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

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

  • by admin
  • Comments Off on AAMI HA60601-1-11:2015/A1:2021
  • 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

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

AAMI TIR43:2021

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

AAMI ST44 : 2002

Resistometers used for characterizing the performance of biological and chemical indicators
standard by Association for the Advancement of Medical Instrumentation,

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

AAMI TIR 101:2021

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

AAMI TIR12:2020

Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
standard by Association for the Advancement of Medical Instrumentation, 09/17/2020

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