
Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability
出版:Nederlands Normalisatie Instituut

专家解读视频
Defines requirements for a PROCESS to analyse, design, verify and validate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. It also addresses NORMAL USE and USE ERRORS but excludes ABNORMAL USE.
IEC 60601-1-6 Ed. 2.0 - Identical