AAMI
-
AAMI 2700-2-1: 2022:2022
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
4/22/2022 - Paper - English - AAMI
Learn More€355.00 -
AAMI 2700-2-1: 2022:2022
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
4/22/2022 - PDF - English - AAMI
Learn More€266.00 -
AAMI TIR104:2022
Guidance on transferring health care products between radiation sterilization sources
4/19/2022 - Paper - English - AAMI
Learn More€322.00 -
AAMI TIR104:2022
Guidance on transferring health care products between radiation sterilization sources
4/19/2022 - PDF - English - AAMI
Learn More€233.00 -
AAMI CR34971:2022
Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
4/1/2022 - Paper - English - AAMI
Learn More€322.00 -
AAMI CR34971:2022
Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
4/1/2022 - PDF - English - AAMI
Learn More€233.00 -
AAMI HA60601-1-11:2015/A1:2021:2022
Amendment 1, 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 (IEC 60601-1-11:2015, MOD)
3/20/2022 - Paper - English - AAMI
Learn More€190.00 -
AAMI HA60601-1-11:2015/A1:2021:2022
Amendment 1, 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 (IEC 60601-1-11:2015, MOD)
3/20/2022 - PDF - English - AAMI
Learn More€129.00 -
AAMI ES60601-1: 2005/A2:2021:2022
Amendment 2, Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
3/1/2022 - Paper - English - AAMI
Learn More€364.00 -
AAMI ES60601-1: 2005/A2:2021:2022
Amendment 2, Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
3/1/2022 - PDF - English - AAMI
Learn More€275.00 -
AAMI HIT1000-1: 2022:2022
Safety and effectiveness of health IT software and systems-Part 1: Fundamental concepts, principles, and requirements
3/1/2022 - Paper - English - AAMI
Learn More€355.00 -
AAMI HIT1000-1: 2022:2022
Safety and effectiveness of health IT software and systems-Part 1: Fundamental concepts, principles, and requirements
3/1/2022 - PDF - English - AAMI
Learn More€266.00 -
AAMI ST91:2021
Flexible and semi-rigid endoscope processing in health care facilities
12/21/2021 - Paper - English - AAMI
Learn More€473.00 -
AAMI ST91:2021
Flexible and semi-rigid endoscope processing in health care facilities
12/21/2021 - PDF - English - AAMI
Learn More€384.00 -
€275.00
-
AAMI CR510:2021
Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
9/24/2021 - PDF - English - AAMI
Learn More€129.00 -
AAMI PC76:2021
Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
4/1/2021 - PDF - English - AAMI
Learn More€310.00 -
AAMI TIR42:2021
Evaluation of particulate associated with vascular medical devices
3/31/2021 - PDF - English - AAMI
Learn More€259.00 -
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
3/31/2021 - PDF - English - AAMI
Learn More€259.00 -
AAMI TIR43:2021
Ultrapure dialysis fluid for hemodialysis and related therapies
2/26/2021 - PDF - English - AAMI
Learn More€259.00 -
AAMI/ISO 14155:2020
Clinical investigation of medical devices for human subjects - Good clinical practice
12/7/2020 - PDF - English - AAMI
Learn More€319.00 -
AAMI/ISO 10993-16:2017:2020
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
11/6/2020 - PDF - English - AAMI
Learn More€149.00 -
AAMI/ISO 10993-15:2019:2020
Biological evaluation of medical devices?Part 15: Identification and quantification of degradation products from metals and alloys
10/5/2020 - PDF - English - AAMI
Learn More€149.00 -
AAMI TIR12:2020
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
9/17/2020 - PDF - English - AAMI
Learn More€275.00 -
€259.00
-
AAMI/IEC 60601-2-39:2018:2020
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
8/26/2020 - PDF - English - AAMI
Learn More€227.00 -
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
8/3/2020 - PDF - English - AAMI
Learn More€249.08 -
AAMI/IEC 60601-2-16:2018:2020
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
7/22/2020 - PDF - English - AAMI
Learn More€275.00 -
AAMI HIT1000-4 (PS):2020
Safety and effectiveness of health IT software and systems - Part 4: Application of human factors engineering
7/7/2020 - PDF - English - AAMI
Learn More€24.00 -
AAMI/IEC 62366-1: 2015+AMD1:2020 (Consolidated Text) (R2021)
Medical devices - Part 1: Application of usability engineering to medical devices, including Amendment 1
7/1/2020 - PDF - English - AAMI
Learn More€275.00 -
AAMI/ISO 8637-1:2017:2020
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
7/1/2020 - PDF - English - AAMI
Learn More€227.00 -
AAMI/ISO 8637-3:2018:2020
Extracorporeal systems for blood purification - Part 3: Plasmafilters
7/1/2020 - PDF - English - AAMI
Learn More€184.00 -
AAMI/ISO 8637-2:2018:2020
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
7/1/2020 - PDF - English - AAMI
Learn More€184.00 -
AAMI/ISO 10993-4:2017
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
4/27/2020 - PDF - English - AAMI
Learn More€275.00 -
AAMI/ISO 10993-1:2018
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
4/27/2020 - PDF - English - AAMI
Learn More€275.00 -
AAMI/ISO 10993-11:2017
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
4/27/2020 - PDF - English - AAMI
Learn More€227.00 -
AAMI MP80601-2-49:2020
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
3/24/2020 - PDF - English - AAMI
Learn More€259.00 -
€42.00
-
€0.00
-
AAMI/ISO TI (R2041)6:2020
Medical devices - Post-market surveillance for manufacturers
2/16/2020 - PDF - English - AAMI
Learn More€267.00 -
AAMI/ISO TI (R2497)1:2020
Medical devices - Guidance on the application of ISO 14971
2/2/2020 - PDF - English - AAMI
Learn More€319.00 -
€364.00
-
€275.00
-
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€209.00 -
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€147.00 -
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€206.00 -
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€144.00 -
AAMI/ISO 80369-3:2016/A1:2019
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment
12/30/2019 - PDF - English - AAMI
Learn More€134.28 -
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€408.00 -
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€319.00 -
AAMI/ISO 23500-3:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
12/23/2019 - Paper - English - AAMI
Learn More€245.00 -
AAMI/ISO 23500-3:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
12/23/2019 - PDF - English - AAMI
Learn More€184.00 -
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€245.00 -
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 - PDF - English - AAMI
Learn More€184.00 -
AAMI/ISO 23500-4:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
12/23/2019 - Paper - English - AAMI
Learn More€300.00 -
AAMI/ISO 23500-4:2019
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
12/23/2019 - PDF - English - AAMI
Learn More€227.00 -
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
12/23/2019 - Paper - English - AAMI
Learn More€348.00 -
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
12/23/2019 - PDF - English - AAMI
Learn More€259.00 -
€245.00
-
€184.00
-
AAMI ST72:2019
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
11/1/2019 - Paper - English - AAMI
Learn More€364.00 -
AAMI ST72:2019
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing, Includes Erratum (2020)
11/1/2019 - PDF - English - AAMI
Learn More€275.00 -
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€364.00 -
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€275.00 -
AAMI TIR97:2019
Principles for medical device security - Postmarket risk management for device manufacturers
9/27/2019 - Paper - English - AAMI
Learn More€364.00 -
AAMI TIR97:2019
Principles for medical device security - Postmarket risk management for device manufacturers
9/27/2019 - PDF - English - AAMI
Learn More€275.00 -
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€408.00 -
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€319.00 -
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€408.00 -
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€319.00 -
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€210.00 -
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€149.00 -
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
7/11/2019 - Paper - English - AAMI
Learn More€245.00 -
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
7/11/2019 - PDF - English - AAMI
Learn More€184.00 -
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
7/1/2019 - Paper - English - AAMI
Learn More€300.00 -
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
7/1/2019 - PDF - English - AAMI
Learn More€227.00 -
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€300.00 -
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€227.00 -
AAMI/ISO 14971:2019
Medical devices - Application of risk management to medical devices
5/1/2019 - Paper - English - AAMI
Learn More€364.00 -
AAMI/ISO 14971:2019
Medical devices - Application of risk management to medical devices
5/1/2019 - PDF - English - AAMI
Learn More€275.00 -
AAMI/ISO 11137-1:2006 (R2015) A2:2019
A2:2019 to Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
5/1/2019 - PDF - English - AAMI
Learn More€113.78 -
AAMI EQ93:2019
Medical equipment management - Vocabulary used in medical equipment programs
4/18/2019 - Paper - English - AAMI
Learn More€190.00 -
AAMI EQ93:2019
Medical equipment management - Vocabulary used in medical equipment programs
4/18/2019 - PDF - English - AAMI
Learn More€129.00 -
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€348.00 -
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€259.00 -
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€558.00 -
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€469.00 -
AAMI/IEC 60601-2-4:2010/A1:2018 (Consolidated Text)
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
1/30/2019 - PDF - English - AAMI
Learn More€319.00 -
AAMI/IEC 80601-2-30:2018:2019
Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
1/30/2019 - PDF - English - AAMI
Learn More€249.08 -
€364.00
-
€275.00
-
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€245.00 -
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€184.00 -
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€210.00 -
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€149.00 -
€344.24
-
€256.25
-
AAMI HIT1000-1 (PS):2018
Safety and effectiveness of health IT software and systems - Part 1: Fundamental concepts, principles, and requirements
10/1/2018 - PDF - English - AAMI
Learn More€0.00 -
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€226.72 -
AAMI/IEC 60601-2-20:2009 (R2014) & A1:2016
Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
9/1/2018 - PDF - English - AAMI
Learn More€259.00 -
AAMI/IEC 60601-2-19:2009 (R2014) & A1:2016
Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
9/1/2018 - PDF - English - AAMI
Learn More€227.00 -
AAMI/IEC 60601-2-21:2009 (R2014) & A1:2016
Medical Electrical Equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
9/1/2018 - PDF - English - AAMI
Learn More€205.00 -
AAMI/IEC 60601-2-50:2009:2018 (R2014) & A1:2016
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
9/1/2018 - PDF - English - AAMI
Learn More€184.00 -
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€198.64 -
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€138.38 -
AAMI TIR77:2018
Technical Information Report Sorbent-based regenerative hemodialysis systems
6/8/2018 - Paper - English - AAMI
Learn More€245.00 -
AAMI TIR77:2018
Technical Information Report Sorbent-based regenerative hemodialysis systems
6/8/2018 - PDF - English - AAMI
Learn More€184.00 -
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€431.00 -
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€342.00 -
AAMI TIR67:2018 (R2022)
Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
4/25/2018 - Paper - English - AAMI
Learn More€373.00 -
AAMI TIR67:2018 (R2022)
Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
4/25/2018 - PDF - English - AAMI
Learn More€284.00 -
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€245.00 -
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€184.00 -
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€257.00 -
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€196.00 -
€245.00
-
AAMI TIR16:2017 (R2020)
Microbiological aspects of ethylene oxide sterilization
11/17/2017 - PDF - English - AAMI
Learn More€184.00 -
AAMI/ISO 13408-2:2018
Aseptic processing of health care products - Part 2:Sterilizing filtration
11/17/2017 - Paper - English - AAMI
Learn More€210.00 -
AAMI/ISO 13408-2:2018
Aseptic processing of health care products - Part 2:Sterilizing filtration
11/17/2017 - PDF - English - AAMI
Learn More€149.00 -
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€210.00 -
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€149.00 -
AAMI ST79:2017
Comprehensive guide to steam sterilization and sterility assurance in health care facilities with Amendments A1:2020, A2:2020, A3:2020, A4:2020
10/1/2017 - Paper - English - AAMI
Learn More€521.04 -
AAMI ST79:2017
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
with amendments A1:2020, A2:2020, A3:2020, A4:2020
10/1/2017 - PDF - English - AAMI
Learn More€430.50 -
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€344.24 -
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€256.25 -
€210.00
-
€149.00
-
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€240.00 -
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€178.00 -
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€300.00 -
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€227.00 -
AAMI/ISO TIR80002-2:2017
Medical device software - Part 2: Validation of software for medical device quality systems
8/18/2017 - PDF - English, French - AAMI
Learn More€319.00 -
€198.64
-
€138.38
-
€300.00
-
€227.00
-
AAMI/ISO 11138-1:2017
Sterilization of health care products - Biological indicators - Part 1: General requirements
8/1/2017 - Paper - English - AAMI
Learn More€364.00 -
AAMI/ISO 11138-1:2017
Sterilization of health care products - Biological indicators - Part 1: General requirements
8/1/2017 - PDF - English - AAMI
Learn More€275.00 -
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€179.92 -
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€119.93 -
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€190.00 -
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€129.00 -
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€190.00 -
AAMI/ISO 11138-4:2017
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
8/1/2017 - PDF - English - AAMI
Learn More€129.00 -
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€190.00 -
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€129.00 -
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
7/31/2017 - Paper - English - AAMI
Learn More€364.00 -
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
7/31/2017 - PDF - English - AAMI
Learn More€275.00 -
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€328.64 -
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€240.88 -
AAMI/IEC 60601-2-2:2017
Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
6/30/2017 - PDF - English - AAMI
Learn More€275.00 -
€361.92
-
€273.68
-
AAMI TIR21:2017 (R2020)
Systems Used to Forecast Remaining Pacemaker Battery Service Life
6/11/2017 - Paper - English - AAMI
Learn More€344.24 -
AAMI TIR21:2017 (R2020)
Systems Used to Forecast Remaining Pacemaker Battery Service Life
6/11/2017 - PDF - English - AAMI
Learn More€256.25 -
€0.00
-
AAMI/ISO 25539-1:2017
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
5/25/2017 - Paper - English - AAMI
Learn More€300.00 -
AAMI/ISO 25539-1:2017
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
5/25/2017 - PDF - English - AAMI
Learn More€227.00 -
AAMI TIR69:2017 (R2020)
Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
4/28/2017 - Paper - English - AAMI
Learn More€344.24 -
AAMI TIR69:2017 (R2020)
Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
4/28/2017 - PDF - English - AAMI
Learn More€256.25 -
AAMI/ISO 14708-3:2017
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
3/2/2017 - Paper - English - AAMI
Learn More€348.00 -
AAMI/ISO 14708-3:2017
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
3/2/2017 - PDF - English - AAMI
Learn More€259.00 -
AAMI TIR66:2017 (R2020)
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€283.92 -
AAMI TIR66:2017 (R2020)
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€211.15 -
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€245.00 -
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€184.00 -
AAMI CI86:2017
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
1/6/2017 - Paper - English - AAMI
Learn More€408.00 -
AAMI CI86:2017
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
1/6/2017 - PDF - English - AAMI
Learn More€319.00 -
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€245.00 -
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€184.00 -
€245.00
-
€184.00
-
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
11/18/2016 - Paper - English - AAMI
Learn More€364.00 -
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
11/18/2016 - PDF - English - AAMI
Learn More€275.00 -
AAMI/ISO 7199:2016
Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
11/18/2016 - Paper - English - AAMI
Learn More€210.00 -
AAMI/ISO 7199:2016
Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
11/18/2016 - PDF - English - AAMI
Learn More€149.00 -
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€210.00 -
AAMI/ISO 15675:2016
Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
11/18/2016 - Paper - English - AAMI
Learn More€190.00 -
AAMI/ISO 15675:2016
Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
11/18/2016 - PDF - English - AAMI
Learn More€129.00 -
AAMI/ISO 18242:2016
Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
11/18/2016 - Paper - English - AAMI
Learn More€198.64 -
AAMI/ISO 18242:2016
Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
11/18/2016 - PDF - English - AAMI
Learn More€138.38 -
AAMI TIR28:2016 (R2020)
Product adoption and process equivalency for ethylene oxide sterilization
11/18/2016 - Paper - English - AAMI
Learn More€210.00 -
AAMI TIR28:2016 (R2020)
Product adoption and process equivalency for ethylene oxide sterilization
11/18/2016 - PDF - English - AAMI
Learn More€149.00 -
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 - PDF - English - AAMI
Learn More€149.00 -
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€257.00 -
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€196.00 -
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€210.00 -
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€149.00 -
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€190.00 -
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€129.00 -
AAMI/ISO 18241:2016
Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
11/7/2016 - Paper - English - AAMI
Learn More€231.92 -
AAMI/ISO 18241:2016
Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
11/7/2016 - PDF - English - AAMI
Learn More€171.18 -
€283.92
-
€211.15
-
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€245.00 -
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 - PDF - English - AAMI
Learn More€184.00 -
AAMI/IEC 60601-1-12:2016
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performan - Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
10/6/2016 - PDF - English - AAMI
Learn More€249.08 -
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€300.00 -
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€227.00 -
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€364.00
