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根据《2013年北京市医疗器械质量监督抽验工作计划》,我局组织在全市范围内对医疗器械生产、经营和使用单位进行了抽查检验,现将2013年下半年医疗器械抽验情况及对不合格产品的查处事宜通知如下:一、2013年全年医疗器械抽验情况2013年全年,各区县局、直属分局、市器检所共完成医疗器械抽验任务402批次,不合格17批次,合格率95.77%。二、本期公告概况2013年下半年,全市按照抽验计划共完成医疗器械抽验346批次,不合格14批次,合格率为95.95%(结果详见附件:医疗器械质量公告)。
According to “Beijing 2013 medical equipment quality supervision and sampling inspection work plan”, our bureau organizes the spot check on the medical equipment production, operation and use units in the whole city. Now we will check the medical equipment in the second half of 2013 and the unqualified The investigation and handling of products were notified as follows: I. Examination and Quarantine of Medical Devices in 2013 Throughout 2013, 402 batches of substandard medical device sampling tasks were completed by each of the county bureaus, subordinate bureaus and municipal inspection offices, with 17 batches of unqualified Rate of 95.77%. II. General Information of the Current Issue In the second half of 2013, the city completed a total of 346 batches of medical device tests in accordance with the sampling plan, with 14 failed batches, with a pass rate of 95.95% (for the results, please refer to the Attachment: Medical Device Quality Bulletin).