PDF Standards AAMI TIR36:2007
Validation of software for regulated processes
standard by Association for the Advancement of Medical Instrumentation, 12/13/2007
Validation of software for regulated processes
standard by Association for the Advancement of Medical Instrumentation, 12/13/2007
Book by Association for the Advancement of Medical Instrumentation, 06/01/1995
Application of quality management system concepts to medical device data systems
standard by Association for the Advancement of Medical Instrumentation, 05/23/2012
Human factors engineering for processing medical devices
standard by Association for the Advancement of Medical Instrumentation, 12/23/2014
Compatibility of materials subject to sterilization
standard by Association for the Advancement of Medical Instrumentation, 06/11/2017
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
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
Medical electrical equipment, Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
standard by Association for the Advancement of Medical Instrumentation, 02/09/2006
Active implantable medical devices – Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
standard by Association for the Advancement of Medical Instrumentation, 11/30/2011
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
standard by Association for the Advancement of Medical Instrumentation, 09/17/2020