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AAMI-Association for the Advancement of Medical Instrumentation
Essential AAMI Standards & Medical Device Guidelines
The Association for the Advancement of Medical Instrumentation (AAMI) sets the benchmark for national and international safety standards across the medical device industry. Designed to support biomedical engineers, clinical technicians, and infection prevention specialists, AAMI publications deliver practical insights for operational compliance and equipment maintenance.
Explore our complete library of ANSI/AAMI standards, practical guidebooks, and training resources covering steam sterilization, biomedical equipment management, and healthcare technology safety protocols.
AAMI TIR20-2001 PDF
This AAMI technical information report (TIR) provides guidance to augment information and requiremen..
AAMI TIR21-2017/(R)2025 PDF
Discusses clinical expectations for performance of systems used to develop better tools to forecast ..
AAMI TIR23-1999/(R)2019 PDF
The signal-averaged electrocardiogram (SAECG) facilitates noninvasive recording of low-amplitude car..
AAMI TIR24-1999/(R)2025 PDF
This report covers the nomenclature, ingredients, and principles needed to develop, annotate, evalua..
AAMI TIR28-2016/(R)2024 PDF
This technical information report provides guidance for the adoption of new or modified products int..
AAMI TIR29-2012/(R)2017 PDF
This technical information report provides additional guidance for characterizing the irradiation pr..
AAMI TIR31-2008 PDF
This technical information report provides information that will assist health care facilities in th..
AAMI TIR34971-2023 PDF
This document provides guidance and intends to serve as a companion to ANSI/AAMI/ISO 14971:2019 for ..
AAMI TIR35-2016 (R2021) PDF
Describes approaches to the selection and auditing of a sterilization dose that may reduce the numbe..
AAMI TIR36-2007 PDF
Applies to any software used to automate device design, testing, component acceptance, manufacturing..