IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability
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IEC 60601-1-6 Document Information:
Title
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability
Appareils électromédicaux – Partie 1-6: Exigences générales pour la sécurité de base et les performances essentielles Norme collatérale: Aptitude à l’utilisation
International Electrotechnical Commission
Publication Date:
Dec 1, 2006
Scope:
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.
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