Category: AAMI

Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
standard by Association for the Advancement of Medical Instrumentation, 02/28/2017

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

Human factors engineering for processing medical devices
standard by Association for the Advancement of Medical Instrumentation, 12/23/2014

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
standard by Association for the Advancement of Medical Instrumentation, 01/06/2017

Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
standard by Association for the Advancement of Medical Instrumentation, 06/01/2019

Biological evaluation of medical devices – Part 18: Chemical characterization of materials
standard by Association for the Advancement of Medical Instrumentation, 03/21/2006

Principles for medical device security – Postmarket risk management for device manufacturers
standard by Association for the Advancement of Medical Instrumentation, 09/27/2019

Water testing methodologies
standard by Association for the Advancement of Medical Instrumentation, 09/22/2014

Handbook / Manual / Guide by Association for the Advancement of Medical Instrumentation, 08/27/2004

Sterilization of health care products – Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
standard by Association for the Advancement of Medical Instrumentation, 07/29/2019