AAMI US Standards Standards

AAMI TIR45:2023

Guidance on the use of agile practices in the development of medical device software
3/15/2023 - PDF - English - AAMI
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€330.00

AAMI TIR34971:2023

Application of ISO 14971 to machine learning in artificial intelligence—Guide
3/14/2023 - PDF - English - AAMI
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€233.00

AAMI/ISO 15223-1:2022:2023

Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
1/9/2023 - PDF - English - AAMI
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€266.00

AAMI/ISO TI:2022 (R2245)6: 2022

Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
12/27/2022 - PDF - English - AAMI
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€189.00

AAMI SW96:2023:2022

Standard for medical device security—Security risk management for device manufacturers
12/21/2022 - PDF - English - AAMI
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€285.00

AAMI/ISO 17664-1:2022

Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices
12/21/2022 - PDF - English - AAMI
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€233.00

AAMI/ISO 17664-2:2022

Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices
12/21/2022 - PDF - English - AAMI
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€233.00

AAMI ST98:2022

Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
8/22/2022 - PDF - English - AAMI
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€259.00

AAMI HA60601-1-11:2015 & A1:2021:2022

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) CONSOLIDATED EDITION
8/22/2022 - PDF - English - AAMI
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€277.00

AAMI ES60601-1: 2005 & A1:2012 & A2:2021:2022

Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) CONSOLIDATED EDITION
8/22/2022 - PDF - English - AAMI
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€1,168.00

AAMI ST44 : 2002

Resistometers used for characterizing the performance of biological and chemical indicators
7/10/2022 - PDF - English - AAMI
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€86.00

AAMI/ISO TIR 11137-4:2022

Sterilization of health care products-Radiation-Part 4: Guidance on process control
6/12/2022 - PDF - English - AAMI
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€276.00

AAMI 2800-1-2:2022

Standard for Interoperable Item Development Life Cycle (ANSI/AAMI/UL 2800-1-2:2022)
6/10/2022 - PDF - English - AAMI
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€259.00

AAMI 2800-1:2022

Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2022)
6/10/2022 - PDF - English - AAMI
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€320.00

AAMI 2800-1-3:2022

Standard for Interoperable Item Integration Life Cycle (ANSI/AAMI/UL 2800-1-3:2022)
6/10/2022 - PDF - English - AAMI
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€227.00

AAMI 2800-1-1:2022

Standard for Risk Concerns for Interoperable Medical Products (ANSI/AAMI/UL 2800-1-1:2022)
6/10/2022 - PDF - English - AAMI
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€276.00

AAMI TIR100: 2021:2022

End-to-end microbiological quality and sterility assurance
5/10/2022 - PDF - English - AAMI
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€184.00

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
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€259.00

AAMI TIR104:2022

Guidance on transferring health care products between radiation sterilization sources
4/19/2022 - PDF - English - AAMI
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€227.00

AAMI CR34971:2022

Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
4/1/2022 - PDF - English - AAMI
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€227.00

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
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€125.00

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
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€268.00

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
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€259.00

AAMI ST91:2021

Flexible and semi-rigid endoscope processing in health care facilities
12/21/2021 - PDF - English - AAMI
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€373.00

AAMI TIR58:2021

Water testing methodologies
12/21/2021 - PDF - English - AAMI
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€251.00

AAMI/ISO CN27:2021

General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
12/6/2021 - PDF - English - AAMI
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€220.00

AAMI TIR 101:2021

Fluid delivery performance testing for infusion pumps
10/15/2021 - PDF - English - AAMI
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€268.00

AAMI CR510:2021

Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
9/24/2021 - PDF - English - AAMI
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€125.00

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
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€302.00

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
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€251.00

AAMI TIR42:2021

Evaluation of particulate associated with vascular medical devices
3/31/2021 - PDF - English - AAMI
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€251.00

AAMI TIR43:2021

Ultrapure dialysis fluid for hemodialysis and related therapies
2/26/2021 - PDF - English - AAMI
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€251.00

AAMI/ISO 14155:2020

Clinical investigation of medical devices for human subjects - Good clinical practice
12/7/2020 - PDF - English - AAMI
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€310.00

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
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€144.00

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
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€144.00

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
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€268.00

AAMI TIR105:2020

Risk management guidance for combination products
9/10/2020 - PDF - English - AAMI
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€251.00

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
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€220.00

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
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€268.00

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
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€24.00

AAMI/ISO 8637-1:2017:2020

Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
7/1/2020 - PDF - English - AAMI
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€220.00

AAMI/ISO 8637-3:2018:2020

Extracorporeal systems for blood purification - Part 3: Plasmafilters
7/1/2020 - PDF - English - AAMI
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€179.00

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
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€179.00

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
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€268.00

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
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€268.00

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
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€268.00

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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€220.00

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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€251.00

AAMI/ISO TI (R2041)6:2020

Medical devices - Post-market surveillance for manufacturers
2/16/2020 - PDF - English - AAMI
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€260.00

AAMI/ISO TI (R2497)1:2020

Medical devices - Guidance on the application of ISO 14971
2/2/2020 - PDF - English - AAMI
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€310.00

AAMI RD47:2020

Reprocessing of hemodialyzers
1/23/2020 - PDF - English - AAMI
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€268.00

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
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€143.00

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
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€140.00

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

€310.00

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

€179.00

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
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€179.00

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
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€220.00

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
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€251.00

AAMI CR500:2019

Basic Introduction to the IEC 60601 Series
12/18/2019 - PDF - English - AAMI
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€179.00

AAMI ST72:2019

Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing, Includes Erratum (2020)
11/1/2019 - PDF - English - AAMI
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€268.00

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
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€268.00

AAMI TIR97:2019 (R2023)

Principles for medical device security - Postmarket risk management for device manufacturers
9/27/2019 - PDF - English - AAMI
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€285.00

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
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€310.00

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
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€310.00

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
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€144.00

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
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€179.00

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
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€220.00

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
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€220.00

AAMI/ISO 14971:2019

Medical devices - Application of risk management to medical devices
5/1/2019 - PDF - English - AAMI
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€268.00

AAMI EQ93:2019

Medical equipment management - Vocabulary used in medical equipment programs
4/18/2019 - PDF - English - AAMI
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€125.00

AAMI/ISO 81060-2:2019

Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
3/22/2019 - PDF - English - AAMI
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€251.00

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
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€310.00

AAMI TIR38:2019

Medical device safety assurance case report guidance
1/25/2019 - PDF - English - AAMI
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€268.00

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
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€179.00

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
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€144.00

AAMI SW91:2018

Classification of defects in health software
11/2/2018 - PDF - English - AAMI
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€268.00

AAMI TIR68:2018 (R2022)

Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
9/30/2018 - PDF - English - AAMI
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€227.00

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
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€251.00

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
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€220.00

AAMI/ISO TI(R2190)0:2018

Guidance for uncertainty analysis regarding the application of ISO/TS 10974
7/19/2018 - PDF - English - AAMI
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€144.00

AAMI TIR77:2018

Technical Information Report Sorbent-based regenerative hemodialysis systems
6/8/2018 - PDF - English - AAMI
Learn More

€179.00

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

€333.00

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
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€276.00

AAMI TIR40:2018 (R2022)

Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
1/31/2018 - PDF - English - AAMI
Learn More

€189.00

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

€190.00

AAMI TIR16:2017 (R2020)

Microbiological aspects of ethylene oxide sterilization
11/17/2017 - PDF - English - AAMI
Learn More

€179.00

AAMI/ISO 13408-2:2018

Aseptic processing of health care products - Part 2:Sterilizing filtration
11/17/2017 - PDF - English - AAMI
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€144.00

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
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€144.00

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
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€268.00

AAMI TIR72:2017

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

€144.00

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

€173.00

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

€220.00

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
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€310.00

AAMI TIR71:2017/ (R2020)

Guidance for logging of alarm system data
8/11/2017 - PDF - English - AAMI
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€144.00

AAMI TIR59:2017

Integrating human factors into design controls
8/4/2017 - PDF - English - AAMI
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€220.00

AAMI/ISO 11138-1:2017

Sterilization of health care products - Biological indicators - Part 1: General requirements
8/1/2017 - PDF - English - AAMI
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€268.00

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 - PDF - English - AAMI
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€125.00

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
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€125.00

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
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€125.00

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

€125.00

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
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€268.00

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

€251.00

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

€268.00

AAMI TIR21:2017 (R2020)

Systems Used to Forecast Remaining Pacemaker Battery Service Life
6/11/2017 - PDF - English - AAMI
Learn More

€268.00

AAMI/ISO 25539-1:2017

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
5/25/2017 - PDF - English - AAMI
Learn More

€220.00

AAMI/ISO 14708-3:2017

Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
3/2/2017 - PDF - English - AAMI
Learn More

€251.00

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

€179.00

AAMI CI86:2017

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
1/6/2017 - PDF - English - AAMI
Learn More

€310.00

AAMI TIR15:2016 (R2020)

Physical aspects of ethylene oxide sterilization
11/18/2016 - PDF - English - AAMI
Learn More

€179.00

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
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€268.00

AAMI/ISO 7199:2016

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

€144.00

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

€144.00

AAMI/ISO 15675:2016

Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
11/18/2016 - PDF - English - AAMI
Learn More

€125.00

AAMI/ISO 18242:2016

Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
11/18/2016 - PDF - English - AAMI
Learn More

€144.00

AAMI TIR28:2016 (R2020)

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

€144.00

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

€190.00

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

€144.00

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

€125.00

AAMI/ISO 18241:2016

Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
11/7/2016 - PDF - English - AAMI
Learn More

€179.00

AAMI ST55:2016 (R2023)

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

€233.00

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

€179.00

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
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€220.00

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 - PDF - English - AAMI
Learn More

€268.00

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

€144.00

AAMI/ISO 80369-6:2016

Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
8/4/2016 - PDF - English - AAMI
Learn More

€268.00

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

€220.00

AAMI TIR57:2016 (R2019) (R2023)

Principles for medical device security - Risk management
8/3/2016 - PDF - English - AAMI
Learn More

€330.00

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

€268.00

AAMI TIR14:2016 (R2020)

Contract sterilization using ethylene oxide
6/5/2016 - PDF - English - AAMI
Learn More

€144.00

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

€268.00

AAMI TIR35:2016 (R2021)

Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
6/4/2016 - PDF - English - AAMI
Learn More

€220.00

AAMI/IEC 62304:2006/A1:2016

Medical device software - Software life cycle processes, Amendment 1
4/7/2016 - PDF - English - AAMI
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€223.00

AAMI/IEC 62304:2006 & A1:2016

Medical device software - Software life cycle processes - Consolidated Text
4/7/2016 - PDF - English - AAMI
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€268.00

AAMI/ISO 13485:2016(R2019)

Medical devices - Quality management systems - Requirements for regulatory purposes
3/25/2016 - PDF - English - AAMI
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€268.00

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
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€353.00

AAMI/IEC TIR60878:2015

Graphical Symbols for Electrical Equipment in Medical Practice
1/3/2016 - PDF - English, French - AAMI
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€480.00

AAMI TIR65:2015

Sustainability of medical devices--Elements of a responsible product life cycle
1/1/2016 - PDF - English - AAMI
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€251.00

AAMI/ISO 12417-1:2015

Cardiovascular implants and extracorporeal systems - Vascular device-drugcombination products - Part 1: General requirements
11/15/2015 - PDF - English - AAMI
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€221.00

SEPT IEC 62304 Checklist:2015

IEC 62304:2015, Medical Device Software - Software Life Cycle Processes
10/20/2015 - PDF - English - AAMI
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€353.00

AAMI TIR48:2015 (R2021)

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
8/14/2015 - PDF - English - AAMI
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€179.00

AAMI/IEC TIR80001-2-6:2014

Application of risk management for IT-networks incorporating medical - Application guidance - Part 2-6: Guidance for responsibility agreements
8/9/2015 - PDF - English - AAMI
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€144.00

AAMI/ISO 11135:2014

Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
7/27/2015 - PDF - English - AAMI
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€310.00

AAMI/ISO 80369-20:2015

Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
3/30/2015 - PDF - English - AAMI
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€251.00

AAMI EQ89:2015 (R2023)

Guidance for the use of medical equipment maintenance strategies and procedures
2/6/2015 - PDF - English - AAMI
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€153.00

AAMI/IEC TIR80001-2-5:2014

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
12/24/2014 - PDF - English - AAMI
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€220.00

AAMI/IEC TIR80001-2-7:2014

Application of risk management for IT-networks incorporating medical - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
12/24/2014 - PDF - English - AAMI
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€310.00

AAMI TIR55:2014(R2017)

Human factors engineering for processing medical devices
12/23/2014 - PDF - English - AAMI
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€179.00

AAMI TIR63:2014(R2017) (R2023)

Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
12/23/2014 - PDF - English - AAMI
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€153.00

AAMI/ISO TIR37137:2014

Cardiovascular biological evaluation of medical device - Guidance for absorbable implants
11/28/2014 - PDF - English - AAMI
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€144.00

AAMI TIR61:2014 (R2019)

Generating reports for human factors design validation results for external cardiac defibrillators
10/24/2014 - PDF - English - AAMI
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€144.00

AAMI TIR60:2014(R2019)

Common mode rejection in ECG monitoring
10/24/2014 - PDF - English - AAMI
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€144.00

AAMI TIR51:2014(R2017)

Human factors engineering - Guidance for contextual inquiry
10/24/2014 - PDF - English - AAMI
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€144.00

AAMI TIR62:2014(R2019)

Generating reports for the purpose of submitting defibrillation waveform data for evaluation
10/24/2014 - PDF - English - AAMI
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€125.00

AAMI/ISO 14708-1:2014

Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
10/8/2014 - PDF - English - AAMI
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€268.00

AAMI/ISO 11140-1:2014

Sterilization of health care products - Chemical indicators - Part 1: General requirements
9/10/2014 - PDF - English - AAMI
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€179.00

AAMI/ISO 10993-3:2014

Biological evaluation of medical devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
8/14/2014 - PDF - English - AAMI
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€144.00

AAMI/ISO TI(R1677)5:2014

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
7/27/2014 - PDF - English - AAMI
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€310.00

AAMI/ISO 5841-2:2014

Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
7/21/2014 - PDF - English - AAMI
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€168.00

AAMI/ISO TI(R1766)5-3:2014/(R)2016

Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical product to a product family and processing category for steam sterilization
5/18/2014 - PDF - English - AAMI
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€268.00

AAMI/ISO TI(R1713)7:2014

Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
5/4/2014 - PDF - English - AAMI
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€173.00

AAMI TIR50:2014(R2017)

Post-market surveillance of use error management
3/10/2014 - PDF - English - AAMI
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€214.00

AAMI TIR52:2014(R2017) (R2023)

Environmental Monitoring For Terminally Sterilized Healthcare Products
3/10/2014 - PDF - English - AAMI
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€134.00

AAMI TIR37:2013

Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products.
12/30/2013 - PDF - English - AAMI
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€144.00

AAMI/ISO 11137-1:2006(R2015) & A1:2003 & A2:2019 (Consolidated Text)

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices, Includes A1:2013 & A2:2019
12/30/2013 - PDF - English - AAMI
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€268.00

AAMI TIR56:2013(R2016) (R2020)

Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
12/27/2013 - PDF - English - AAMI
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€179.00

AAMI ST79:2010/A4:2013 (R2014)

Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Amendment 4
10/14/2013 - PDF - English - AAMI
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€102.00

AAMI/ISO TI(R1300)4:2013/(R)2016

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmaxSD
10/4/2013 - PDF - English - AAMI
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€268.00

AAMI AT6:2013

Autologous transfusion devices
8/27/2013 - PDF - English - AAMI
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€140.00

AAMI/ISO TI(R1921)8-1:2011/A1:2013

Medical devices - Hierarchal coding structure for adverse events - Part 1: Event type codes, Amendment 1
8/1/2013 - PDF - English - AAMI
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€71.00

AAMI/ISO 5841-3:2013 (R2018)

Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
7/29/2013 - PDF - English - AAMI
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€132.00

AAMI/ISO 11137-2:2013(R2019)

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
7/10/2013 - PDF - English - AAMI
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€268.00

AAMI/IEC TIR80001-2-4:2012

Application of risk management for IT-networks incorporating medical devices -- Part 2-4: General implementation guidance for healthcare delivery organizations
4/30/2013 - PDF - English - AAMI
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€179.00

AAMI ST8:2013 (R2018)

Hospital steam sterilizers
4/25/2013 - PDF - English - AAMI
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€220.00

AAMI/ISO 13408-1:2008(R2011)/A1:2013

Aseptic processing of health care products--Part 1: General requirements, Amendment 1
3/27/2013 - PDF - English - AAMI
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€71.00

AAMI TIR49:2013 (R2020)

Design of training and instructional materials for medical devices used in non-clinical environments
3/19/2013 - PDF - English - AAMI
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€251.00

AAMI EQ56:2013

Recommended practices for a medical equipment management program
3/13/2013 - PDF - English - AAMI
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€220.00

AAMI/ISO 13408-6:2005/A1:2013

Aseptic processing of health care products - Part 6: Isolator systems, Amendment 1
3/11/2013 - PDF - English - AAMI
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€73.00

AAMI ST77:2013 (R2018)

Containment devices for reusable medical device sterilization
2/1/2013 - PDF - English - AAMI
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€179.00

AAMI TIR29:2012(R2017)

Guide for process characterization and control in radiation sterilization of medical devices
12/31/2012 - PDF - English - AAMI
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€251.00

AAMI EC57:2012 (R2020)

Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms
12/18/2012 - PDF - English - AAMI
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€220.00

AAMI/ISO TI(R1921)8-2:2012

Medical devices -Hierarchical coding structure for adverse events - Part 2: Evaluation codes
12/10/2012 - PDF - English - AAMI
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€132.00

ANSI/AAMI ST15883-3:2012/(R)2015 (R2023)

Washer-disinfectors -Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006, MOD)
12/3/2012 - PDF - English - AAMI
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€153.00

AAMI/ISO 25539-2:2012

Cardiovascular implants --Endovascular devices --Part 2: Vascular stents
12/3/2012 - PDF - English - AAMI
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€310.00

ANSI/AAMI ST15883-2:2013/(R)2015 (R2023)

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006, MOD)
12/3/2012 - PDF - English - AAMI
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€153.00