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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 TIR107-2026 PDF
The scope of this document is limited to implantable cardiac pacemakers, implantable devices intende..
AAMI TIR109-2025 PDF
This document provides guidance for health care facilities (see 3.9) and offsite reprocessing center..
AAMI TIR11-2005/(R)2026 PDF
This technical information report (TIR) covers the selection and use of protective apparel and surgi..
AAMI TIR115-2026 PDF
The purpose of this document is to provide guidance to multiple stakeholders on the appropriate use ..
AAMI TIR130-2025 PDF
This technical information report provides recommendations for the design of at-home diagnostic test..
AAMI TIR14-2016/(R)2024 PDF
This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 se..
AAMI TIR15-2016/(R)2024 PDF
AAMI TIR15:2016 provides additional guidance to augment ANSI/AAMI/ISO 11135:2014. This TIR addresses..
AAMI TIR16-2023/(R)2026 PDF
Addresses various microbiological aspects of the development and validation of an ethylene oxide ste..
AAMI TIR17-2024 PDF
This technical information report provides guidance for health care product manufacturers in the qua..
AAMI TIR18-2010 PDF
This AAMI Technical Information Report (TIR) provides information, guidance, and general recommendat..