Category: AAMI

Sterilization of health care products – Radiation – Substantiation of a selected sterilization dose at a specified sterility assurance level: Method Vdmax SD-S
standard by Association for the Advancement of Medical Instrumentation, 03/31/2021

Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
standard by Association for the Advancement of Medical Instrumentation, 09/24/2021

Ultrapure dialysis fluid for hemodialysis and related therapies
standard by Association for the Advancement of Medical Instrumentation, 02/26/2021

Active implantable medical devices – Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
standard by Association for the Advancement of Medical Instrumentation, 04/01/2021

Evaluation of particulate associated with vascular medical devices
standard by Association for the Advancement of Medical Instrumentation, 03/31/2021

Book by Association for the Advancement of Medical Instrumentation, 2021

Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
standard by Association for the Advancement of Medical Instrumentation, 09/17/2020

Risk management guidance for combination products
standard by Association for the Advancement of Medical Instrumentation, 09/10/2020

Recommended practices for a medical equipment management program
standard by Association for the Advancement of Medical Instrumentation, 03/13/2013

Book by Association for the Advancement of Medical Instrumentation, 07/01/1991

Book by Association for the Advancement of Medical Instrumentation, 06/01/1992

AAMI Standards and Recommended Practices – Volume 4: Biological Evaluation of Medical Devices
standard by Association for the Advancement of Medical Instrumentation, 04/01/1997