国家医疗器械监督抽检中手术衣产品情况分析

Analysis of surgical gown products during national medical device supervision and inspection

详细介绍了2015—2021年手术衣产品国家医疗器械监督抽检情况及国内外手术衣相关标准,阐述了2015—2021年国家医疗器械监督抽检中手术衣产品不合格率的变化趋势及行业标准执行情况,指出了手术衣产品存在使用不合格原材料、不同抽样环节产品质量不一、标示生产单位确认非其厂家生产等问题并提出了针对性建议,为手术衣产品整体质量的提高提供了参考。

The status of surgical gown products during national medical device supervision and inspection from 2015 to 2021 was introduced in detail,and corresponding standards for surgical gown products in foreign countries and China were expounded.The changing trend of the failure rate of surgical gown products during national medical device supervision and inspection from 2015 to 2021 and the implementation of industry standards were elaborated.It's pointed out surgical gown products had problems in unqualified raw materials,varied product quality during different inspection links and inconsistency of marked and actual manufactures.Some countermeasures were put forward accordingly,and references were provided for enhancing the quality of surgical gown products.