标准号:ANSI/AAMI/IEC 62366-2007
中文标准名称:医疗设备.医疗设备易用性工程应用件
英文标准名称:Medical devices - Application of usability engineering to medical devices
标准类型:C30
发布日期:1999/12/31 12:00:00
实施日期:1999/12/31 12:00:00
中国标准分类号:C30
国际标准分类号:11.040.01
适用范围:This standard describes a usability engineering process, and provides guidance on how to implement and execute the process to provide safety in medical devices. It is intended to be useful not only for manufacturers of medical devices, but also for technical committees responsible for the preparation of particular medical device standards.