Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: EN 60601-1-4:1996
• Năm ban hành / Publication date: 1996
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systemsIEC 60601-1-4:1996
• Phạm vi áp dụng / Scope of standard: IEC 60601-2-18:2009 establishes particular basic safety and essential performance requirements for endoscopic equipment. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of endoscopic equipment. IEC 60601-2-18:2009 amends and supplements IEC 60601-1:2005. This third edition cancels and replaces the second edition, published in 1996, and its Amendment 1 (2000). This edition constitutes a technical revision and has been aligned or harmonized with IEC 60601-1:2005. The main changes with respect to the previous edition include: - alignment of requirements with IEC 60601-1:2005; - inclusion of essential performance requirements; - the inclusion of energized endoscopes and energized endotherapy devices used through second and subsequent punctures within the scope of the standard; - reference to IEC 60601-2-2 for the dielectric strength testing of HF energized endotherapy devices, rather than defining different tests.