Category: AAMI

Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD), Consolidated Text of ES60601-1:2005/(R)2012 and A1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012standard by Association for the…

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

Change summary for ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devicesstandard by…

Dialysate for hemodialysis (consolidated text with Amendments 1 through 4 included)standard by Association for the Advancement of Medical Instrumentation, 05/01/2009

AAMI Standards and Recommended Practices - Volume 2.2 - Biomedical Equipment, Part 2: Monitoring and Diagnostic Equipmentstandard by Association for the Advancement of Medical Instrumentation, 12/01/1995

Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devicesstandard by Association for the Advancement of Medical Instrumentation, 09/03/2009

Product adoption and process equivalency for ethylene oxide sterilizationstandard by Association for the Advancement of Medical Instrumentation, 11/18/2016

Systems Used to Forecast Remaining Pacemaker Battery Service Lifestandard by Association for the Advancement of Medical Instrumentation, 06/11/2017

AAMI Standards and Recommended Practices - Part 1:Sterilization in Health Care Facilitiesstandard by Association for the Advancement of Medical Instrumentation, 09/01/2000

Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testingstandard by Association for the Advancement of Medical Instrumentation, 12/22/2011