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
01.01.2023 - PDF - Englisch - AAMI
mehr dazu123,00 € -
ANSI/AAMI SW96:2023
Standard for medical device security—Security risk management for device manufacturers
01.01.2023 - PDF - Englisch - AAMI
mehr dazu261,00 € -
AAMI TIR34971:2023
Application of ISO 14971 to machine learning in artificial intelligence—Guide
01.01.2023 - PDF - Englisch - AAMI
mehr dazu215,00 € -
AAMI TIR45:2023
Guidance on the use of AGILE practices in the development of medical device software
01.01.2023 - PDF - Englisch - AAMI
mehr dazu303,00 € -
AAMI TIR45:2023 Redline
Guidance on the use of AGILE practices in the development of medical device software
01.01.2023 - PDF - Englisch - AAMI
mehr dazu303,00 € -
ANSI/AAMI/ISO 11138-8:2023
Sterilization of health care products—Biological indicators—Part 8: Method for validation of a reduced incubation item for a biological indicator
01.01.2023 - PDF - Englisch - AAMI
mehr dazu141,00 € -
AAMI/ISO TIR16775:2023
Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2
01.01.2023 - PDF - Englisch - AAMI
mehr dazu364,00 € -
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
01.01.2023 - PDF - Englisch - AAMI
mehr dazu174,00 € -
AAMI TIR16:2023
Microbiological aspects of ethylene oxide sterilization
01.01.2023 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI HIT1000-1:2022
Safety and effectiveness of health IT software and systems—Part 1: Fundamental concepts, principles, and requirements
01.01.2022 - PDF - Englisch - AAMI
mehr dazu245,00 € -
AAMI TIR104:2022
Guidance on transferring health care products between radiation sterilization sources
01.01.2022 - PDF - Englisch - AAMI
mehr dazu215,00 € -
ANSI/AAMI 2700-2-1:2022
Medical devices and medical systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging
01.01.2022 - PDF - Englisch - AAMI
mehr dazu245,00 € -
ANSI/AAMI/UL 2800-1-1:2022
Standard for Risk Concerns for Interoperable Medical Products
01.01.2022 - PDF - Englisch - AAMI
mehr dazu261,00 € -
245,00 € -
215,00 € -
303,00 € -
ANSI/AAMI/ISO 18472:2022
Sterilization of health care products—Biological and chemical indicators—Test equipment
01.01.2022 - PDF - Englisch - AAMI
mehr dazu245,00 € -
ANSI/AAMI/ISO 5840-1:2022
Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements
01.01.2022 - PDF - Englisch - AAMI
mehr dazu303,00 € -
ANSI/AAMI/ISO 5840-2:2022
Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes
01.01.2022 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 5840-3:2022
Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques
01.01.2022 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 15223-1:2022
Medical devices—Symbols to be used with information to be supplied by the manufacturer— Part 1: General requirements
01.01.2022 - PDF - Englisch - AAMI
mehr dazu245,00 € -
AAMI/ISO TIR22456:2022
Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
01.01.2022 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI PB70:2022 Redline
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
01.01.2022 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 17664-1:2022
Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices
01.01.2022 - PDF - Englisch - AAMI
mehr dazu215,00 € -
ANSI/AAMI/ISO 17664-2:2022
Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices
01.01.2022 - PDF - Englisch - AAMI
mehr dazu215,00 € -
ANSI/AAMI ST98:2022
Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices
01.01.2022 - PDF - Englisch - AAMI
mehr dazu245,00 € -
AAMI/ISO TIR11137-4:2022/(R)2023
Sterilization of health care products—Radiation—Part 4: Guidance on process control
01.01.2022 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI PB70:2022
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
01.01.2022 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 13004:2022
Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD
01.01.2022 - PDF - Englisch - AAMI
mehr dazu261,00 € -
AAMI CR510:2021
Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
01.01.2021 - PDF - Englisch - AAMI
mehr dazu123,00 € -
261,00 € -
ANSI/AAMI CN27:2021
General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
01.01.2021 - PDF - Englisch - AAMI
mehr dazu215,00 € -
245,00 € -
ANSI/AAMI ST91:2021
Flexible and semi-rigid endoscope processing in health care facilities
01.01.2021 - PDF - Englisch - AAMI
mehr dazu353,00 € -
AAMI TIR42:2021
Evaluation of particulate associated with vascular medical devices
01.01.2021 - PDF - Englisch - AAMI
mehr dazu245,00 € -
ANSI/AAMI PC76:2021
Active implantable medical devices— Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
01.01.2021 - PDF - Englisch - AAMI
mehr dazu303,00 € -
AAMI TIR43:2021
Ultrapure dialysis fluid for hemodialysis and related therapies
01.01.2021 - PDF - Englisch - AAMI
mehr dazu245,00 € -
AAMI TIR76:2021
Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmax SD-S
01.01.2021 - PDF - Englisch - AAMI
mehr dazu245,00 € -
AAMI TIR100:2021
End-to-end microbiological quality and sterility assurance
01.01.2021 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI/ISO 20417:2021
Medical devices—Information to be supplied by the manufacturer
01.01.2021 - PDF - Englisch - AAMI
mehr dazu303,00 € -
AAMI/ISO TIR20416:2020
Medical devices—Post-market surveillance for manufacturers
01.01.2020 - PDF - Englisch - AAMI
mehr dazu245,00 € -
AAMI/ISO TIR24971:2020
Medical devices—Guidance on the application of ISO 14971
01.01.2020 - PDF - Englisch - AAMI
mehr dazu303,00 € -
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
01.01.2020 - PDF - Englisch - AAMI
mehr dazu245,00 € -
AAMI HIT1000-4(PS):2020
Safety and effectiveness of health IT software and systems—Part 4: Application of human factors engineering
01.01.2020 - PDF - Englisch - AAMI
mehr dazu21,00 € -
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
01.01.2020 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/IEC 80601-2-78:2020
Medical electrical equipment—Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
01.01.2020 - PDF - Englisch - AAMI
mehr dazu261,00 € -
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 - AAMI
mehr dazu141,00 € -
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 - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 14155:2020
Clinical investigation of medical devices for human subjects—Good clinical practice
01.01.2020 - PDF - Englisch - AAMI
mehr dazu303,00 € -
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 - AAMI
mehr dazu174,00 € -
ANSI/AAMI ST72:2019
Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing
01.11.2019 - PDF - Englisch - AAMI
mehr dazu261,00 € -
AAMI TIR97:2019/(R)2023
Principles for medical device security—Postmarket risk management for device manufacturers
01.01.2019 - PDF - Englisch - AAMI
mehr dazu261,00 € -
AAMI HIT1000-3(PS):2019
Safety and effectiveness of health IT software and systems—Part 3: Application of risk management
01.01.2019 - PDF - Englisch - AAMI
mehr dazu21,00 € -
AAMI TIR102:2019
U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
01.01.2019 - PDF - Englisch - AAMI
mehr dazu303,00 € -
261,00 € -
AAMI TIR75:2019
Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
01.01.2019 - PDF - Englisch - AAMI
mehr dazu215,00 € -
ANSI/AAMI EQ93:2019
Medical equipment management—Vocabulary used in medical equipment programs
01.01.2019 - PDF - Englisch - AAMI
mehr dazu123,00 € -
ANSI/AAMI 2700-1:2019
Medical Devices and Medical Systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model
01.01.2019 - PDF - Englisch - AAMI
mehr dazu215,00 € -
ANSI/AAMI ST67:2019
Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled —sterile—
01.01.2019 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI/ISO 11138-7:2019
Sterilization of health care products—Biological indicators—Part 7: Guidance for the selection, use and interpretation of results
01.01.2019 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 14117:2019
Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
01.01.2019 - PDF - Englisch - AAMI
mehr dazu303,00 € -
ANSI/AAMI/ISO 11607-1:2019
Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems
01.01.2019 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI/ISO 11607-2:2019
Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes
01.01.2019 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI/ISO 11737-2:2019
Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
01.01.2019 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI/ISO 14971:2019
Medical devices—Application of risk management to medical devices
01.01.2019 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 23500-1:2019
Preparation and quality management of fluids for haemodialysis and related therapies—Part 1: General requirements
01.01.2019 - PDF - Englisch - AAMI
mehr dazu303,00 € -
ANSI/AAMI/ISO 23500-2:2019
Preparation and quality management of fluids for haemodialysis and related therapies—Part 2: Water treatment equipment for haemodialysis applications and related therapies
01.01.2019 - PDF - Englisch - AAMI
mehr dazu245,00 € -
ANSI/AAMI/ISO 23500-3:2019
Preparation and quality management of fluids for haemodialysis and related therapies—Part 3: Water for haemodialysis and related therapies
01.01.2019 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI/ISO 23500-4:2019
Preparation and quality management of fluids for haemodialysis and related therapies—Part 4: Concentrates for haemodialysis and related therapies
01.01.2019 - PDF - Englisch - AAMI
mehr dazu215,00 € -
ANSI/AAMI/ISO 23500-5:2019
Preparation and quality management of fluids for haemodialysis and related therapies—Part 5: Quality of dialysis fluid for haemodialysis and related therapies
01.01.2019 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI/ISO 81060-2:2019
Non-invasive sphygmomanometers—Clinical investigation of intermittent automated measurement type
01.01.2019 - PDF - Englisch - AAMI
mehr dazu245,00 € -
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
01.01.2019 - PDF - Englisch - AAMI
mehr dazu141,00 € -
AAMI TIR40:2018/(R)2022
Sterilization of health care products—Radiation—Guidance on dose setting utilizing a Modified Method 2
01.01.2018 - PDF - Englisch - AAMI
mehr dazu174,00 € -
174,00 € -
AAMI/ISO TIR10974:2018
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
01.01.2018 - PDF - Englisch - AAMI
mehr dazu325,00 € -
AAMI/ISO TIR21900:2018
Guidance for uncertainty analysis regarding the application of ISO/TS 10974
01.01.2018 - PDF - Englisch - AAMI
mehr dazu141,00 € -
261,00 € -
ANSI/AAMI/ISO 10993-1:2018
Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
01.01.2018 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 11737-1:2018
Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products
01.01.2018 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 13408-2:2018
Aseptic processing of health care products—Part 2: Sterilizing filtration
01.01.2018 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI/ISO 80369-1:2018
Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements
01.01.2018 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI/IEC 80601-2-30:2018
Medical electrical equipment—Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
01.01.2018 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 8637-3:2018
Extracorporeal systems for blood purification—Part 3: Plasmafilters
01.01.2018 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI/ISO 8637-2:2018
Extracorporeal systems for blood purification— Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
01.01.2018 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI/IEC 60601-2-16:2018
Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
01.01.2018 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/IEC 60601-2-39:2018
Medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
01.01.2018 - PDF - Englisch - AAMI
mehr dazu215,00 € -
AAMI TIR67:2018/(R)2022
Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
01.01.2018 - PDF - Englisch - AAMI
mehr dazu261,00 € -
AAMI TIR68:2018/(R)2022
Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
01.01.2018 - PDF - Englisch - AAMI
mehr dazu215,00 € -
AAMI TIR21:2017/(R)2020
Systems used to forecast remaining pacemaker battery service life
01.01.2017 - PDF - Englisch - AAMI
mehr dazu261,00 € -
AAMI TIR69:2017/(R)2020
Risk management of radio-frequency wireless coexistence for medical devices and systems
01.01.2017 - PDF - Englisch - AAMI
mehr dazu261,00 € -
141,00 € -
ANSI/AAMI CI86:2017
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
01.01.2017 - PDF - Englisch - AAMI
mehr dazu303,00 € -
AAMI/ISO TIR15499:2017
Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process
01.01.2017 - PDF - Englisch - AAMI
mehr dazu174,00 € -
AAMI/ISO TIR80002-2:2017
Medical device software—Part 2: Validation of software for medical device quality systems
01.01.2017 - PDF - Englisch - AAMI
mehr dazu303,00 € -
ANSI/AAMI ST90:2017
Processing of health care products—Quality management systems for processing in health care facilities
01.01.2017 - PDF - Englisch - AAMI
mehr dazu245,00 € -
ANSI/AAMI/ISO 10993-11:2017/(R)2023
Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
01.01.2017 - PDF - Englisch - AAMI
mehr dazu215,00 € -
ANSI/AAMI/IEC 60601-2-2:2017
Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
01.01.2017 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 10993-4:2017
Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
01.01.2017 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 11137-3:2017/(R)2023
Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine control
01.01.2017 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI/ISO 11138-1:2017
Sterilization of health care products—Biological indicators—Part 1: General requirements
01.01.2017 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 11138-2:2017
Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes
01.01.2017 - PDF - Englisch - AAMI
mehr dazu123,00 € -
ANSI/AAMI/ISO 11138-3:2017
Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes
01.01.2017 - PDF - Englisch - AAMI
mehr dazu123,00 € -
ANSI/AAMI/ISO 11138-4:2017
Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes
01.01.2017 - PDF - Englisch - AAMI
mehr dazu123,00 € -
ANSI/AAMI/ISO 11138-5:2017
Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
01.01.2017 - PDF - Englisch - AAMI
mehr dazu123,00 € -
ANSI/AAMI/ISO 14708-3:2017
Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulators
01.01.2017 - PDF - Englisch - AAMI
mehr dazu245,00 € -
ANSI/AAMI/ISO 16142-2:2017
Medical devices—Recognized essential principles of safety and performance of medical devices—Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
01.01.2017 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 25539-1:2017
Cardiovascular implants— Endovascular devices—Part 1: Endovascular prostheses
01.01.2017 - PDF - Englisch - AAMI
mehr dazu215,00 € -
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
01.01.2017 - PDF - Englisch - AAMI
mehr dazu215,00 € -
141,00 € -
ANSI/AAMI/ISO 8637-1:2017
Extracorporeal systems for blood purification—Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
01.01.2017 - PDF - Englisch - AAMI
mehr dazu215,00 € -
ANSI/AAMI ST79:2017/(R)2022 w/ AMDs A1:2020, A2:2020, A3:2020, A4:2020
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
01.01.2017 - PDF - Englisch - AAMI
mehr dazu439,00 € -
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
01.01.2016 - PDF - Englisch - AAMI
mehr dazu215,00 € -
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
01.01.2016 - PDF - Englisch - AAMI
mehr dazu261,00 € -
AAMI/IEC TIR80002-3:2016
Medical Device Software—Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
01.01.2016 - PDF - Englisch - AAMI
mehr dazu215,00 € -
215,00 € -
ANSI/AAMI/ISO 10993-6:2016
Biological evaluation of medical devices—Part 6: Tests for local effects after implantation
01.01.2016 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI/ISO 13485:2016/(R)2019
Medical devices—Quality management systems—Requirements for regulatory purposes
01.01.2016 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 15674:2016
Cardiovascular implants and artificial organs—Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
01.01.2016 - PDF - Englisch - AAMI
mehr dazu123,00 € -
ANSI/AAMI/ISO 15675:2016
Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial blood line filters
01.01.2016 - PDF - Englisch - AAMI
mehr dazu123,00 € -
ANSI/AAMI/ISO 15676:2016
Cardiovascular implants and artificial organs—Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
01.01.2016 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI/ISO 16142-1:2016
Medical devices—Recognized essential principles of safety and performance of medical devices—Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
01.01.2016 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 18241:2016
Cardiovascular implants and extracorporeal systems—Cardiopulmonary bypass systems—Venous bubble traps
01.01.2016 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI/ISO 18242:2016
Cardiovascular implants and extracorporeal systems—Centrifugal blood pumps
01.01.2016 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI/ISO 22442-1:2016
Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management
01.01.2016 - PDF - Englisch - AAMI
mehr dazu215,00 € -
ANSI/AAMI/ISO 22442-2:2016
Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and handling
01.01.2016 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI/ISO 80369-3:2016
Small-bore connectors for liquids and gases in healthcare applications—Part 3: connectors for enteral applications
01.01.2016 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 80369-3:2016/A1:2019
Small-bore connectors for liquids and gases in healthcare applications—Part 3: Connectors for enteral applications—Amendment 1
01.01.2016 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI/ISO 80369-5:2016
Small-bore connectors for liquids and gases in healthcare applications—Part 5: Connectors for limb cuff inflation applications
01.01.2016 - PDF - Englisch - AAMI
mehr dazu215,00 € -
ANSI/AAMI/ISO 80369-6:2016
Small-bore connectors for liquids and gases in healthcare applications—Part 6: Connectors for neuraxial applications
01.01.2016 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 80369-7:2016
Small-bore connectors for liquids and gases in healthcare applications—Part 7: Connectors for intravascular or hypodermic applications
01.01.2016 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO TIR19024:2016
Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass
01.01.2016 - PDF - Englisch - AAMI
mehr dazu174,00 € -
261,00 € -
ANSI/AAMI/ISO 7199:2016
Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators)
01.01.2016 - PDF - Englisch - AAMI
mehr dazu141,00 € -
AAMI/IEC TIR62366-2:2016
Medical devices—Part 2: Guidance on the application of usability engineering to medical devices
01.01.2016 - PDF - Englisch - AAMI
mehr dazu303,00 € -
ANSI/AAMI/IEC 60601-1-12:2016
Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment & medical electrical systems intended for use in emergency medical services environ.
01.01.2016 - PDF - Englisch - AAMI
mehr dazu261,00 € -
141,00 € -
AAMI TIR28:2016/(R)2020
Product adoption and process equivalence for ethylene oxide sterilization
01.01.2016 - PDF - Englisch - AAMI
mehr dazu141,00 € -
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
01.01.2016 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI/IEC 60601-1-12:2016/A1:2021
Medical electrical equipment—Part 1-12: General requirements—Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services environment—Amendment 1
01.01.2016 - PDF - Englisch - AAMI
mehr dazu123,00 € -
ANSI/AAMI/IEC 60601-1-12:2016 & A1:2021 Redline
Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance— Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services envi
01.01.2016 - PDF - Englisch - AAMI
mehr dazu261,00 € -
AAMI TIR65:2015/(R)2022
Sustainability of medical devices—Elements of a responsible product life cycle
01.01.2015 - PDF - Englisch - AAMI
mehr dazu245,00 € -
AAMI/IEC TIR60878:2015
Graphic symbols for electrical equipment in medical practice
01.01.2015 - PDF - Englisch - AAMI
mehr dazu468,00 € -
ANSI/AAMI EQ89:2015/(R)2023
Guidance for the use of medical equipment maintenance strategies and procedures
01.01.2015 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI/ISO 80369-20:2015
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
01.01.2015 - PDF - Englisch - AAMI
mehr dazu245,00 € -
ANSI/AAMI/IEC TIR62354:2015
General testing procedures for medical electrical equipment
01.01.2015 - PDF - Englisch - AAMI
mehr dazu493,00 € -
ANSI/AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD)
MEDICAL ELECTRICAL EQUIPMENT—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
01.01.2015 - PDF - Englisch - AAMI
mehr dazu364,00 € -
ANSI/AAMI/IEC 62366-1:2015/(R)2021+AMD1:2020 (Consolidated Text)
Medical devices—Part 1: Application of usability engineering to medical devices + Amendment 1
01.01.2015 - PDF - Englisch - AAMI
mehr dazu261,00 € -
AAMI TIR48:2015/(R)2021
Quality Management System (QMS) Recommendations on the Application of the U.S. FDA—s CGMP Final Rule on Combination Products
01.01.2015 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI HA60601-1-11:2015/A1:2021
Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, Amendment 1
01.01.2015 - PDF - Englisch - AAMI
mehr dazu123,00 € -
ANSI/AAMI HA60601-1-11:2015 & A1:2021 Redline
Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance— Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
01.01.2015 - PDF - Englisch - AAMI
mehr dazu364,00 € -
AAMI TIR62:2014/(R)2019
Generating reports for the purpose of submitting defibrillation waveform data for evaluation
01.01.2014 - PDF - Englisch - AAMI
mehr dazu123,00 € -
AAMI TIR52:2014/(R)2022
Environmental monitoring for terminally sterilized healthcare products
01.01.2014 - PDF - Englisch - AAMI
mehr dazu123,00 € -
AAMI TIR55:2014/(R)2017
Human factors engineering for processing medical devices
01.01.2014 - PDF - Englisch - AAMI
mehr dazu174,00 € -
AAMI/IEC TIR80001-2-5:2014
Application of risk management for IT-networks incorporating medical devices—Part 2-5: Application guidance—Guidance for distributed alarm systems
01.01.2014 - PDF - Englisch - AAMI
mehr dazu215,00 € -
141,00 € -
AAMI TIR61:2014/(R)2019
Generating reports for human factors design validation results for external cardiac defibrillator
01.01.2014 - PDF - Englisch - AAMI
mehr dazu141,00 € -
AAMI/IEC TIR80001-2-7:2014
Application of risk management for IT-networks incorporating medical devices—Part 2-7: Application guidance—Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
01.01.2014 - PDF - Englisch - AAMI
mehr dazu303,00 € -
AAMI/ISO TIR17665-3:2014/(R)2016
Sterilization of health care products—Moist Heat—Guidance on the designation of a medical product to a product family and processing category for steam sterilization
01.01.2014 - PDF - Englisch - AAMI
mehr dazu261,00 € -
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 - AAMI
mehr dazu261,00 € -
ANSI/AAMI/IEC 80601-2-58:2014
Medical electrical equipment—Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery
01.01.2014 - PDF - Englisch - AAMI
mehr dazu174,00 € -
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
01.01.2014 - PDF - Englisch - AAMI
mehr dazu303,00 € -
ANSI/AAMI/ISO 11135:2014/A1:2018
Sterilization of health-care products— Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices—Amendment 1: Revision of Annex E, Single batch release
01.01.2014 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI/ISO 11140-1:2014
Sterilization of health care products—Chemical indicators—Part 1: General requirements
01.01.2014 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI/ISO 14708-1:2014
Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
01.01.2014 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO TIR37137:2014
Cardiovascular biological evaluation of medical devices—Guidance for absorbable implants
01.01.2014 - PDF - Englisch - AAMI
mehr dazu141,00 € -
215,00 € -
AAMI TIR51:2014/(R)2017
Human factors engineering—Guidance for contextual inquiry
01.01.2014 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI/IEC 60601-1-2:2014
Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests
01.01.2014 - PDF - Englisch - AAMI
mehr dazu364,00 € -
AAMI/ISO TIR80001-2-6:2014
Application of risk management for IT-networks incorporating medical—Application guidance—Part 2-6: Guidance for responsibility agreements
01.01.2014 - PDF - Englisch - AAMI
mehr dazu141,00 € -
AAMI TIR63:2014/(R)2023
Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
01.01.2014 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI/IEC 60601-1-2:2014/A1:2021
Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests, Amendment 1
01.01.2014 - PDF - Englisch - AAMI
mehr dazu245,00 € -
ANSI/AAMI/IEC 60601-1-2:2014 & A1:2021 Redline
Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests Consolidated Text, Redline Version
01.01.2014 - PDF - Englisch - AAMI
mehr dazu303,00 € -
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.
01.01.2013 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI ST58:2013/(R)2018
Chemical sterilization and high-level disinfection in health care facilities
01.01.2013 - PDF - Englisch - AAMI
mehr dazu303,00 € -
ANSI/AAMI ST77:2013/(R)2018
Containment devices for reusable medical device sterilization
01.01.2013 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI/ISO 11137-2:2013/(R)2019
Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose
01.01.2013 - PDF - Englisch - AAMI
mehr dazu261,00 € -
215,00 € -
AAMI TIR49:2013/(R)2020
Design of training and instructional materials for medical devices used in non-clinical environments
01.01.2013 - PDF - Englisch - AAMI
mehr dazu245,00 € -
ANSI/AAMI EQ56:2013
Recommended practice for a medical equipment management program
01.01.2013 - PDF - Englisch - AAMI
mehr dazu215,00 € -
AAMI TIR56:2013/(R)2020
Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
01.01.2013 - PDF - Englisch - AAMI
mehr dazu174,00 € -
141,00 € -
AAMI TIR44:2012
Non-invasive blood pressure motion artifact—Testing and evaluation of NIBP device performance in the presence of motion artifact
01.01.2012 - PDF - Englisch - AAMI
mehr dazu174,00 € -
AAMI/IEC TIR80001-2-3:2012
Application of risk management for IT-networks incorporating medical devices—Part 2-3: Guidance for wireless networks
01.01.2012 - PDF - Englisch - AAMI
mehr dazu245,00 € -
AAMI/IEC TIR80001-2-4:2012
Application of risk management for IT-networks incorporating medical devices—Part 2-4: General implementation guidance for healthcare delivery organizations.
01.01.2012 - PDF - Englisch - AAMI
mehr dazu174,00 € -
AAMI/ISO TIR23810:2012/(R)2015
Cardiovascular implants and artificial organs—Checklist for preoperative extracorporeal circulation equipment setup
01.01.2012 - PDF - Englisch - AAMI
mehr dazu215,00 € -
ANSI/AAMI PB70:2012 Red-Line
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
01.01.2012 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI ST15883-3:2012/(R)2023
Washer-disinfectors—Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
01.01.2012 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI/ISO 10993-12:2012
Biological evaluation of medical devices—Part 12: Sample preparation and reference materials
01.01.2012 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI/IEC 60601-2-47:2012/(R)2016
Medical electrical equipment—Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
01.01.2012 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/IEC TIR80001-2-1:2012
Application of risk management for IT-networks incorporating medical devices—Part 2-1: Step by step risk management of medical IT-networks, Practical applications and examples.
01.01.2012 - PDF - Englisch - AAMI
mehr dazu261,00 €
