AAMI
-
€39.52 -
€294.32
-
€249.08
-
Medical Devices - A Practical Guide, Advice from ISO/TC 210 (13485:2016)
Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
1/22/2020 - Paper - English - AAMI
Learn More€197.60 -
Medical Devices - A Practical Guide, Advice from ISO/TC 210 (13485:2016)
Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
1/22/2020 - PDF - English - AAMI
Learn More€137.35 -
AAMI/ISO 80369-1:2018
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
12/30/2019 - Paper - English - AAMI
Learn More€163.28 -
AAMI/ISO 80369-1:2018
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
12/30/2019 - PDF - English - AAMI
Learn More€134.28 -
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
12/23/2019 - Paper - English - AAMI
Learn More€264.16 -
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
12/23/2019 - PDF - English - AAMI
Learn More€233.70 -
AAMI/ISO 23500-4:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
12/23/2019 - Paper - English - AAMI
Learn More€235.04 -
AAMI/ISO 23500-4:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
12/23/2019 - PDF - English - AAMI
Learn More€205.00 -
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
12/23/2019 - Paper - English - AAMI
Learn More€195.52 -
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
12/23/2019 - PDF - English - AAMI
Learn More€166.05 -
AAMI/ISO 23500-3:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
12/23/2019 - Paper - English - AAMI
Learn More€195.52 -
AAMI/ISO 23500-3:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
12/23/2019 - PDF - English - AAMI
Learn More€166.05 -
AAMI/ISO 23500-1:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements
12/23/2019 - Paper - English - AAMI
Learn More€334.88 -
AAMI/ISO 23500-1:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements
12/23/2019 - PDF - English - AAMI
Learn More€289.05 -
€195.52
-
€166.05
-
AAMI/ISO 11138-7:2019
Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results
11/1/2019 - Paper - English - AAMI
Learn More€294.32 -
AAMI/ISO 11138-7:2019
Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results
11/1/2019 - PDF - English - AAMI
Learn More€249.08 -
AAMI ST72:2019
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
11/1/2019 - Paper - English - AAMI
Learn More€294.32 -
AAMI ST72:2019
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
11/1/2019 - PDF - English - AAMI
Learn More€249.08 -
AAMI TIR97:2019
Principles for medical device security - Postmarket risk management for device manufacturers
9/27/2019 - Paper - English - AAMI
Learn More€294.32 -
AAMI TIR97:2019
Principles for medical device security - Postmarket risk management for device manufacturers
9/27/2019 - PDF - English - AAMI
Learn More€249.08 -
AAMI/ISO 14117:2019
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
9/27/2019 - Paper - English - AAMI
Learn More€351.52 -
AAMI/ISO 14117:2019
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
9/27/2019 - PDF - English - AAMI
Learn More€289.05 -
AAMI TIR102:2019
U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
8/30/2019 - Paper - English - AAMI
Learn More€351.52 -
AAMI TIR102:2019
U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
8/30/2019 - PDF - English - AAMI
Learn More€289.05 -
AAMI ST67:2019
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled 'sterile'
7/29/2019 - Paper - English - AAMI
Learn More€163.28 -
AAMI ST67:2019
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled 'sterile'
7/29/2019 - PDF - English - AAMI
Learn More€134.28 -
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
7/11/2019 - Paper - English - AAMI
Learn More€195.52 -
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
7/11/2019 - PDF - English - AAMI
Learn More€166.05 -
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
7/1/2019 - Paper - English - AAMI
Learn More€235.04 -
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
7/1/2019 - PDF - English - AAMI
Learn More€205.00 -
AAMI TIR75:2019
Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
6/1/2019 - Paper - English - AAMI
Learn More€235.04 -
AAMI TIR75:2019
Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
6/1/2019 - PDF - English - AAMI
Learn More€205.00 -
AAMI/ISO 14971:2019
Medical devices - Application of risk management to medical devices
5/1/2019 - Paper - English - AAMI
Learn More€279.76 -
AAMI/ISO 14971:2019
Medical devices - Application of risk management to medical devices
5/1/2019 - PDF - English - AAMI
Learn More€249.08 -
AAMI EQ93:2019
Medical equipment management - Vocabulary used in medical equipment programs
4/18/2019 - Paper - English - AAMI
Learn More€145.60 -
AAMI EQ93:2019
Medical equipment management - Vocabulary used in medical equipment programs
4/18/2019 - PDF - English - AAMI
Learn More€116.85 -
AAMI/ISO 81060-2:2019
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
3/22/2019 - Paper - English - AAMI
Learn More€264.16 -
AAMI/ISO 81060-2:2019
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
3/22/2019 - PDF - English - AAMI
Learn More€233.70 -
AAMI 2800-1:2019
Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2019)
2/25/2019 - Paper - English - AAMI
Learn More€488.80 -
AAMI 2800-1:2019
Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2019)
2/25/2019 - PDF - English - AAMI
Learn More€424.35 -
€294.32
-
€249.08
-
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 - Paper - English - AAMI
Learn More€210.08 -
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
Learn More€166.05 -
AAMI/ISO 11607-2: 2019
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
1/1/2019 - Paper - English - AAMI
Learn More€163.28 -
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
Learn More€134.28 -
€294.32
-
€249.08
-
AAMI TIR68:2018
Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
9/30/2018 - Paper - English - AAMI
Learn More€195.52 -
AAMI/ISO TI(R2190)0:2018
Guidance for uncertainty analysis regarding the application of ISO/TS 10974
7/19/2018 - Paper - English - AAMI
Learn More€163.28 -
AAMI/ISO TI(R2190)0:2018
Guidance for uncertainty analysis regarding the application of ISO/TS 10974
7/19/2018 - PDF - English - AAMI
Learn More€134.28 -
AAMI TIR77:2018
Technical Information Report Sorbent-based regenerative hemodialysis systems
6/8/2018 - Paper - English - AAMI
Learn More€195.52 -
AAMI TIR77:2018
Technical Information Report Sorbent-based regenerative hemodialysis systems
6/8/2018 - PDF - English - AAMI
Learn More€166.05 -
AAMI/ISO TI(R1097)4:2018
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
5/1/2018 - Paper - English - AAMI
Learn More€372.32 -
AAMI/ISO TI(R1097)4:2018
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
5/1/2018 - PDF - English - AAMI
Learn More€309.55 -
AAMI TIR67:2018
Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
4/25/2018 - Paper - English - AAMI
Learn More€294.32 -
AAMI TIR67:2018
Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
4/25/2018 - PDF - English - AAMI
Learn More€249.08 -
AAMI TIR40:2018
Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
1/31/2018 - Paper - English - AAMI
Learn More€195.52 -
AAMI TIR40:2018
Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
1/31/2018 - PDF - English - AAMI
Learn More€166.05 -
AAMI/ISO 11737-1:2018
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
1/24/2018 - Paper - English - AAMI
Learn More€221.52 -
AAMI/ISO 11737-1:2018
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
1/24/2018 - PDF - English - AAMI
Learn More€177.33 -
AAMI/ISO 11737-1:2018
AAMI/ISO CDV-3 11737-1, Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product
1/1/2018 - PDF sécurisé - English - AAMI
Learn More€154.56 -
ANSI/AAMI/IEC 80601-2-30:2018
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
1/1/2018 - PDF sécurisé - English - AAMI
Learn More€228.42 -
AAMI/ISO 13408-2:2018
Aseptic processing of health care products - Part 2: Sterilizing filtration
1/1/2018 - PDF sécurisé - English - AAMI
Learn More€113.16 -
AAMI/ISO 13408-2:2018
Aseptic processing of health care products - Part 2:Sterilizing filtration
11/17/2017 - Paper - English - AAMI
Learn More€163.28 -
AAMI/ISO 13408-2:2018
Aseptic processing of health care products - Part 2:Sterilizing filtration
11/17/2017 - PDF - English - AAMI
Learn More€134.28 -
€195.52
-
€166.05
-
AAMI/ISO 11137-3:2017
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine
10/6/2017 - Paper - English - AAMI
Learn More€163.28 -
AAMI/ISO 11137-3:2017
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine
10/6/2017 - PDF - English - AAMI
Learn More€134.28 -
AAMI ST79:2017
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
10/1/2017 - Paper - English - AAMI
Learn More€482.56 -
AAMI ST79:2017
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
10/1/2017 - PDF - English - AAMI
Learn More€418.20 -
AAMI/ISO 80369-7:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
9/27/2017 - Paper - English - AAMI
Learn More€294.32 -
AAMI/ISO 80369-7:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
9/27/2017 - PDF - English - AAMI
Learn More€249.08 -
€163.28
-
€134.28
-
AAMI/ISO TI(R1549)9:2017
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
8/27/2017 - Paper - English - AAMI
Learn More€190.32 -
AAMI/ISO TI(R1549)9:2017
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
8/27/2017 - PDF - English - AAMI
Learn More€160.93 -
AAMI/ISO 17664:2017
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
8/18/2017 - Paper - English - AAMI
Learn More€235.04 -
AAMI/ISO 17664:2017
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
8/18/2017 - PDF - English - AAMI
Learn More€205.00 -
€163.28
-
€134.28
-
€235.04
-
€205.00
-
AAMI/ISO 11138-4:2017
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
8/1/2017 - Paper - English - AAMI
Learn More€145.60 -
AAMI/ISO 11138-4:2017
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
8/1/2017 - PDF - English - AAMI
Learn More€116.85 -
AAMI/ISO 11138-3:2017
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
8/1/2017 - Paper - English - AAMI
Learn More€145.60 -
AAMI/ISO 11138-3:2017
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
8/1/2017 - PDF - English - AAMI
Learn More€116.85 -
AAMI/ISO 11138-2:2017
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
8/1/2017 - Paper - English - AAMI
Learn More€145.60 -
AAMI/ISO 11138-2:2017
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
8/1/2017 - PDF - English - AAMI
Learn More€116.85 -
AAMI/ISO 11138-5:2017
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
8/1/2017 - Paper - English - AAMI
Learn More€145.60 -
AAMI/ISO 11138-5:2017
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
8/1/2017 - PDF - English - AAMI
Learn More€116.85 -
AAMI/ISO 11138-1:2017
Sterilization of health care products - Biological indicators - Part 1: General requirements
8/1/2017 - Paper - English - AAMI
Learn More€294.32 -
AAMI/ISO 11138-1:2017
Sterilization of health care products - Biological indicators - Part 1: General requirements
8/1/2017 - PDF - English - AAMI
Learn More€249.08 -
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
7/31/2017 - Paper - English - AAMI
Learn More€294.32 -
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
7/31/2017 - PDF - English - AAMI
Learn More€249.08 -
AAMI ST90:2017
Processing of health care products - Quality management systems for processing in health care facilities
7/18/2017 - Paper - English - AAMI
Learn More€278.72 -
AAMI ST90:2017
Processing of health care products - Quality management systems for processing in health care facilities
7/18/2017 - PDF - English - AAMI
Learn More€233.70 -
AAMI TIR21:2017
Systems Used to Forecast Remaining Pacemaker Battery Service Life
6/11/2017 - Paper - English - AAMI
Learn More€287.04 -
AAMI TIR21:2017
Systems Used to Forecast Remaining Pacemaker Battery Service Life
6/11/2017 - PDF - English - AAMI
Learn More€241.90 -
€327.60
-
€265.48
-
AAMI/ISO 25539-1:2017
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
5/25/2017 - Paper - English - AAMI
Learn More€266.24 -
AAMI/ISO 25539-1:2017
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
5/25/2017 - PDF - English - AAMI
Learn More€205.00 -
AAMI TIR69:2017
Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
4/28/2017 - Paper - English - AAMI
Learn More€294.32 -
AAMI TIR69:2017
Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
4/28/2017 - PDF - English - AAMI
Learn More€249.08 -
AAMI/ISO 14708-3:2017
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
3/2/2017 - Paper - English - AAMI
Learn More€278.72 -
AAMI/ISO 14708-3:2017
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
3/2/2017 - PDF - English - AAMI
Learn More€233.70 -
AAMI TIR66:2017
Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
2/28/2017 - Paper - English - AAMI
Learn More€235.04 -
AAMI TIR66:2017
Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
2/28/2017 - PDF - English - AAMI
Learn More€205.00 -
ANSI/AAMI/ISO 10993-6:2016
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
1/10/2017 - Paper - English - AAMI
Learn More€195.52 -
ANSI/AAMI/ISO 10993-6:2016
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
1/10/2017 - PDF - English - AAMI
Learn More€166.05 -
AAMI CI86:2017
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
1/6/2017 - Paper - English - AAMI
Learn More€351.52 -
AAMI CI86:2017
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
1/6/2017 - PDF - English - AAMI
Learn More€289.05 -
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 sécurisé - English - AAMI
Learn More€237.36 -
AAMI/ISO 25539-1:2017
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
1/1/2017 - PDF sécurisé - English - AAMI
Learn More€237.36 -
AAMI/ISO 14708-3:2017
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
1/1/2017 - PDF sécurisé - English - AAMI
Learn More€191.36 -
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 sécurisé - English - AAMI
Learn More€109.48 -
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 sécurisé - English - AAMI
Learn More€109.48 -
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 sécurisé - English - AAMI
Learn More€109.48 -
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 sécurisé - English - AAMI
Learn More€109.48 -
AAMI/ISO 15223-1:2016
Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
12/15/2016 - Paper - English - AAMI
Learn More€195.52 -
AAMI/ISO 15223-1:2016
Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
12/15/2016 - PDF - English - AAMI
Learn More€166.05 -
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
11/18/2016 - Paper - English - AAMI
Learn More€336.96 -
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
11/18/2016 - PDF - English - AAMI
Learn More€249.08 -
AAMI/ISO 15675:2016
Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
11/18/2016 - Paper - English - AAMI
Learn More€145.60 -
AAMI/ISO 15675:2016
Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
11/18/2016 - PDF - English - AAMI
Learn More€116.85 -
AAMI/ISO 18242:2016
Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
11/18/2016 - Paper - English - AAMI
Learn More€163.28 -
AAMI/ISO 18242:2016
Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
11/18/2016 - PDF - English - AAMI
Learn More€134.28 -
AAMI TIR28:2016
Product adoption and process equivalency for ethylene oxide sterilization
11/18/2016 - Paper - English - AAMI
Learn More€163.28 -
AAMI/ISO 15676:2016
Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
11/18/2016 - Paper - English - AAMI
Learn More€163.28 -
AAMI/ISO 7199:2016
Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
11/18/2016 - Paper - English - AAMI
Learn More€163.28 -
AAMI/ISO 7199:2016
Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
11/18/2016 - PDF - English - AAMI
Learn More€134.28 -
€195.52
-
€166.05
-
AAMI TIR28:2016
Product adoption and process equivalency for ethylene oxide sterilization
11/18/2016 - PDF - English - AAMI
Learn More€134.28 -
AAMI/ISO 22442-2:2016
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
11/17/2016 - Paper - English - AAMI
Learn More€163.28 -
AAMI/ISO 22442-2:2016
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
11/17/2016 - PDF - English - AAMI
Learn More€134.28 -
AAMI/ISO 22442-1:2016
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
11/17/2016 - Paper - English - AAMI
Learn More€206.96 -
AAMI/ISO 22442-1:2016
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
11/17/2016 - PDF - English - AAMI
Learn More€177.33 -
AAMI/ISO 15674:2016
Cardiovascular implants and artificial organs - Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
11/16/2016 - Paper - English - AAMI
Learn More€145.60 -
AAMI/ISO 15674:2016
Cardiovascular implants and artificial organs - Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
11/16/2016 - PDF - English - AAMI
Learn More€116.85 -
AAMI/ISO 18241:2016
Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
11/7/2016 - Paper - English - AAMI
Learn More€195.52 -
AAMI/ISO 18241:2016
Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
11/7/2016 - PDF - English - AAMI
Learn More€166.05 -
€235.04
-
€205.00
-
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
10/9/2016 - Paper - English - AAMI
Learn More€195.52 -
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
10/9/2016 - PDF - English - AAMI
Learn More€166.05 -
AAMI/IEC TIR80002-3:2016
Technical Information Report Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
8/12/2016 - Paper - English, French - AAMI
Learn More€277.68 -
AAMI/IEC TIR80002-3:2016
Technical Information Report Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
8/12/2016 - PDF - English, French - AAMI
Learn More€205.00 -
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
8/10/2016 - Paper - English - AAMI
Learn More€294.32 -
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
8/10/2016 - PDF - English - AAMI
Learn More€249.08 -
AAMI TIR74:2016
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
8/9/2016 - Paper - English - AAMI
Learn More€163.28 -
AAMI TIR74:2016
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
8/9/2016 - PDF - English - AAMI
Learn More€134.28 -
AAMI/ISO 80369-5:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
8/4/2016 - Paper - English - AAMI
Learn More€235.04 -
AAMI/ISO 80369-5:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
8/4/2016 - PDF - English - AAMI
Learn More€205.00 -
AAMI/ISO 80369-6:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
8/4/2016 - Paper - English - AAMI
Learn More€294.32 -
AAMI/ISO 80369-6:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
8/4/2016 - PDF - English - AAMI
Learn More€249.08 -
AAMI TIR57:2016
Principles for medical device security - Risk management
8/3/2016 - Paper - English - AAMI
Learn More€334.88 -
€289.05
-
AAMI/ISO 7198:2016
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
8/2/2016 - Paper - English - AAMI
Learn More€294.32 -
AAMI/ISO 7198:2016
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
8/2/2016 - PDF - English - AAMI
Learn More€249.08 -
AAMI/ISO 80369-3:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
6/5/2016 - Paper - English - AAMI
Learn More€294.32 -
AAMI/ISO 80369-3:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
6/5/2016 - PDF - English - AAMI
Learn More€249.08 -
AAMI TIR35:2016
Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
6/5/2016 - Paper - English - AAMI
Learn More€235.04 -
AAMI TIR35:2016
Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
6/5/2016 - PDF - English - AAMI
Learn More€205.00 -
€163.28
-
€134.28
-
AAMI/IEC 62304:2006/A1:2016
Medical device software - Software life cycle processes, Amendment 1
4/7/2016 - Paper - English - AAMI
Learn More€300.56 -
AAMI/IEC 62304:2006/A1:2016
Medical device software - Software life cycle processes, Amendment 1
4/7/2016 - PDF - English - AAMI
Learn More€213.20 -
AAMI/IEC 62304:2006 & A1:2016
Medical device software - Software life cycle processes - Consolidated Text
4/7/2016 - Paper - English - AAMI
Learn More€336.96 -
AAMI/IEC 62304:2006 & A1:2016
Medical device software - Software life cycle processes - Consolidated Text
4/7/2016 - PDF - English - AAMI
Learn More€249.08 -
AAMI/ISO 13485:2016(R2019)
Medical devices - Quality management systems - Requirements for regulatory purposes
3/25/2016 - Paper - English - AAMI
Learn More€294.32 -
AAMI/ISO 13485:2016(R2019)
Medical devices - Quality management systems - Requirements for regulatory purposes
3/25/2016 - PDF - English - AAMI
Learn More€249.08 -
Checklist for ISO 13485:2016, Medical Devices - Quality Management Systems- Requ
Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
3/1/2016 - Paper - English - AAMI
Learn More€213.20 -
Checklist for ISO 13485:2016, Medical Devices - Quality Management Systems- Requ
Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
3/1/2016 - PDF - English - AAMI
Learn More€306.48 -
AAMI/IEC TIR60878:2015
Graphical Symbols for Electrical Equipment in Medical Practice
1/3/2016 - Paper - English, French - AAMI
Learn More€537.68 -
AAMI/IEC TIR60878:2015
Graphical Symbols for Electrical Equipment in Medical Practice
1/3/2016 - PDF - English, French - AAMI
Learn More€446.90 -
AAMI/ISO 15223-2:2016
Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation
1/1/2016 - PDF sécurisé - English - AAMI
Learn More€109.48 -
AAMI/IEC 62304 AMD 1:2016
Medical device software - Software life cycle processes, Amendment 1
1/1/2016 - PDF sécurisé - English - AAMI
Learn More€191.36 -
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 and medical electrical systems intended for use in the emergency medical services environment
1/1/2016 - PDF sécurisé - English - AAMI
Learn More€204.24 -
AAMI/IEC 60601-2-21/A1:2016
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers, Amendment 1
1/1/2016 - PDF sécurisé - English - AAMI
Learn More€109.48 -
AAMI/IEC 60601-2-20/A1:2016
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of transport infant incubators, Amendment 1
1/1/2016 - PDF sécurisé - English - AAMI
Learn More€109.48 -
AAMI/IEC 60601-2-19/A1:2016
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators, Amendment 1
1/1/2016 - PDF sécurisé - English - AAMI
Learn More€109.48 -
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 sécurisé - English - AAMI
Learn More€204.24 -
AAMI/ISO 80369-5:2016
Small-bore connectors for liquids and gases in healthcare application - Part 5: Connectors for limb cuff inflation applications
1/1/2016 - PDF sécurisé - English - AAMI
Learn More€168.36 -
AAMI/ISO 80369-7:2016
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
1/1/2016 - PDF sécurisé - English - AAMI
Learn More€204.24 -
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 sécurisé - English - AAMI
Learn More€204.24 -
AAMI/ISO 7198:2016
Cardiovascular implants and extracorporeal systems - Vascular Prostheses - Tubular vascular grafts and vascular patches
1/1/2016 - PDF sécurisé - English - AAMI
Learn More€204.24 -
AAMI/ISO 7199:2016
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
1/1/2016 - PDF sécurisé - English - AAMI
Learn More€109.48 -
AAMI/ISO 15674:2016
Cardiovascular implants and artificial organs - Hardshell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
1/1/2016 - PDF sécurisé - English - AAMI
Learn More€95.68 -
AAMI/ISO 15675:2016
Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
1/1/2016 - PDF sécurisé - English - AAMI
Learn More€95.68 -
ANSI/AAMI/IEC 80601-2-58:2014/A1:2016
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery (Amendment 1)
1/1/2016 - PDF sécurisé - English - AAMI
Learn More€123.14 -
AAMI/IEC 60601-2-50/A1:2016
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment, Amendment 1
1/1/2016 - PDF sécurisé - English - AAMI
Learn More€95.68 -
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 sécurisé - English - AAMI
Learn More€109.48
