AAMI
AAMI CR34971:2022
- May
- 04

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
AAMI HIT1000-1: 2022
- May
- 04

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 ES60601-1: 2005/A2:2021
- May
- 04

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
AAMI HA60601-1-11:2015/A1:2021
- May
- 04

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
AAMI TIR58:2021
- May
- 04

Water testing methodologies
standard by Association for the Advancement of Medical Instrumentation, 12/21/2021
AAMI TIR104:2022
- May
- 04

Guidance on transferring health care products between radiation sterilization sources
standard by Association for the Advancement of Medical Instrumentation, 04/19/2022
AAMI ST91:2021
- May
- 04

Flexible and semi-rigid endoscope processing in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 12/21/2021
AAMI TIR76:2021
- Nov
- 23

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 CR510:2021
- Nov
- 23

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 ST44 : 2002
- Nov
- 23

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