AAMI/ISO 22442-3:2007/(R)2016
Medical devices utilizing animal tissues and their derivatives—Part 3: Validation of the elimination and/or inactivation of viruses and transimissible spongiform encephalopathy (TSE) agents
1/1/2007 - PDF - English - AAMI
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ANSI/AAMI/ISO 81060-1:2007/(R)2013
Non invasive sphygmomanometers—Part 1: Requirements and test methods for nonautomated measurement type
1/1/2007 - PDF - English - AAMI
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ANSI/AAMI/ISO 10993-2:2006/(R)2014
Biological evaluation of medical devices—Part 2: Animal welfare requirements
1/1/2006 - PDF - English - AAMI
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ANSI/AAMI BE83:2006/(R)2011
Biological evaluation of medical devices—Part 18: Chemical characterization of materials
1/1/2006 - PDF - English - AAMI
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€303.00 -
€261.00 -
ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019
Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
1/1/2006 - PDF - English - AAMI
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ANSI/AAMI/ISO 13408-3:2006/(R)2015
Aseptic processing of health care products—Part 3: Lyophilization
1/1/2006 - PDF - English - AAMI
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ANSI/AAMI/ISO 13408-5:2006/(R)2015
Aseptic processing of health care products—Part 5: Sterilization in place
1/1/2006 - PDF - English - AAMI
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ANSI/AAMI/ISO 17665-1:2006/(R)2013
Sterilization of health care products—Moist heat—Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices
1/1/2006 - PDF - English - AAMI
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ANSI/AAMI/IEC 60601-1-8:2006/A2:2021
Medical Electrical Equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems, Amend. 2
1/1/2006 - PDF - English - AAMI
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ANSI/AAMI/IEC 60601-1-8:2006 & A1:2013 & A2:2021 Redline
Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, test and guidance for alarm systems in medical electrical equipment and medical electrical systems
1/1/2006 - PDF - English - AAMI
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ANSI/AAMI/ISO 13408-4:2005/(R)2014
Aseptic processing of health care products—Part 4: Clean-in-place technologies
1/1/2005 - PDF - English - AAMI
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ANSI/AAMI/ISO 13408-6:2005/(R)2013 & A1:2013
Aseptic processing of health care products—Part 6: Isolator systems (Includes Amendment 1)
1/1/2005 - PDF - English - AAMI
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ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012 & A2:2021 Redline
Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
1/1/2005 - PDF - English - AAMI
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ANSI/AAMI ST40:2004/(R)2018
Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
1/1/2004 - PDF - English - AAMI
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€174.00 -
ANSI/AAMI/ISO 10993-17:2002/(R)2012
Biological evaluation of medical devices—Part 17: Establishment of allowable limits for leachable substances
1/1/2002 - PDF - English - AAMI
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ANSI/AAMI/ISO 10993-14:2001/(R)2019
Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics
1/1/2001 - PDF - English - AAMI
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€141.00 -
ANSI/AAMI ST24:1999/(R)2018
Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
1/1/1999 - PDF - English - AAMI
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€141.00
