AAMI US Standards Standards

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
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€134.28

AAMI TIR105:2020

Risk management guidance for combination products
9/10/2020 - PDF - English - AAMI
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€134.28

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
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€21.53

AAMI/IEC 62366-1: 2015+AMD1:2020 (Consolidated Text)

Medical devices - Part 1: Application of usability engineering to medical devices, including Amendment 1
7/1/2020 - PDF - English - AAMI
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€249.08

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
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€249.08

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
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€249.08

AAMI/ISO 10993-11:2017

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
4/27/2020 - PDF - English - AAMI
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€205.00

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
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€233.70

AAMI RT3: 2020

Radiation therapy machine characterization
2/21/2020 - Paper - English - AAMI
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€39.52

AAMI RD47:2020

Reprocessing of hemodialyzers
1/23/2020 - Paper - English - AAMI
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€294.32

AAMI RD47:2020

Reprocessing of hemodialyzers
1/23/2020 - PDF - English - AAMI
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€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 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
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€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
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€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
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€289.05

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
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€166.05

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
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€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
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€166.05

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
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€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
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€205.00

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

€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
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€233.70

AAMI CR500:2019

Basic Introduction to the IEC 60601 Series
12/18/2019 - Paper - English - AAMI
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€195.52

AAMI CR500:2019

Basic Introduction to the IEC 60601 Series
12/18/2019 - PDF - English - AAMI
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€166.05

AAMI ST72:2019

Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
11/1/2019 - Paper - English - AAMI
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€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/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 TIR97:2019

Principles for medical device security - Postmarket risk management for device manufacturers
9/27/2019 - Paper - English - AAMI
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€294.32

AAMI TIR97:2019

Principles for medical device security - Postmarket risk management for device manufacturers
9/27/2019 - PDF - English - AAMI
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€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
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€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
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€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
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€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
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€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
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€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
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€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
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€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
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€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
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€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
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€205.00

AAMI/ISO 14971:2019

Medical devices - Application of risk management to medical devices
5/1/2019 - Paper - English - AAMI
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€279.76

AAMI/ISO 14971:2019

Medical devices - Application of risk management to medical devices
5/1/2019 - PDF - English - AAMI
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€249.08

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
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€113.78

AAMI EQ93:2019

Medical equipment management - Vocabulary used in medical equipment programs
4/18/2019 - Paper - English - AAMI
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€145.60

AAMI EQ93:2019

Medical equipment management - Vocabulary used in medical equipment programs
4/18/2019 - PDF - English - AAMI
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€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
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€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

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

€289.05

AAMI TIR38:2019

Medical device safety assurance case report guidance
1/25/2019 - Paper - English - AAMI
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€294.32

AAMI TIR38:2019

Medical device safety assurance case report guidance
1/25/2019 - PDF - English - AAMI
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€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
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€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
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€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
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€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

AAMI SW91:2018

Classification of defects in health software
11/2/2018 - Paper - English - AAMI
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€294.32

AAMI SW91:2018

Classification of defects in health software
11/2/2018 - PDF - English - AAMI
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€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
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€195.52

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

€233.70

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
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€205.00

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
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€205.00

AAMI/ISO TI(R2190)0:2018

Guidance for uncertainty analysis regarding the application of ISO/TS 10974
7/19/2018 - Paper - English - AAMI
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€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
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€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
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€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

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 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

AAMI TIR16:2017

162
11/17/2017 - Paper - English - AAMI
Learn More

€195.52

AAMI TIR16:2017

162
11/17/2017 - PDF - English - AAMI
Learn More

€166.05

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

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

AAMI TIR72:2017

Dialysis fluid chemical composition
9/8/2017 - Paper - English - AAMI
Learn More

€163.28

AAMI TIR72:2017

Dialysis fluid chemical composition
9/8/2017 - PDF - English - AAMI
Learn More

€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

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

€289.05

AAMI TIR71:2017

Guidance for logging of alarm system data
8/11/2017 - Paper - English - AAMI
Learn More

€163.28

AAMI TIR71:2017

Guidance for logging of alarm system data
8/11/2017 - PDF - English - AAMI
Learn More

€134.28

AAMI TIR59:2017

Integrating human factors into design controls
8/4/2017 - Paper - English - AAMI
Learn More

€235.04

AAMI TIR59:2017

Integrating human factors into design controls
8/4/2017 - PDF - English - AAMI
Learn More

€205.00

AAMI/ISO 11138-1:2017

Sterilization of health care products - Biological indicators - Part 1: General requirements
8/1/2017 - Paper - English - AAMI
Learn More

€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 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 11138-2:2017

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 11138-4:2017

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 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/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

€249.08

AAMI TIR17:2017

Compatibility of materials subject to sterilization
6/11/2017 - Paper - English - AAMI
Learn More

€327.60

AAMI TIR17:2017

Compatibility of materials subject to sterilization
6/11/2017 - PDF - English - AAMI
Learn More

€265.48

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

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 (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

€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/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 25539-1:2017

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
1/1/2017 - PDF sécurisé - English - AAMI
Learn More

€237.36

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
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€237.36

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
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€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
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€109.48

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
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€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
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€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
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€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
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€166.05

AAMI TIR15:2016

Physical aspects of ethylene oxide sterilization
11/18/2016 - Paper - English - AAMI
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€195.52

AAMI TIR15:2016

Physical aspects of ethylene oxide sterilization
11/18/2016 - PDF - English - AAMI
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€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
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€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
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€249.08

AAMI/ISO 7199:2016

Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
11/18/2016 - Paper - English - AAMI
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€163.28

AAMI/ISO 7199:2016

Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
11/18/2016 - PDF - English - AAMI
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€134.28

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 15675:2016

Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
11/18/2016 - Paper - English - AAMI
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€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 TIR28:2016

Product adoption and process equivalency for ethylene oxide sterilization
11/18/2016 - PDF - English - AAMI
Learn More

€134.28

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 - 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 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 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

AAMI ST55:2016

Table-Top Steam Sterilizers
11/1/2016 - Paper - English - AAMI
Learn More

€235.04

AAMI ST55:2016

Table-Top Steam Sterilizers
11/1/2016 - PDF - English - AAMI
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€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