AAMI TIR34971:2023
Application of ISO 14971 to machine learning in artificial intelligence—Guide
standard by Association for the Advancement of Medical Instrumentation, 03/14/2023
AAMI 14117:2019
Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
standard by Association for the Advancement of Medical Instrumentation, 09/27/2019
AAMI TIR45:2023
Guidance on the use of agile practices in the development of medical device software
standard by Association for the Advancement of Medical Instrumentation, 03/15/2023
AAMI ST108:2023
Water for the processing of medical devices
standard by Association for the Advancement of Medical Instrumentation, 08/17/2023
AAMI SW96:2023
Standard for medical device security—Security risk management for device manufacturers
standard by Association for the Advancement of Medical Instrumentation, 12/21/2022
AAMI PB70:2022
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 12/05/2022
AAMI TIR 8-91
Microbiological Methods for Gamma Irradiation Sterilization of Medical Devices
standard by Association for the Advancement of Medical Instrumentation, 07/01/1991
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
AAMI TIR100: 2021
End-to-end microbiological quality and sterility assurance
standard by Association for the Advancement of Medical Instrumentation, 05/10/2022
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
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
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