Category: AAMI
AAMI
End-to-end microbiological quality and sterility assurance
standard by Association for the Advancement of Medical Instrumentation, 05/10/2022
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
Standard for Interoperable Item Development Life Cycle (ANSI/AAMI/UL 2800-1-2:2022)
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
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) CONSOLIDATED EDITION
standard by Association for the Advancement of Medical Instrumentation, 08/22/2022
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
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
Water testing methodologies
standard by Association for the Advancement of Medical Instrumentation, 12/21/2021
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
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