近日,吉林省食品药品监管局申报的定制式活动义齿、电脑中药熏蒸(洗)多功能治疗机、紫外线治疗仪三个产品的地方标准制订项目列入2016年度吉林省地方标准立项计划,这是吉林省首次制定医疗器械地方标准。
定制式活动义齿主要用于人体损坏牙齿的修复,电脑中药熏蒸(洗)多功能治疗机用于对人体有病变部位进行辅助的治疗。目前,两类产品均无具体的国家标准和行业标准,各生产企业自行制定的产品技术要求不一致,存在一定风险和隐患。地方标准制定后,对提高产品质量,保证公众使用安全有一定的积极作用。
紫外线治疗仪通过紫外线照射解决人体对紫外线剂量吸收不足问题,虽然已有行业标准,但未针对具体治疗项目划分,此次吉林省局制定了高于行业标准的地方标准,有利于产品的规范化监管和质量提升。
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