Category: AAMI
AAMI
Comprehensive guide to steam sterilization and sterility assurance in health care facilities (Consolidated Text)
standard by Association for the Advancement of Medical Instrumentation, 09/19/2011
Chemical sterilization and high-level disinfection in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 08/21/2013
Processing of health care products – Quality management systems for processing in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 07/18/2017
Validation of software for regulated processes
standard by Association for the Advancement of Medical Instrumentation, 12/13/2007
Process Challenge Devices/Test Packs for Use in Health Care Facilities
standard by Association for the Advancement of Medical Instrumentation, 11/20/2008
Sterilization Pt 1: Sterilization in Health Care Facilities
standard by Association for the Advancement of Medical Instrumentation, 2013
U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
standard by Association for the Advancement of Medical Instrumentation, 08/30/2019
Sustainability of medical devices–Elements of a responsible product life cycle
standard by Association for the Advancement of Medical Instrumentation, 2016