医用电气设备.安全性详细要求.γ射线束治疗设备规范

标准编号：BS EN 60601-2-11-1998

提出单位：BSI

起草单位：BSI

发布日期：1998年

实施日期：19980415

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中国标准分类号：C43

国际标准分类号：11_040_50

摘      要：Addition: aa) This Particular Standard specifies requirements for the safety of GAMMA BEAM THERAPY EQUIPMENT intended for RADIOTHERAPY in human medical practice and includes EQUIPMENT in which the selection and DISPLAY of operating parameters can be controlled by a PROGRAMMABLE ELECTRONIC SYSTEM (PES). bb) This Particular Standard applies to EQUIPMENT which is intended to deliver a GAMMA RADIATION BEAM(S) at NORMAL TREATMENT DISTANCES greater than 5 cm using a SEALED RADIOACTIVE SOURCE(S). For EQUIPMENT operating at shorter distances, special precautions may be necessary. cc) This Particular Standard applies to EQUIPMENT intended to be: - used under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS having the skills required for a particular medical application and acting in accordance with the INSTRUCTIONS FOR USE, - maintained at predetermined intervals, - subject to regular checks by the USER, - used for particular specified clinical purposes e.g. STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY. dd) This Particular Standard is applicable to the manufacture and some installation aspects of GAMMA BEAM THERAPY EQUIPMENT by the inclusion of TYPE TESTS and SITE TESTS respectively. ee) This Particular Standard specifies the requirements for EQUIPMENT. It does not specify the requirements for the RADIATION SOURCES.