Category: AAMI

AAMI

Posted in AAMI

AAMI TIR58:2021

Water testing methodologies
standard by Association for the Advancement of Medical Instrumentation, 12/21/2021

Posted in AAMI

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

Posted in AAMI

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

Posted in AAMI

AAMI HIT1000-1: 2022

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

Posted in AAMI

AAMI ST91:2021

Flexible and semi-rigid endoscope processing in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 12/21/2021

Posted in AAMI

AAMI ES60601-1: 2005/A2:2021

Amendment 2, Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
Amendment by Association for the Advancement of Medical Instrumentation, 03/01/2022

Posted in AAMI

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

Posted in AAMI

AAMI TIR 101:2021

Fluid delivery performance testing for infusion pumps
standard by Association for the Advancement of Medical Instrumentation, 10/15/2021

Posted in AAMI

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

Posted in AAMI

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

Posted in AAMI

AAMI TIR43:2021

Ultrapure dialysis fluid for hemodialysis and related therapies
standard by Association for the Advancement of Medical Instrumentation, 02/26/2021

Posted in AAMI

AAMI PC76:2021

Active implantable medical devices – Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
standard by Association for the Advancement of Medical Instrumentation, 04/01/2021