Category: AAMI

Microbiological Methods for Gamma Irradiation Sterilization of Medical Devices
standard by Association for the Advancement of Medical Instrumentation, 07/01/1991

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 logging
standard by Association for the Advancement of Medical Instrumentation, 04/22/2022

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

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

Standard for Interoperable Item Integration Life Cycle (ANSI/AAMI/UL 2800-1-3:2022)
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

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

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

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

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