Category: AAMI

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

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

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

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

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

Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) CONSOLIDATED EDITION
standard by Association for the Advancement of Medical Instrumentation, 08/22/2022

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 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

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