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

Active Most Recent

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

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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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

€205.00

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ANSI/AAMI EQ110:2024 Corrigendum 1

ANSI/AAMI EQ110:2024 Corrigendum 1

Active Most Recent

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

Active Most Recent

Microbiological methods—Understanding and use of product bioburden data

€221.00

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AAMI TIR48:2024

AAMI TIR48:2024

Active Most Recent

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

Active Most Recent

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

Active Most Recent

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

Active Most Recent

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

Active Most Recent

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

Active Most Recent

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

€221.00

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AAMI TIR45:2023

AAMI TIR45:2023

Active Most Recent

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

Active Most Recent

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

Active Most Recent

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

Active Most Recent

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

Active Most Recent

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

Active Most Recent

Water for the processing of medical devices

€311.00

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AAMI/ISO TIR21387:2023

AAMI/ISO TIR21387:2023

Active Most Recent

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

Active Most Recent

Microbiological aspects of ethylene oxide sterilization

€268.00

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ANSI/AAMI/ISO 13408-1:2023

ANSI/AAMI/ISO 13408-1:2023

Active Most Recent

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

€311.00

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ANSI/AAMI SW96:2023

ANSI/AAMI SW96:2023

Active Most Recent

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

€268.00

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AAMI TIR104:2022

AAMI TIR104:2022

Active Most Recent

Guidance on transferring health care products between radiation sterilization sources

€221.00

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ANSI/AAMI ST98:2022

ANSI/AAMI ST98:2022

Active Most Recent

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

Active Most Recent

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

Active Most Recent

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

Active Most Recent

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

Active Most Recent

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

Active Most Recent

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

Active Most Recent

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

Active Most Recent

Standard for Medical Device Interoperability

€311.00

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ANSI/AAMI/ISO 18472:2022

ANSI/AAMI/ISO 18472:2022

Active Most Recent

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

Active Most Recent

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

€311.00

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ANSI/AAMI/ISO 5840-2:2022

ANSI/AAMI/ISO 5840-2:2022

Active Most Recent

Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes

€268.00

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ANSI/AAMI/ISO 5840-3:2022

ANSI/AAMI/ISO 5840-3:2022

Active Most Recent

Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques

€268.00

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ANSI/AAMI/ISO 15223-1:2022

ANSI/AAMI/ISO 15223-1:2022

Active Most Recent

Medical devices—Symbols to be used with information to be supplied by the manufacturer— Part 1: General requirements

€251.00

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AAMI/ISO TIR22456:2022

AAMI/ISO TIR22456:2022

Active Most Recent

Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products

€178.00

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ANSI/AAMI PB70:2022 Redline

ANSI/AAMI PB70:2022 Redline

Active Most Recent

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

€268.00

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ANSI/AAMI/ISO 17664-1:2022

ANSI/AAMI/ISO 17664-1:2022

Active Most Recent

Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices

€221.00

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ANSI/AAMI/ISO 17664-2:2022

ANSI/AAMI/ISO 17664-2:2022

Active Most Recent

Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices

€221.00

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ANSI/AAMI PB70:2022

ANSI/AAMI PB70:2022

Active Most Recent

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

€268.00

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ANSI/AAMI/ISO 13004:2022

ANSI/AAMI/ISO 13004:2022

Active Most Recent

Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD

€268.00

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AAMI TIR42:2021

AAMI TIR42:2021

Active Most Recent

Evaluation of particulate associated with vascular medical devices

€251.00

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AAMI CR510:2021

AAMI CR510:2021

Active Most Recent

Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices

€126.00

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AAMI TIR101:2021

AAMI TIR101:2021

Active Most Recent

Fluid delivery performance testing for infusion pumps

€268.00

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ANSI/AAMI CN27:2021

ANSI/AAMI CN27:2021

Active Most Recent

General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications

€221.00

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AAMI TIR58:2021/(R)2025

AAMI TIR58:2021/(R)2025

Active Most Recent

Water testing methodologies

€251.00

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ANSI/AAMI ST91:2021

ANSI/AAMI ST91:2021

Active Most Recent

Flexible and semi-rigid endoscope processing in health care facilities

€362.00

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