Category: AAMI

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

Sterilization Pt 1: Sterilization in Health Care Facilities
standard by Association for the Advancement of Medical Instrumentation, 2014

Chemical sterilization and high-level disinfection in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 08/21/2013

ECG TRUNK CABLES and PATIENT LEADWIRES
standard by Association for the Advancement of Medical Instrumentation, 11/19/2013

Guidance for the Validation and Routine Control of Industrial Ethylene Oxide Sterilization – Contract Sterilization
standard by Association for the Advancement of Medical Instrumentation, 02/24/1997

Medical electrical equipment – Part 2-20: Particular requirements for basic safety and essential performance of transport incubators
standard by Association for the Advancement of Medical Instrumentation, 12/09/2004

Transport Infant Incubators
standard by Association for the Advancement of Medical Instrumentation, 03/01/1997

Disposable ECG Electrodes
standard by Association for the Advancement of Medical Instrumentation, 05/03/2000

Dialysate for Hemodialysis (Includes A1:2007 and A2:2007)
standard by Association for the Advancement of Medical Instrumentation, 08/09/2004

Book by Association for the Advancement of Medical Instrumentation, 06/01/1995

Sterilization of health care products-Radiation sterilization-Product families, sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
standard by Association for the Advancement of Medical Instrumentation, 01/01/2001