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
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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 HA60601-1-11:2015/A1:2021
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 TIR 101:2021
Fluid delivery performance testing for infusion pumps
standard by Association for the Advancement of Medical Instrumentation, 10/15/2021
AAMI TIR43:2021
Ultrapure dialysis fluid for hemodialysis and related therapies
standard by Association for the Advancement of Medical Instrumentation, 02/26/2021
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 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 ST44 : 2002
Resistometers used for characterizing the performance of biological and chemical indicators
standard by Association for the Advancement of Medical Instrumentation,
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
AAMI TIR12:2020
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