Category: AAMI

AAMI

Posted in AAMI

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

Posted in AAMI

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

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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

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AAMI ST108:2023

Water for the processing of medical devices
standard by Association for the Advancement of Medical Instrumentation, 08/17/2023

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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

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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

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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

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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

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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

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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