Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: EN 60601-1-6:2010
• Năm ban hành / Publication date: 2010
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: UsabilityIEC 60601-1-6:2010
• Phạm vi áp dụng / Scope of standard: This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE.