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/ISO TIR21387:2023

AAMI/ISO TIR21387:2023

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Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release

€178.00

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AAMI TIR16:2023

AAMI TIR16:2023

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Microbiological aspects of ethylene oxide sterilization

€268.00

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ANSI/AAMI/ISO 13408-1:2023

ANSI/AAMI/ISO 13408-1:2023

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Aseptic processing of health care products—Part 1: General requirements

€311.00

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ANSI/AAMI SW96:2023

ANSI/AAMI SW96:2023

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Standard for medical device security—Security risk management for device manufacturers

€268.00

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AAMI TIR104:2022

AAMI TIR104:2022

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Guidance on transferring health care products between radiation sterilization sources

€221.00

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ANSI/AAMI ST98:2022

ANSI/AAMI ST98:2022

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Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices

€251.00

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AAMI/ISO TIR11137-4:2022/(R)2023

AAMI/ISO TIR11137-4:2022/(R)2023

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Sterilization of health care products—Radiation—Part 4: Guidance on process control

€268.00

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ANSI/AAMI HIT1000-1:2022

ANSI/AAMI HIT1000-1:2022

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Safety and effectiveness of health IT software and systems—Part 1: Fundamental concepts, principles, and requirements

€251.00

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ANSI/AAMI 2700-2-1:2022

ANSI/AAMI 2700-2-1:2022

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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 2-1: Particular requirements for forensic data logging

€251.00

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ANSI/AAMI/UL 2800-1-1:2022

ANSI/AAMI/UL 2800-1-1:2022

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Standard for Risk Concerns for Interoperable Medical Products

€268.00

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ANSI/AAMI/UL 2800-1-2:2022

ANSI/AAMI/UL 2800-1-2:2022

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Standard for Interoperable Item Development Life Cycle

€251.00

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ANSI/AAMI/UL 2800-1-3:2022

ANSI/AAMI/UL 2800-1-3:2022

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Standard for Interoperable Item Integration Life Cycle

€221.00

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ANSI/AAMI/UL 2800-1:2022

ANSI/AAMI/UL 2800-1:2022

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Standard for Medical Device Interoperability

€311.00

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ANSI/AAMI/ISO 18472:2022

ANSI/AAMI/ISO 18472:2022

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Sterilization of health care products—Biological and chemical indicators—Test equipment

€251.00

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ANSI/AAMI/ISO 5840-1:2022

ANSI/AAMI/ISO 5840-1:2022

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Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements

€311.00

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