Category: AAMI

AAMI

Posted in AAMI

AAMI 2800-1-3:2022

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

Posted in AAMI

AAMI ES60601-1: 2005 & A1:2012 & A2:2021

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

Posted in AAMI

AAMI 2800-1:2022

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

Posted in AAMI

AAMI 2800-1-1:2022

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

Posted in AAMI

AAMI ST98:2022

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

Posted in AAMI

AAMI 2800-1-2:2022

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

Posted in AAMI

AAMI 2700-2-1: 2022

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

Posted in AAMI

AAMI TIR100: 2021

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

Posted in AAMI

AAMI HA60601-1-11:2015 & A1:2021

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

Posted in AAMI

AAMI TIR58:2021

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

Posted in AAMI

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

Posted in AAMI

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