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 TIR107:2026

AAMI TIR107:2026

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Cardiovascular implantable electronic devices—Battery longevity management and reporting and prolonged service period behavior

€144.00

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ANSI/AAMI HE75:2025

ANSI/AAMI HE75:2025

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Human factors engineering—Design of medical devices

€706.00

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AAMI TIR130:2025

AAMI TIR130:2025

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Best practices for designing accessible at-home diagnostic test kits

€311.00

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AAMI TIR109:2025

AAMI TIR109:2025

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External transport of reusable medical devices for processing

€221.00

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AAMI CR515:2025

AAMI CR515:2025

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Cybersecurity considerations unique to machine learning–enabled medical devices

€205.00

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ANSI/AAMI EQ110:2024 Corrigendum 1

ANSI/AAMI EQ110:2024 Corrigendum 1

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Healthcare technology management (HTM) educational programs Corrigendum 1

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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

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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

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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

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Chemical sterilization and high-level disinfection in health care facilities

€373.00

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AAMI CR513:2024

AAMI CR513:2024

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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

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Standard for a medical equipment management program

€251.00

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ANSI/AAMI EQ103:2024

ANSI/AAMI EQ103:2024

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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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ANSI/AAMI/IEC 80601-2-58:2024

ANSI/AAMI/IEC 80601-2-58:2024

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Medical electrical equipment—Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

€334.00

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AAMI TIR17:2024

AAMI TIR17:2024

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Compatibility of materials subject to sterilization

€311.00

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ANSI/AAMI/ISO 23500-1:2024

ANSI/AAMI/ISO 23500-1:2024

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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 23500-2:2024

ANSI/AAMI/ISO 23500-2:2024

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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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ANSI/AAMI/ISO 23500-3:2024

ANSI/AAMI/ISO 23500-3:2024

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Preparation and quality management of fluids for haemodialysis and related therapies—Part 3: Water for haemodialysis and related therapies

€178.00

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ANSI/AAMI/ISO 23500-4:2024

ANSI/AAMI/ISO 23500-4:2024

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Preparation and quality management of fluids for haemodialysis and related therapies—Part 4: Concentrates for haemodialysis and related therapies

€221.00

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ANSI/AAMI/ISO 23500-5:2024

ANSI/AAMI/ISO 23500-5:2024

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Preparation and quality management of fluids for haemodialysis and related therapies—Part 5: Quality of dialysis fluid for haemodialysis and related therapies

€178.00

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AAMI TIR34971:2023

AAMI TIR34971:2023

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Application of ISO 14971 to machine learning in artificial intelligence—Guide

€221.00

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AAMI TIR45:2023

AAMI TIR45:2023

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Guidance on the use of AGILE practices in the development of medical device software

€311.00

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ANSI/AAMI/ISO 10993-13-2010/(R)2019:2023

ANSI/AAMI/ISO 10993-13-2010/(R)2019:2023

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Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices

€129.00

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AAMI TIR45:2023 Redline

AAMI TIR45:2023 Redline

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Guidance on the use of AGILE practices in the development of medical device software

€311.00

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ANSI/AAMI/ISO 11138-8:2023

ANSI/AAMI/ISO 11138-8:2023

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Sterilization of health care products—Biological indicators—Part 8: Method for validation of a reduced incubation item for a biological indicator

€144.00

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AAMI/ISO TIR16775:2023

AAMI/ISO TIR16775:2023

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Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2

€373.00

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ANSI/AAMI ST108:2023

ANSI/AAMI ST108:2023

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Water for the processing of medical devices

€311.00

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