The manufacturer believesThe packaging design of sterile medical devices must go through a series of systematic steps, not only selecting the correct compliant materials but also choosing suitable packaging forms based on product characteristics. A suitable packaging form can protect the product, facilitate access, or reasonably save costs for manufacturers. Strict sterilization of specific pathogens requires a complete packaging design plan, packaging validation plan, and a series of necessary packaging experimental plans to prove that the packaging system is qualified for sterilization of specific pathogens.Sterile barrier systems are mainly divided into three categories: disposable sterile barrier systems; disposable or reusable packaging materials; reusable sterile barrier systems. Among them, disposable sterile barrier systems achieve sterility barrier functions through sealed packaging.

　　The manufacturer believesThe packaging design of sterile medical devices must go through a series of systematic steps, not only selecting the correct compliant materials but also choosing suitable packaging forms based on product characteristics. A suitable packaging form can protect the product, facilitate access, or reasonably save costs for manufacturers. Strict sterilization of specific pathogens requires a complete packaging design plan, packaging validation plan, and a series of necessary packaging experimental plans to prove that the packaging system is qualified for sterilization of specific pathogens.Due to the pressure difference inside and outside the package during sterilization and transportation of medical devices, if the loaded instruments are too tight or the sealing strength of the sterilization package is insufficient, it will lead to potential risks of leakage and rupture. This fully reflects the importance of sealing strength and sealing integrity at the edges. In practical applications, sealing (peel) strength tests and burst tests are typical sealing strength tests. In sealing strength tests, unless there are very large holes or channels in the sterilization package of medical devices, these holes or channels cannot be detected in sealing strength tests. Sealing strength testing not only needs to assess the pressure on package edges during sterilization and transportation in actual applications but also needs to simulate/evaluate how strong the maintenance of sterility barriers is.

　　The manufacturer believesThe packaging design of sterile medical devices must go through a series of systematic steps, not only selecting the correct compliant materials but also choosing suitable packaging forms based on product characteristics. A suitable packaging form can protect the product, facilitate access, or reasonably save costs for manufacturers. Strict sterilization of specific pathogens requires a complete packaging design plan, packaging validation plan, and a series of necessary packaging experimental plans to prove that the packaging system is qualified for sterilization of specific pathogens.Sterile medical devices refer to those produced by manufacturers that are supplied in a sterile state after sterilization and can be used directly by medical units without further sterilization. This includes disposable sterile medical devices and implantable sterile medical devices. From rural grassroots medical units to large urban tertiary hospitals, sterile instruments are widely used in various processes of disease prevention, diagnosis, and treatment. They are widely applied and frequently come into contact with patients, playing a very important role in China's healthcare security. Therefore, regardless of what causes product safety quality incidents, their wide-ranging impact, significant harm, and long-term social influence cannot be compared with any other medical device.(剥离)强度试验和爆破试验是典型的密封强度试验。在密封强度试验中，除非医疗器械的灭菌包装上有非常大的孔洞或通道，否则在密封强度试验中无法发现这些孔洞或通道。通过密封强度测试不仅需要评估实际应用中灭菌和运输过程中包装边缘受到的压力，还需要模拟/评估维持无菌屏障的强度有多大。

　　The manufacturer believesThe packaging design of sterile medical devices must go through a series of systematic steps, not only selecting the correct compliant materials but also choosing suitable packaging forms based on product characteristics. A suitable packaging form can protect the product, facilitate access, or reasonably save costs for manufacturers. Strict sterilization of specific pathogens requires a complete packaging design plan, packaging validation plan, and a series of necessary packaging experimental plans to prove that the packaging system is qualified for sterilization of specific pathogens.无菌医疗器械是指由生产企业生产，经灭菌后以无菌状态供应，医疗单位可以不经灭菌直接使用的医疗器械。包括一次性无菌医疗器械和植入式无菌医疗器械。从农村基层医疗单位到大城市三甲中心医院，无菌器械被广泛应用于疾病预防、诊断和治疗的各个流程。它们应用广泛，与患者接触较多，在我国医疗卫生保障中发挥着非常重要的作用。因此，无论是什么原因导致的产品安全质量事故，其涉及面之广、危害之大、社会影响之长，是其他任何医疗器械都无法比拟的。

　　The manufacturer believesThe packaging design of sterile medical devices must go through a series of systematic steps, not only selecting the correct compliant materials but also choosing suitable packaging forms based on product characteristics. A suitable packaging form can protect the product, facilitate access, or reasonably save costs for manufacturers. Strict sterilization of specific pathogens requires a complete packaging design plan, packaging validation plan, and a series of necessary packaging experimental plans to prove that the packaging system is qualified for sterilization of specific pathogens.早在20世纪70年代，医疗器械制造商就开始寻求保证无菌产品的安全性和有效性，同时减少医院和供应链中的浪费，为医改提供成本效益。安全已经成为一种基本素质。在这些年的发展中，工作的重点是提高整个无菌屏障医疗器械包装行业的安全性。