Association for the Advancement of Medical Instrumentation (AAMI)

Association for the Advancement of Medical Instrumentation (AAMI)
AAMI (Association for the Advancement of Medical Instrumentation) is a non-profit organization that accredits manufacturers and suppliers of medical devices. Its accreditation program assesses compliance with quality and performance standards for medical devices. AAMI also provides guidelines and recommendations for the design, testing, and labeling of medical devices. By using AAMI-accredited devices, healthcare providers can ensure their patients receive safe and effective care.
ANSI/AAMI/ISO 10993-16:2020/(R)2022

ANSI/AAMI/ISO 10993-16:2020/(R)2022

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Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables

€144.00

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ANSI/AAMI/ISO 14155:2020

ANSI/AAMI/ISO 14155:2020

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Clinical investigation of medical devices for human subjects—Good clinical practice

€311.00

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AAMI/ISO TIR10993-19:2020

AAMI/ISO TIR10993-19:2020

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Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials

€178.00

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AAMI TIR97:2019/(R)2023

AAMI TIR97:2019/(R)2023

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Principles for medical device security—Postmarket risk management for device manufacturers

€268.00

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ANSI/AAMI ST72:2019

ANSI/AAMI ST72:2019

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Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing

€268.00

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ANSI/AAMI/ISO 11737-2:2019

ANSI/AAMI/ISO 11737-2:2019

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Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

€178.00

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AAMI HIT1000-3(PS):2019

AAMI HIT1000-3(PS):2019

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Safety and effectiveness of health IT software and systems—Part 3: Application of risk management

€21.00

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AAMI TIR102:2019

AAMI TIR102:2019

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U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems

€311.00

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AAMI TIR38:2019

AAMI TIR38:2019

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Medical device safety assurance case guidance

€268.00

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AAMI TIR75:2019

AAMI TIR75:2019

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Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples

€221.00

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ANSI/AAMI EQ93:2019/(R)2025

ANSI/AAMI EQ93:2019/(R)2025

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Medical equipment management—Vocabulary used in medical equipment programs

€126.00

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AAMI/ISO/IEC Guide 63:2019

AAMI/ISO/IEC Guide 63:2019

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Guide to the development and inclusion of aspects of safety in International Standards for medical devices

€213.00

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ANSI/AAMI 2700-1:2019

ANSI/AAMI 2700-1:2019

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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

€221.00

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ANSI/AAMI ST67:2019

ANSI/AAMI ST67:2019

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Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled —sterile—

€144.00

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ANSI/AAMI/ISO 14117:2019/(R)2025

ANSI/AAMI/ISO 14117:2019/(R)2025

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Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

€311.00

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