Category: AAMI

Transcutaneous Electrical Nerve Stimulators
standard by Association for the Advancement of Medical Instrumentation, 03/20/2013

Classification of defects in health software
standard by Association for the Advancement of Medical Instrumentation, 11/02/2018

Post-market surveillance of use error management
standard by Association for the Advancement of Medical Instrumentation, 03/10/2014

Processing of Reusable Surgical Textiles for Use in Health Care Facilities
standard by Association for the Advancement of Medical Instrumentation,

Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
standard by Association for the Advancement of Medical Instrumentation, 03/28/2005

Technical Information Report: Process Challenge Devices/Test Packs for Use in Health Care Facilities
standard by Association for the Advancement of Medical Instrumentation, 03/14/2003

Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
standard by Association for the Advancement of Medical Instrumentation, 03/24/2020

Guidance for the use of medical equipment maintenance strategies and procedures
standard by Association for the Advancement of Medical Instrumentation, 02/06/2015

Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
standard by Association for the Advancement of Medical Instrumentation, 02/28/2017

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
standard by Association for the Advancement of Medical Instrumentation, 08/14/2015

Cardiac Defibrillator Devices
standard by Association for the Advancement of Medical Instrumentation, 04/01/1996

Microbiological aspects of ethylene oxide sterilization
standard by Association for the Advancement of Medical Instrumentation, 03/03/2010