橡胶外科手套测试分析及监督抽检方案的研究
Research on Detailed Test Analysis and Sampling Test Scheme of Surgical Gloves
胡晓亮 1曲翠翠 1王龙浩 1甄辉 1张莉 1徐方明1
作者信息
- 1. 浙江省医疗器械检验研究院,浙江杭州 310018
- 折叠
摘要
医用橡胶手套多家实验室比对结果不满意,依据日常检测经验,对检测过程中未规定的工装材料、夹具以及测试步骤提出解决方案,供其他实验室参考.为验证外科手套拉伸性能测试结果与试样裁样方向有关,对外科手套按长度、宽度方向裁样,进行拉伸性能测试.研究表明,老化前、老化后外科手套的拉伸性能,长度方向裁样测试数据优于宽度方向裁样测试数据.根据验证结果,对检测机构和外科手套标准起草单位提出优化意见.为加强外科手套的监管,制定监督抽检的抽检方案,供监管部门参考.
Abstract
A number of laboratories were not satisfied with the results of the comparison test of medical rubber gloves.According to the daily testing experience,solutions were proposed for the unspecified tooling materials,fixtures and test steps in the testing process for reference by other laboratories.In order to verify that the test results of surgical gloves are related to the cutting direction of dumbbell sample,the surgical gloves are cut separately according to the length and width direction,and the tensile properties are tested.The results show that the force at break and elongation at break of surgical gloves before and after aging are better in length direction than in width direction.According to the verification results,opinions were put forward for testing institutions and standard drafting units of single-use sterile rubber surgical gloves.In order to strengthen the supervision of surgical gloves,a sampling inspection plan for supervision was developed for reference of the supervision department.
关键词
医用橡胶手套/外科手套/拉伸性能/监督抽检Key words
medical rubber gloves/surgical gloves/tensile property/supervision and inspection引用本文复制引用
基金项目
浙江省药品监管系统科技计划项目(2022028)
出版年
2024
国家科技期刊平台
NSTL
万方数据