CAJ | 학술논문

医疗器械灭菌包装已广泛应用于医疗行业。医疗器械灭菌包装是为灭菌医疗设备提供无菌屏障,可以实现对微生物的隔离。为了确保包装具有良好的屏障特性,灭菌包装必须能够保证密封性和完好性。验证包装的测试系统包括包装完好性和密封强度测试。灭菌包装的完好性通过物理实验完成。包装的密封强度通过拉伸强度测试和胀破/蠕变压力测试等试验来确定。
의료기계멸균포장이엄범응용우의료행업。의료기계멸균포장시위멸균의료설비제공무균병장,가이실현대미생물적격리。위료학보포장구유량호적병장특성,멸균포장필수능구보증밀봉성화완호성。험증포장적측시계통포괄포장완호성화밀봉강도측시。멸균포장적완호성통과물리실험완성。포장적밀봉강도통과랍신강도측시화창파/연변압력측시등시험래학정。
Terminally sterilized medical packaging has been used widely in the medical industry,which must provide a microbial barrier between the medical device and the external environment,and this barrier must be maintained against microbial challenges.In order to make good barrier performance,the package must have the ability to maintain sterile package salability and integrity.A validatable package testing system must include package integrity testing and seal strength testing.Tensile strength testing and inflation testing are used to determine seal strength,and validated physical test methods are acceptable for determining the package integrity.