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
AAMI CR34971:2022
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
AAMI TIR104:2022
Guidance on transferring health care products between radiation sterilization sources
standard by Association for the Advancement of Medical Instrumentation, 04/19/2022
AAMI TIR43:2021
Ultrapure dialysis fluid for hemodialysis and related therapies
standard by Association for the Advancement of Medical Instrumentation, 02/26/2021
AAMI ST44 : 2002
Resistometers used for characterizing the performance of biological and chemical indicators
standard by Association for the Advancement of Medical Instrumentation,
AAMI TIR 101:2021
Fluid delivery performance testing for infusion pumps
standard by Association for the Advancement of Medical Instrumentation, 10/15/2021
AAMI TIR76:2021
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
AAMI CR510:2021
Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
standard by Association for the Advancement of Medical Instrumentation, 09/24/2021
AAMI TIR42:2021
Evaluation of particulate associated with vascular medical devices
standard by Association for the Advancement of Medical Instrumentation, 03/31/2021
Basic Concepts in Validation and Qualification of Cleaning and Sterilization Processes for Reusable Medical Devices
Book by Association for the Advancement of Medical Instrumentation, 2021