AAMI TIR55:2014/(R)2017

Human factors engineering plays a significant role in the successful processing of medical devices. The objective of this TIR is to provide guidance to medical device manufacturers from a human factors perspective on the aspects of product design; design of processing instructions for use (IFU); education and training design; and development, verification, and validation of the device processing process to meet the needs of personnel working in a health care facility processing environment. No annex