Category: AAMI

AAMI

AAMI TIR34971:2023

AAMI TIR34971:2023

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

AAMI TIR45:2023

AAMI TIR45:2023

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

AAMI SW96:2023

AAMI SW96:2023

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

AAMI 14117:2019

AAMI 14117:2019

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

AAMI ST108:2023

AAMI ST108:2023

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

AAMI PB70:2022

AAMI PB70:2022

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

AAMI TIR 8-91

AAMI TIR 8-91

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

AAMI 2700-2-1: 2022

AAMI 2700-2-1: 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

AAMI 2800-1-3:2022

AAMI 2800-1-3:2022

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

AAMI 2800-1:2022

AAMI 2800-1:2022

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