16种医用口罩口罩带的细胞毒性  

Cytotoxicity of the Mask Belts of 16 Kinds of Medical Masks

作　　者：曾亚力 王蕊 管博 李华 戴政宁 贺学英 Zeng Yali;Wang Rui;Guan Bo;Li Hua;Dai Zhengning;He Xueying(Beijing Institute of Medical Device Testing,Beijing 101111,China)

机构地区：[1]北京市医疗器械检验所,北京101111

出　　处：《医疗装备》2022年第1期45-47,50,共4页Medical Equipment

摘　　要：目的通过在现行安全使用的前提下对国内14个厂家的16种医用口罩口罩带的细胞毒性进行研究,以期为相关标准修订时对口罩带细胞毒性做出合理要求提供数据支持。方法将16种医用口罩依次编号为1^(#)~16^(#),根据GB/T 16886.5-2017《医疗器械生物学评价第5部分:体外细胞毒性试验》,对16种医用口罩的口罩带进行细胞毒性试验。结果1^(#)~3^(#)被检样品的口罩带含有橡胶材质,细胞毒性大,细胞相对增殖率(RGR)均小于3.0%;4^(#)~15^(#)被检样品的口罩带材质为氨纶加涤纶或氨纶加锦纶,细胞RGR介于3.7%~56.9%;16^(#)被检样品的口罩带材质为非织造布,细胞RGR为88.2%。结论不同材质口罩带的细胞毒性差异很大,医用口罩相关标准宜根据材质类型及实际使用风险合理规定口罩带的细胞毒性。Objective Through investigating on the cytotoxicity of the mask belts of 16 kinds of medical masks from 14 manufacturers in China,we provided data support for making reasonable requirements for the cytotoxicity of mask belts in the revision of relevant standards under the premise of current safe use.Methods According to GB/T 16886.5-2017 Biological evaluation of medical device-Part 5:Tests for in vitro cytotoxicity,the cytotoxicity tests of mask belts of 16 kinds of medical masks were carried out.Results The mask belts of samples 1^(#)~3^(#) were made of rubber material,which showed high cytotoxicity and the RGR was less than 3%;the mask belts of samples 4^(#)~15^(#) were made of spandex and polyester or spandex and nylon,and the RGR ranged from 3.7%to 56.9%;the mask belt of sample 16^(#) was made of non?woven fabric,and the RGR was 88.2%.Conclusions The cytotoxicity of mask belts of different materials varies greatly.The relevant standards for medical masks should reasonably regulate the cytotoxicity of mask belts based on the type of material and the actual risks of use.

关 键 词：医用口罩 口罩带 标准 细胞毒性 非织造布 

分 类 号：R197.39[医药卫生—卫生事业管理]