Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability
|Publication Date:||1 December 2006|
|ICS Code (Medical equipment):||11.040|
This International Standard specifies 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. This collateral standard addresses NORMAL USE and USE ERRORS but excludes ABNORMAL USE.