Medical electrical equipment – Part 1-6: General requirements for safety – Collateral Standard: Usability
|Publication Date:||1 June 2004|
|ICS Code (Medical equipment):||11.040|
This Collateral Standard specifies requirements for a PROCESS to analyse, design, verify and validate the USABILITY, as it relates to SAFETY of MEDICAL ELECTRICAL EQUIPMENT, hereinafter referred to as EQUIPMENT. This standard addresses NORMAL USE and USE ERRORS but excludes ABNORMAL USE.