Category: AAMI

Water for the processing of medical devices
standard by Association for the Advancement of Medical Instrumentation, 08/17/2023

Guidance on the use of agile practices in the development of medical device software
standard by Association for the Advancement of Medical Instrumentation, 03/15/2023

Standard for medical device security—Security risk management for device manufacturers
standard by Association for the Advancement of Medical Instrumentation, 12/21/2022

Application of ISO 14971 to machine learning in artificial intelligence—Guide
standard by Association for the Advancement of Medical Instrumentation, 03/14/2023

Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
standard by Association for the Advancement of Medical Instrumentation, 09/27/2019

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 12/05/2022

Microbiological Methods for Gamma Irradiation Sterilization of Medical Devices
standard by Association for the Advancement of Medical Instrumentation, 07/01/1991

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

Standard for Interoperable Item Development Life Cycle (ANSI/AAMI/UL 2800-1-2:2022)
standard by Association for the Advancement of Medical Instrumentation, 06/10/2022

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