Category: AAMI

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

Amendment 1, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015, MOD)
Amendment by Association for the Advancement of Medical Instrumentation, 03/20/2022

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

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

Guidance on transferring health care products between radiation sterilization sources
standard by Association for the Advancement of Medical Instrumentation, 04/19/2022

Water testing methodologies
standard by Association for the Advancement of Medical Instrumentation, 12/21/2021

Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
standard by Association for the Advancement of Medical Instrumentation, 04/01/2022

Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
standard 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-S
standard by Association for the Advancement of Medical Instrumentation, 03/31/2021

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