Ultrapure dialysate for hemodialysis and related therapies
standard by Association for the Advancement of Medical Instrumentation, 09/23/2011
AAMI TIR38:2019
Medical device safety assurance case report guidance
standard by Association for the Advancement of Medical Instrumentation, 01/25/2019
AAMI TIR48:2015
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
AAMI TIR16:2000
Process development and performance qualification for ethylene oxide sterilization-Microbiological aspects
standard by Association for the Advancement of Medical Instrumentation, 03/13/2000
AAMI TIR29:2012/(R)2017
Guide for process characterization and control in radiation sterilization of medical devices
standard by Association for the Advancement of Medical Instrumentation, 12/31/2012
AAMI TIR35:2016
Sterilization of health care products – Radiation sterilization – Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
standard by Association for the Advancement of Medical Instrumentation, 06/05/2016
AAMI TIR50:2014/(R)2017
Post-market surveillance of use error management
standard by Association for the Advancement of Medical Instrumentation, 03/10/2014
AAMI TIR69:2017
Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
standard by Association for the Advancement of Medical Instrumentation, 04/28/2017