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Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
| 분야 | TC 62/SC 62D : Particular medical equipment, software, and systems |
|---|---|
| 적용범위 | 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. |
| 국제분류(ICS)코드 | 11.040.50 : 방사선 및 기타 진단 기기 |
| 페이지수 | 96 |
| Edition | 3.0 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-2-18:2009 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment | 2009-08-12 | 표준 |
| 2 | IEC 60601-2-18:1996/AMD1:2000 | Amendment 1 - Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment | 2000-07-13 | 구판 |
| 3 | IEC 60601-2-18:1996 | Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment | 1996-08-07 | 구판 |
| 4 | IEC 60601-2-18:1990 | Medical electrical equipment. Part 2: Particular requirements for the safety of endoscopic equipment. | 1990-09-05 | 구판 |
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