纸塑医疗器械灭菌包装密封性能的验证标准及测试方法介绍摘要:在灭菌或运输储存过程中,灭菌包装内外会有产生压力差的情况,若装入器械过于紧绷,或灭菌袋剥离强度略有下降,就会导致潜在的泄露和爆开风险。本文通过对GB/T19633-2005和ASTM F 1140两种标准关于密封性的解读,详细论述了纸塑医疗器械灭菌包装的密封性测试方法。关键词:纸塑灭菌包装、破裂/蠕变测试、密封性
Thromboembolic events caused by implanted cardiovascular devices present seriouschallenges to surgeons and researchers alike. In particular bileaflet mechanical heartvalves are prone to thrombus formation in the hinge region due to a combination of highshear stress and stagnation regions. Shear-induced platelet activation and aggregation isusually studied using viscometers, parallel plate flow, and other non-physiologic in vitroconfigurations. However, it is desirable to study this phenomenon in a more physiologicalenvironment.