Category: AAMI

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…

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 loggingstandard by Association for the…

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 Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2022)standard by Association for the Advancement of Medical Instrumentation, 06/10/2022

End-to-end microbiological quality and sterility assurancestandard by Association for the Advancement of Medical Instrumentation, 05/10/2022

Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devicesstandard by Association for the Advancement of Medical Instrumentation, 08/22/2022

Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learningstandard by Association for the Advancement of Medical Instrumentation, 04/01/2022

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…

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

Guidance on transferring health care products between radiation sterilization sourcesstandard by Association for the Advancement of Medical Instrumentation, 04/19/2022