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.
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 11138-7:2019

ANSI/AAMI/ISO 11138-7:2019

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Sterilization of health care products—Biological indicators—Part 7: Guidance for the selection, use and interpretation of results

€268.00

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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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ANSI/AAMI/ISO 11607-1:2019

ANSI/AAMI/ISO 11607-1:2019

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Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems

€251.00

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ANSI/AAMI/ISO 11607-2:2019

ANSI/AAMI/ISO 11607-2:2019

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Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes

€174.00

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ANSI/AAMI/ISO 14971:2019

ANSI/AAMI/ISO 14971:2019

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Medical devices—Application of risk management to medical devices

€268.00

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ANSI/AAMI/ISO 23500-1:2019

ANSI/AAMI/ISO 23500-1:2019

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Preparation and quality management of fluids for haemodialysis and related therapies—Part 1: General requirements

€311.00

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ANSI/AAMI/ISO 23500-2:2019

ANSI/AAMI/ISO 23500-2:2019

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Preparation and quality management of fluids for haemodialysis and related therapies—Part 2: Water treatment equipment for haemodialysis applications and related therapies

€251.00

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