避孕套包装完整性试验的方法探究  

Research on the Methods of Condom Packaging Tightness

作　　者：晏子樱 林冬昕 陈少敏 YAN Zi-ying;LIN Dong-xin;CHEN Shao-min(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangdong Guangzhou 510663)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663

出　　处：《中国医疗器械信息》2022年第15期18-20,24,共4页China Medical Device Information

摘　　要：目的:对避孕套包装完整性试验进行方法探究。方法:避孕套传统包装为一层或多层柔性复合膜热封制成的正方形或长方形包装,一种新式的碗状包装并不完全适用该方法。通过调整真空度进行试验探究,以及人为制造阳性样品的方式进行方法验证,改进此类包装的包装性试验方法。结果:对于非柔性复合膜制成的避孕套包装,降低真空度进行包装完整性测试可以避免出现完整包装破裂的假阳性结果,也可以使用人为扎针孔制成的阳性样品验证该测试压力值是否过低,避免出现漏检的假阴性结果。结论:通过调整真空度测试以及用阳性样品验证的方式进行非柔性复合膜制成的避孕套包装的包装完整性检测,可以提高检测的准确度和可靠性。Objective:Research the condom packaging tightness.Methods:Traditionally,the Packaging of condoms is square or rectangular package made of one or more layers of flexible composite film.A new type of bowl-shaped packaging is not entirely suitable for this method.By adjusting the vacuum and using the positive samples,improve the methods of condom packaging integrity.Results:For the condom package which made of non-flexible composite film,by reducing the vacuum degree for condom packaging tightness and verification with positive sample can avoid the false positive result of complete package rupture,and verification whether the vacuum degree is suitable,thus avoid the false negative result of missed inspection.Conclusion:The experiment by adjusting the vacuum degree and verification with positive sample,can improve accuracy and reliability of the condom packaging tightness which made of non-flexible composite film.

关 键 词：医疗器械 天然橡胶胶乳避孕套 包装完整性 检测与监管 

分 类 号：TH789[机械工程—仪器科学与技术]