AAMI
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AAMI/ISO TI (R1677)5:2023
Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2
18/08/2023 - PDF - Anglais - AAMI
En savoir plus396,00 € -
AAMI TIR34971:2023
Application of ISO 14971 to machine learning in artificial intelligence—Guide
14/03/2023 - PDF - Anglais - AAMI
En savoir plus233,00 € -
AAMI/ISO 15223-1:2022
Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
09/01/2023 - PDF - Anglais - AAMI
En savoir plus266,00 € -
ANSI/AAMI/ISO 10993-13-2010/(R)2014:2023
Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices
01/01/2023 - PDF - Anglais - AAMI
En savoir plus119,00 € -
ANSI/AAMI SW96:2023
Standard for medical device security—Security risk management for device manufacturers
01/01/2023 - PDF - Anglais - AAMI
En savoir plus253,00 € -
AAMI TIR34971:2023
Application of ISO 14971 to machine learning in artificial intelligence—Guide
01/01/2023 - PDF - Anglais - AAMI
En savoir plus207,00 € -
AAMI TIR45:2023
Guidance on the use of AGILE practices in the development of medical device software
01/01/2023 - PDF - Anglais - AAMI
En savoir plus293,00 € -
AAMI TIR45:2023 Redline
Guidance on the use of AGILE practices in the development of medical device software
01/01/2023 - PDF - Anglais - AAMI
En savoir plus293,00 € -
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 - Anglais - AAMI
En savoir plus136,00 € -
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 - Anglais - AAMI
En savoir plus352,00 € -
293,00 € -
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 - Anglais - AAMI
En savoir plus168,00 € -
AAMI/ISO TI (R2245)6: 2022
Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
27/12/2022 - PDF - Anglais - AAMI
En savoir plus189,00 € -
AAMI/ISO 17664-1:2022
Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices
21/12/2022 - PDF - Anglais - AAMI
En savoir plus233,00 € -
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
21/12/2022 - PDF - Anglais - AAMI
En savoir plus233,00 € -
AAMI/ISO TIR 11137-4:2022
Sterilization of health care products-Radiation-Part 4: Guidance on process control
12/06/2022 - PDF - Anglais - AAMI
En savoir plus276,00 € -
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 - Anglais - AAMI
En savoir plus237,00 € -
AAMI TIR104:2022
Guidance on transferring health care products between radiation sterilization sources
01/01/2022 - PDF - Anglais - AAMI
En savoir plus207,00 € -
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 - Anglais - AAMI
En savoir plus237,00 € -
ANSI/AAMI/UL 2800-1-1:2022
Standard for Risk Concerns for Interoperable Medical Products
01/01/2022 - PDF - Anglais - AAMI
En savoir plus253,00 € -
ANSI/AAMI/UL 2800-1-2:2022
Standard for Interoperable Item Development Life Cycle
01/01/2022 - PDF - Anglais - AAMI
En savoir plus237,00 € -
ANSI/AAMI/UL 2800-1-3:2022
Standard for Interoperable Item Integration Life Cycle
01/01/2022 - PDF - Anglais - AAMI
En savoir plus207,00 € -
293,00 € -
ANSI/AAMI/ISO 18472:2022
Sterilization of health care products—Biological and chemical indicators—Test equipment
01/01/2022 - PDF - Anglais - AAMI
En savoir plus237,00 € -
ANSI/AAMI/ISO 5840-1:2022
Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements
01/01/2022 - PDF - Anglais - AAMI
En savoir plus293,00 € -
ANSI/AAMI/ISO 5840-2:2022
Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes
01/01/2022 - PDF - Anglais - AAMI
En savoir plus253,00 € -
ANSI/AAMI/ISO 5840-3:2022
Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques
01/01/2022 - PDF - Anglais - AAMI
En savoir plus253,00 € -
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 - Anglais - AAMI
En savoir plus237,00 € -
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 - Anglais - AAMI
En savoir plus168,00 € -
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 - Anglais - AAMI
En savoir plus253,00 € -
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 - Anglais - AAMI
En savoir plus207,00 € -
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 - Anglais - AAMI
En savoir plus207,00 € -
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 - Anglais - AAMI
En savoir plus237,00 € -
AAMI/ISO TIR11137-4:2022
Sterilization of health care products—Radiation—Part 4: Guidance on process control
01/01/2022 - PDF - Anglais - AAMI
En savoir plus253,00 € -
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 - Anglais - AAMI
En savoir plus253,00 € -
251,00 €
-
AAMI/ISO 5840-3:2022
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
13/12/2021 - PDF - Anglais - AAMI
En savoir plus285,00 € -
AAMI/ISO 5840-2:2022
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
13/12/2021 - PDF - Anglais - AAMI
En savoir plus285,00 € -
AAMI/ISO 18472:2022
Sterilization of health care products - Biological and chemical indicators - Test equipment
13/12/2021 - PDF - Anglais - AAMI
En savoir plus266,00 € -
AAMI/ISO 5840-1:2022
Cardiovascular implants - Cardiac valve prostheses - Part 1: General Requirements
13/12/2021 - PDF - Anglais - AAMI
En savoir plus330,00 € -
AAMI/ISO CN27:2021
General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
06/12/2021 - PDF - Anglais - AAMI
En savoir plus220,00 € -
AAMI CR510:2021
Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
01/01/2021 - PDF - Anglais - AAMI
En savoir plus119,00 € -
AAMI TIR101:2021
Fluid delivery performance testing for infusion pumps
01/01/2021 - PDF - Anglais - AAMI
En savoir plus253,00 € -
ANSI/AAMI CN27:2021
General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
01/01/2021 - PDF - Anglais - AAMI
En savoir plus207,00 € -
237,00 € -
ANSI/AAMI ST91:2021
Flexible and semi-rigid endoscope processing in health care facilities
01/01/2021 - PDF - Anglais - AAMI
En savoir plus341,00 € -
AAMI TIR42:2021
Evaluation of particulate associated with vascular medical devices
01/01/2021 - PDF - Anglais - AAMI
En savoir plus237,00 € -
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 - Anglais - AAMI
En savoir plus293,00 € -
AAMI TIR43:2021
Ultrapure dialysis fluid for hemodialysis and related therapies
01/01/2021 - PDF - Anglais - AAMI
En savoir plus237,00 € -
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 - Anglais - AAMI
En savoir plus237,00 € -
AAMI TIR100:2021
End-to-end microbiological quality and sterility assurance
01/01/2021 - PDF - Anglais - AAMI
En savoir plus168,00 € -
AAMI/ISO 14155:2020
Clinical investigation of medical devices for human subjects - Good clinical practice
07/12/2020 - PDF - Anglais - AAMI
En savoir plus310,00 € -
AAMI/ISO 10993-16:2017
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
06/11/2020 - PDF - Anglais - AAMI
En savoir plus144,00 € -
AAMI/ISO 10993-15:2019
Biological evaluation of medical devices?Part 15: Identification and quantification of degradation products from metals and alloys
05/10/2020 - PDF - Anglais - AAMI
En savoir plus144,00 € -
AAMI/ISO 8637-1:2017
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
01/07/2020 - PDF - Anglais - AAMI
En savoir plus220,00 € -
AAMI/ISO 8637-3:2018
Extracorporeal systems for blood purification - Part 3: Plasmafilters
01/07/2020 - PDF - Anglais - AAMI
En savoir plus179,00 € -
AAMI/ISO 8637-2:2018
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
01/07/2020 - PDF - Anglais - AAMI
En savoir plus179,00 € -
AAMI/ISO 10993-4:2017
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
27/04/2020 - PDF - Anglais - AAMI
En savoir plus268,00 € -
AAMI/ISO 10993-1:2018
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
27/04/2020 - PDF - Anglais - AAMI
En savoir plus268,00 € -
AAMI/ISO 10993-11:2017
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
27/04/2020 - PDF - Anglais - AAMI
En savoir plus220,00 € -
AAMI/ISO TI (R2041)6:2020
Medical devices - Post-market surveillance for manufacturers
16/02/2020 - PDF - Anglais - AAMI
En savoir plus260,00 € -
AAMI/ISO TI (R2497)1:2020
Medical devices - Guidance on the application of ISO 14971
02/02/2020 - PDF - Anglais - AAMI
En savoir plus310,00 € -
AAMI/ISO TIR20416:2020
Medical devices—Post-market surveillance for manufacturers
01/01/2020 - PDF - Anglais - AAMI
En savoir plus237,00 € -
AAMI/ISO TIR24971:2020
Medical devices—Guidance on the application of ISO 14971
01/01/2020 - PDF - Anglais - AAMI
En savoir plus293,00 € -
253,00 € -
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 - Anglais - AAMI
En savoir plus237,00 € -
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 - Anglais - AAMI
En savoir plus20,00 € -
237,00 € -
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 - Anglais - AAMI
En savoir plus253,00 € -
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 - Anglais - AAMI
En savoir plus253,00 € -
AAMI TIR12:2020
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
01/01/2020 - PDF - Anglais - AAMI
En savoir plus253,00 € -
ANSI/AAMI/ISO 14155:2020
Clinical investigation of medical devices for human subjects—Good clinical practice
01/01/2020 - PDF - Anglais - AAMI
En savoir plus293,00 € -
AAMI/ISO 80369-1:2018
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
30/12/2019 - PDF - Anglais - AAMI
En savoir plus140,00 € -
AAMI/ISO 23500-1:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements
23/12/2019 - PDF - Anglais - AAMI
En savoir plus310,00 € -
AAMI/ISO 23500-3:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
23/12/2019 - PDF - Anglais - AAMI
En savoir plus179,00 € -
AAMI/ISO 23500-5:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
23/12/2019 - PDF - Anglais - AAMI
En savoir plus179,00 € -
AAMI/ISO 23500-4:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
23/12/2019 - PDF - Anglais - AAMI
En savoir plus220,00 € -
AAMI/ISO 23500-2:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
23/12/2019 - PDF - Anglais - AAMI
En savoir plus251,00 € -
AAMI/ISO 11138-7:2019
Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results
01/11/2019 - PDF - Anglais - AAMI
En savoir plus268,00 € -
AAMI 14117:2019
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
27/09/2019 - PDF - Anglais - AAMI
En savoir plus310,00 € -
AAMI/ISO 11737-2: 2019
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
11/07/2019 - PDF - Anglais - AAMI
En savoir plus179,00 € -
AAMI/ISO 14971:2019
Medical devices - Application of risk management to medical devices
01/05/2019 - PDF - Anglais - AAMI
En savoir plus268,00 € -
AAMI/ISO 81060-2:2019
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
22/03/2019 - PDF - Anglais - AAMI
En savoir plus251,00 € -
AAMI TIR97:2019/(R)2023
Principles for medical device security—Postmarket risk management for device manufacturers
01/01/2019 - PDF - Anglais - AAMI
En savoir plus253,00 € -
AAMI HIT1000-3(PS):2019
Safety and effectiveness of health IT software and systems—Part 3: Application of risk management
01/01/2019 - PDF - Anglais - AAMI
En savoir plus20,00 € -
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 - Anglais - AAMI
En savoir plus293,00 € -
253,00 € -
AAMI TIR75:2019
Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
01/01/2019 - PDF - Anglais - AAMI
En savoir plus207,00 € -
ANSI/AAMI EQ93:2019
Medical equipment management—Vocabulary used in medical equipment programs
01/01/2019 - PDF - Anglais - AAMI
En savoir plus119,00 € -
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 - Anglais - AAMI
En savoir plus207,00 € -
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 - Anglais - AAMI
En savoir plus136,00 € -
ANSI/AAMI ST72:2019
Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing
01/01/2019 - PDF - Anglais - AAMI
En savoir plus253,00 € -
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 - Anglais - AAMI
En savoir plus253,00 € -
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 - Anglais - AAMI
En savoir plus293,00 € -
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 - Anglais - AAMI
En savoir plus168,00 € -
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 - Anglais - AAMI
En savoir plus136,00 € -
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 - Anglais - AAMI
En savoir plus168,00 € -
ANSI/AAMI/ISO 14971:2019
Medical devices—Application of risk management to medical devices
01/01/2019 - PDF - Anglais - AAMI
En savoir plus253,00 € -
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 - Anglais - AAMI
En savoir plus293,00 € -
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 - Anglais - AAMI
En savoir plus237,00 € -
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 - Anglais - AAMI
En savoir plus168,00 € -
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 - Anglais - AAMI
En savoir plus207,00 € -
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 - Anglais - AAMI
En savoir plus168,00 € -
ANSI/AAMI/ISO 81060-2:2019
Non-invasive sphygmomanometers—Clinical investigation of intermittent automated measurement type
01/01/2019 - PDF - Anglais - AAMI
En savoir plus237,00 € -
168,00 € -
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 - Anglais - AAMI
En savoir plus136,00 € -
AAMI/ISO 11607-1: 2019
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
01/01/2019 - PDF - Anglais - AAMI
En savoir plus179,00 € -
AAMI/ISO 11607-2: 2019
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
01/01/2019 - PDF - Anglais - AAMI
En savoir plus144,00 € -
AAMI/ISO TI (R2190)0:2018
Guidance for uncertainty analysis regarding the application of ISO/TS 10974
19/07/2018 - PDF - Anglais - AAMI
En savoir plus144,00 € -
AAMI/ISO TI (R1097)4:2018
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
01/05/2018 - PDF - Anglais - AAMI
En savoir plus333,00 € -
AAMI TIR40:2018 (R2022)
Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
31/01/2018 - PDF - Anglais - AAMI
En savoir plus189,00 € -
AAMI/ISO 11737-1:2018
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
24/01/2018 - PDF - Anglais - AAMI
En savoir plus190,00 € -
AAMI TIR40:2018/(R)2022
Sterilization of health care products—Radiation—Guidance on dose setting utilizing a Modified Method 2
01/01/2018 - PDF - Anglais - AAMI
En savoir plus168,00 € -
168,00 € -
AAMI/ISO TIR10974:2018
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
01/01/2018 - PDF - Anglais - AAMI
En savoir plus314,00 € -
AAMI/ISO TIR21900:2018
Guidance for uncertainty analysis regarding the application of ISO/TS 10974
01/01/2018 - PDF - Anglais - AAMI
En savoir plus136,00 € -
253,00 € -
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 - Anglais - AAMI
En savoir plus253,00 € -
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 - Anglais - AAMI
En savoir plus253,00 € -
ANSI/AAMI/ISO 13408-2:2018
Aseptic processing of health care products—Part 2: Sterilizing filtration
01/01/2018 - PDF - Anglais - AAMI
En savoir plus136,00 € -
ANSI/AAMI/ISO 80369-1:2018
Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements
01/01/2018 - PDF - Anglais - AAMI
En savoir plus136,00 € -
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 - Anglais - AAMI
En savoir plus253,00 € -
ANSI/AAMI/ISO 8637-3:2018
Extracorporeal systems for blood purification—Part 3: Plasmafilters
01/01/2018 - PDF - Anglais - AAMI
En savoir plus168,00 € -
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 - Anglais - AAMI
En savoir plus168,00 € -
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 - Anglais - AAMI
En savoir plus253,00 € -
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 - Anglais - AAMI
En savoir plus207,00 € -
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 - Anglais - AAMI
En savoir plus253,00 € -
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 - Anglais - AAMI
En savoir plus207,00 € -
AAMI TIR16:2017 (R2020)
Microbiological aspects of ethylene oxide sterilization
17/11/2017 - PDF - Anglais - AAMI
En savoir plus179,00 € -
AAMI/ISO 13408-2:2018
Aseptic processing of health care products - Part 2:Sterilizing filtration
17/11/2017 - PDF - Anglais - AAMI
En savoir plus144,00 € -
AAMI/ISO 11137-3:2017 (R2023)
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine
06/10/2017 - PDF - Anglais - AAMI
En savoir plus153,00 € -
AAMI/ISO 80369-7:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
27/09/2017 - PDF - Anglais - AAMI
En savoir plus268,00 € -
AAMI/ISO TI (R1549)9:2017
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
27/08/2017 - PDF - Anglais - AAMI
En savoir plus173,00 € -
AAMI/ISO TIR80002-2:2017
Medical device software - Part 2: Validation of software for medical device quality systems
18/08/2017 - PDF - Anglais, Français - AAMI
En savoir plus310,00 € -
AAMI/ISO 11138-1:2017
Sterilization of health care products - Biological indicators - Part 1: General requirements
01/08/2017 - PDF - Anglais - AAMI
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AAMI/ISO 11138-5:2017
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
01/08/2017 - PDF - Anglais - AAMI
En savoir plus125,00 € -
AAMI/ISO 11138-2:2017
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
01/08/2017 - PDF - Anglais - AAMI
En savoir plus125,00 € -
AAMI/ISO 11138-4:2017
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
01/08/2017 - PDF - Anglais - AAMI
En savoir plus125,00 € -
AAMI/ISO 11138-3:2017
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
01/08/2017 - PDF - Anglais - AAMI
En savoir plus125,00 € -
AAMI/ISO 16142-2:2017
Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
31/07/2017 - PDF - Anglais - AAMI
En savoir plus268,00 € -
AAMI/ISO 25539-1:2017
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
25/05/2017 - PDF - Anglais - AAMI
En savoir plus220,00 € -
AAMI/ISO 14708-3:2017
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
02/03/2017 - PDF - Anglais - AAMI
En savoir plus251,00 € -
AAMI/ISO 10993-6:2016
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
10/01/2017 - PDF - Anglais - AAMI
En savoir plus179,00 € -
AAMI TIR21:2017/(R)2020
Systems used to forecast remaining pacemaker battery service life
01/01/2017 - PDF - Anglais - AAMI
En savoir plus253,00 € -
AAMI TIR69:2017/(R)2020
Risk management of radio-frequency wireless coexistence for medical devices and systems
01/01/2017 - PDF - Anglais - AAMI
En savoir plus253,00 € -
136,00 € -
ANSI/AAMI CI86:2017
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
01/01/2017 - PDF - Anglais - AAMI
En savoir plus293,00 € -
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 - Anglais - AAMI
En savoir plus168,00 € -
AAMI/ISO TIR80002-2:2017
Medical device software—Part 2: Validation of software for medical device quality systems
01/01/2017 - PDF - Anglais - AAMI
En savoir plus293,00 € -
ANSI/AAMI ST90:2017
Processing of health care products—Quality management systems for processing in health care facilities
01/01/2017 - PDF - Anglais - AAMI
En savoir plus237,00 € -
ANSI/AAMI/ISO 10993-11:2017/(R)2023
Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
01/01/2017 - PDF - Anglais - AAMI
En savoir plus207,00 € -
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 - Anglais - AAMI
En savoir plus253,00 € -
ANSI/AAMI/ISO 10993-4:2017
Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
01/01/2017 - PDF - Anglais - AAMI
En savoir plus253,00 € -
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 - Anglais - AAMI
En savoir plus136,00 € -
ANSI/AAMI/ISO 11138-1:2017
Sterilization of health care products—Biological indicators—Part 1: General requirements
01/01/2017 - PDF - Anglais - AAMI
En savoir plus253,00 € -
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 - Anglais - AAMI
En savoir plus119,00 € -
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 - Anglais - AAMI
En savoir plus119,00 € -
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 - Anglais - AAMI
En savoir plus119,00 € -
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 - Anglais - AAMI
En savoir plus119,00 € -
ANSI/AAMI/ISO 14708-3:2017
Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulators
01/01/2017 - PDF - Anglais - AAMI
En savoir plus237,00 € -
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 - Anglais - AAMI
En savoir plus253,00 € -
ANSI/AAMI/ISO 25539-1:2017
Cardiovascular implants— Endovascular devices—Part 1: Endovascular prostheses
01/01/2017 - PDF - Anglais - AAMI
En savoir plus207,00 € -
207,00 € -
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 - Anglais - AAMI
En savoir plus207,00 € -
136,00 € -
ANSI/AAMI/ISO 8637-1:2017
Extracorporeal systems for blood purification—Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
01/01/2017 - PDF - Anglais - AAMI
En savoir plus207,00 € -
AAMI TIR16:2017/(R)2020
Microbiological aspects of ethylene oxide sterilization
01/01/2017 - PDF - Anglais - AAMI
En savoir plus168,00 € -
ANSI/AAMI/ISO 10993-16:2017
Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
01/01/2017 - PDF - Anglais - AAMI
En savoir plus136,00 € -
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 - Anglais - AAMI
En savoir plus424,00 € -
AAMI TIR17:2017/(R)2020
Compatibility of materials subject to sterilization
01/01/2017 - PDF - Anglais - AAMI
En savoir plus293,00 € -
179,00 €
-
AAMI/ISO 7199:2016
Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
18/11/2016 - PDF - Anglais - AAMI
En savoir plus144,00 € -
AAMI/ISO 15676:2016
Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
18/11/2016 - PDF - Anglais - AAMI
En savoir plus144,00 € -
AAMI/ISO 15675:2016
Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
18/11/2016 - PDF - Anglais - AAMI
En savoir plus125,00 € -
AAMI/ISO 18242:2016
Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
18/11/2016 - PDF - Anglais - AAMI
En savoir plus144,00 € -
AAMI TIR28:2016 (R2020)
Product adoption and process equivalency for ethylene oxide sterilization
18/11/2016 - PDF - Anglais - AAMI
En savoir plus144,00 € -
AAMI/ISO 22442-1:2016
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
17/11/2016 - PDF - Anglais - AAMI
En savoir plus190,00 € -
AAMI/ISO 22442-2:2016
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
17/11/2016 - PDF - Anglais - AAMI
En savoir plus144,00 € -
AAMI/ISO 15674:2016
Cardiovascular implants and artificial organs - Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
16/11/2016 - PDF - Anglais - AAMI
En savoir plus125,00 € -
AAMI/ISO 18241:2016
Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
07/11/2016 - PDF - Anglais - AAMI
En savoir plus179,00 € -
AAMI/ISO TI (R1902)4:2016
Evaluation of CPB devices relative to their capabilities of reducing the transmition of gaseous microemboli (GME) to a patient during cardiopulmonary bypass
09/10/2016 - PDF - Anglais - AAMI
En savoir plus179,00 € -
AAMI/ISO 16142-1:2016
Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
10/08/2016 - PDF - Anglais - AAMI
En savoir plus268,00 € -
AAMI/ISO 80369-6:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
04/08/2016 - PDF - Anglais - AAMI
En savoir plus268,00 € -
AAMI/ISO 80369-5:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
04/08/2016 - PDF - Anglais - AAMI
En savoir plus220,00 € -
AAMI/ISO 7198:2016
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
02/08/2016 - PDF - Anglais - AAMI
En savoir plus268,00 € -
144,00 €
-
AAMI/ISO 80369-3:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
05/06/2016 - PDF - Anglais - AAMI
En savoir plus268,00 € -
AAMI/ISO 13485:2016 (R2019)
Medical devices - Quality management systems - Requirements for regulatory purposes
25/03/2016 - PDF - Anglais - AAMI
En savoir plus268,00 € -
Checklist for ISO 13485:2016, Medical Devices - Quality Management Systems- Requ
Software Engineering Process Technology, 03/01/2016
01/03/2016 - PDF - Anglais - AAMI
En savoir plus353,00 € -
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 - Anglais - AAMI
En savoir plus207,00 € -
AAMI TIR57:2016/(R)2023
Principles for medical device security—Risk management
01/01/2016 - PDF - Anglais - AAMI
En savoir plus293,00 € -
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 - Anglais - AAMI
En savoir plus253,00 € -
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 - Anglais - AAMI
En savoir plus207,00 € -
207,00 € -
ANSI/AAMI/ISO 10993-6:2016
Biological evaluation of medical devices—Part 6: Tests for local effects after implantation
01/01/2016 - PDF - Anglais - AAMI
En savoir plus168,00 € -
ANSI/AAMI/ISO 13485:2016/(R)2019
Medical devices—Quality management systems—Requirements for regulatory purposes
01/01/2016 - PDF - Anglais - AAMI
En savoir plus253,00 € -
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 - Anglais - AAMI
En savoir plus119,00 € -
ANSI/AAMI/ISO 15675:2016
Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial blood line filters
01/01/2016 - PDF - Anglais - AAMI
En savoir plus119,00 € -
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 - Anglais - AAMI
En savoir plus136,00 € -
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 - Anglais - AAMI
En savoir plus253,00 €
