Category: AAMI

Cleaning validation of health care products – Requirements for development and validation of a cleaning process for medical devices
standard by Association for the Advancement of Medical Instrumentation, 08/22/2022

Medical devices and medical systems-Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging
standard by Association for the Advancement of Medical Instrumentation, 04/22/2022

End-to-end microbiological quality and sterility assurance
standard by Association for the Advancement of Medical Instrumentation, 05/10/2022

Standard for Risk Concerns for Interoperable Medical Products (ANSI/AAMI/UL 2800-1-1:2022)
standard by Association for the Advancement of Medical Instrumentation, 06/10/2022

Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2022)
standard by Association for the Advancement of Medical Instrumentation, 06/10/2022

Standard for Interoperable Item Integration Life Cycle (ANSI/AAMI/UL 2800-1-3:2022)
standard by Association for the Advancement of Medical Instrumentation, 06/10/2022

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

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

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