Analysis and Discussion on Standard Requirements of YY/T 9706.106-2021 Medical Electrical Equipment—Part 1-6:General Requirements for Basic Safety and Essential Performance—Collateral Standard:Usability
YY/T 9706.106-2021 sets requirements for manufacturers to analyse,specify,design,verify and validate usability related to basic safety and basic performance of medical electrical equipment.This paper deeply analyzes the common problems found in usability engineering documents during testing and their causes,and introduces the requirements and contents of standards.The purpose of this paper is to help manufacturers better understand and apply the standards,and to provide guidance for manufacturers to provide correct and complete usability engineering documentation,hoping to promote the high-quality development of medical device usability.
medical devicemedical electrical equipmentusability engineering documentationhuman factor engineeringstandard
万方数据
维普
