适用于人类医疗实践中用于放射治疗的记录和验证系统（RVS）的设计、制造和某些安装方面 a） 提供、定义或显示治疗机设置数据；通过操作员输入或直接从其他设备输入数据， b） 可控制该设备的运行能力； c） 记录所有治疗疗程的数据；和 d） 旨在: 1） 在适当许可或合格人员的授权下，由具有所需技能和培训的操作员正常使用； 2） 按照使用说明中给出的建议进行维护；和 3） 在技术说明中规定的环境和供电条件下使用。

Applies to the design and manufacture and some installation aspects of a record and verify system (RVS) for use in radiotherapy in human medical practice that a) provides, defines, or displays treatment machine set up data; imports data either through input by the operator or directly from other devices, b) may control the ability of that equipment to operate; c) records data of all treatment sessions; and d) is intended to be: 1) for normal use, under the authority of appropriately licensed or qualified persons, by operators having the required skills and training; 2) maintained in accordance with the recommendations given in the instructions for use; and 3) used within the environmental and electrical supply conditions specified in the technical description.