Category: AAMI

Amendment 2, Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)Amendment by Association for the Advancement of Medical Instrumentation, 03/01/2022

Safety and effectiveness of health IT software and systems-Part 1: Fundamental concepts, principles, and requirementsstandard by Association for the Advancement of Medical Instrumentation, 03/01/2022

Flexible and semi-rigid endoscope processing in health care facilitiesstandard by Association for the Advancement of Medical Instrumentation, 12/21/2021

Fluid delivery performance testing for infusion pumpsstandard by Association for the Advancement of Medical Instrumentation, 10/15/2021

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

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method Vdmax SD-Sstandard by Association for the Advancement of Medical…

Ultrapure dialysis fluid for hemodialysis and related therapiesstandard 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 imagingstandard by Association for the Advancement of Medical Instrumentation,…

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

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