Category: AAMI

AAMI

AAMI ST8:2013/(R)2018

Hospital steam sterilizersstandard by Association for the Advancement of Medical Instrumentation, 04/25/2013

AAMI TIR24:1999/(R)2019

Acquisition and use of physiologic waveform databases for testing of medical devicesstandard by Association for the Advancement of Medical Instrumentation, 08/18/1999

AAMI TIR36:2007

Validation of software for regulated processesstandard by Association for the Advancement of Medical Instrumentation, 12/13/2007

AAMI STBK13-2

AAMI Standards and Recommended Practices - Sterilization, Part 2: Sterilization Equipment, 2013 Editionstandard by Association for the Advancement of Medical Instrumentation, 2013

AAMI TIR59:2017

Integrating human factors into design controlsstandard by Association for the Advancement of Medical Instrumentation, 08/04/2017

AAMI TIR102:2019

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systemsstandard by Association for the Advancement of Medical Instrumentation, 08/30/2019

AAMI ES60601-1:2005/(R)2012

Medical electrical equipment-Part 1: General requirements for basic safety and essential performance, Consolidated Textstandard by Association for the Advancement of Medical Instrumentation, 02/09/2006

AAMI TIR67:2018

Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilitiesstandard by Association for the Advancement of Medical Instrumentation, 04/25/2018

AAMI TIR61:2014/(R)2019

Generating reports for human factors design validation results for external cardiac defibrillatorsstandard by Association for the Advancement of Medical Instrumentation, 10/24/2014

AAMI TIR60:2014/(R)2019

Common mode rejection in ECG monitoringstandard by Association for the Advancement of Medical Instrumentation, 10/24/2014