60601-2-43-2000

Medical Electrical Equipment - Part 2-43: Particular Requirements for the Safety of X-Ray Equipment for Interventional Procedures (Edition 1.0)


 

 

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标准号
60601-2-43-2000
发布日期
2000年06月01日
实施日期
2010年04月07日
废止日期
中国标准分类号
/
国际标准分类号
/
发布单位
IEC - International Electrotechnical Commission
引用标准
42
适用范围
Addition: This Particular Standard applies to X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES. Its scope excludes@ in particular: ?C equipment for RADIOTHERAPY; ?C equipment for COMPUTED TOMOGRAPHY; ?C ACCESSORIES intended to be introduced into the PATIENT; ?C mammographic X-RAY EQUIPMENT. NOTE 1? Examples of prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES@ for which the use of EQUIPMENT complying with this standard is recommended@ are given in annex BB. NOTE 2? The particular requirements of this standard are not essential for EQUIPMENT used in all RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES. Examples of procedures@ for which the use of EQUIPMENT complying with this standard is considered not to be essential@ are given in annex BB. EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES@ which does not include a PATIENT SUPPORT as part of the system@ is exempt from the PATIENT SUPPORT provisions of this standard. ?




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