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 TIR109:2025

AAMI TIR109:2025

Active Most Recent

External transport of reusable medical devices for processing

€221.00

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AAMI CR515:2025

AAMI CR515:2025

Active Most Recent

Cybersecurity considerations unique to machine learning–enabled medical devices

€178.00

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ANSI/AAMI HE75:2025

ANSI/AAMI HE75:2025

Active Most Recent

Human factors engineering—Design of medical devices

€706.00

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AAMI TIR130:2025

AAMI TIR130:2025

Active Most Recent

Best practices for designing accessible at-home diagnostic test kits

€311.00

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ANSI/AAMI/ISO 11140-6:2024

ANSI/AAMI/ISO 11140-6:2024

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Sterilization of health care products—Chemical indicators—Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers

€268.00

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AAMI TIR106:2024

AAMI TIR106:2024

Active Most Recent

Microbiological methods—Understanding and use of product bioburden data

€221.00

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AAMI TIR48:2024

AAMI TIR48:2024

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Quality Management System (QMS) guidance on compliance with FDA's Final Rule on combination products

€251.00

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AAMI TIR99:2024

AAMI TIR99:2024

Active Most Recent

Processing of dilators, transesophageal and ultrasound probes in health care facilities

€268.00

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ANSI/AAMI ST24:2024

ANSI/AAMI ST24:2024

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General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities

€221.00

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ANSI/AAMI ST58:2024

ANSI/AAMI ST58:2024

Active Most Recent

Chemical sterilization and high-level disinfection in health care facilities

€373.00

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AAMI CR513:2024

AAMI CR513:2024

Active Most Recent

Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing

€144.00

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ANSI/AAMI EQ56:2024

ANSI/AAMI EQ56:2024

Active Most Recent

Standard for a medical equipment management program

€251.00

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ANSI/AAMI EQ103:2024

ANSI/AAMI EQ103:2024

Active Most Recent

Alternate equipment management (AEM) program in healthcare delivery organizations (HDOs)

€221.00

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ANSI/AAMI EQ110:2024

ANSI/AAMI EQ110:2024

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Healthcare technology management (HTM) educational programs

€144.00

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AAMI TIR17:2024

AAMI TIR17:2024

Active Most Recent

Compatibility of materials subject to sterilization

€311.00

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