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(接10月下)2新旧版本规范的主要变化新旧版本规范的主要变化体现在八个方面。2.1更正了文字性错误,规范了用语,删除了目前为III类管理的品名举例,增添了数字化产品的相关举例。例如,将规范名称中“X射线诊断设备”规范为“医用X射线诊断设备”;在X射线成像装置举例中增加了CCD数字摄像系统、CR成像板、DR平板探测器;等等。2.2依据食药监办械[2012]108号文调整了本规范覆盖的产品范围,不再以
(Continued next October) 2 major changes in the old version of the new version of the old version of the specification changes in the main reflected in eight aspects. 2.1 Correct the typographical errors, standardize the wording, delete the name of the current management of Category III, for example, adding examples of digital products. For example, the standard name “X-ray diagnostic equipment ” specification “medical X-ray diagnostic equipment ”; in the X-ray imaging device example an increase of CCD digital camera system, CR imaging plate, DR flat panel detector; Wait. 2.2 Based on Food and Drug Administration regulation [2012] No. 108 to adjust the scope of the product coverage, no longer