Sterilization bag-sterilization packaging history.Flexible packaging film roll Packaging

Medical equipment sterilized packaging is an emerging development area. It can be said that it is an emerging industry around the world, and it is also in a constant accumulation summary, and its domestic development is particularly slow. At about 2005, he began to understand the medical device packaging bag, and gradually tied with the sterilization packaging of international medical equipment. In 2007, it was further valued by the country. Introduction to medical equipment sterilization bag packaging medical equipment sterilization packaging should be understood as: packaging for medical device products, which can be sterilized and can be sterilized (such as clean opening). Microbial blocking performance, which can protect the product before and after sterilization, and can maintain the packaging system in the sterile environment inside the system within a certain period of time (the validity period marked) within a certain period of time. Because this concept usually does not include outside protective packaging systems (buffer packaging and collection packaging, etc.), the sterile packaging system of medical equipment can also be called "sterile barrier system". Regarding the form of sterile packaging of medical equipment, there are roughly three categories: 1.1 Soft -sucking molding -filling -heat packaging packaging system: This type of packaging can be divided into two types: flexible and semi -hard type. The bottom material becomes a pre -designed shape through the temperature, vacuum and pressure adjustment of the temperature, vacuum and pressure adjustment on a specific plastic packaging equipment, and combines with the corresponding top material to form a three -dimensional molding packaging system that meets the requirements. The characteristics of this type of packaging are: high degree of automation, high efficiency, low single packaging cost, good coordination of packaging systems and content object shapes, but involving equipment and mold investment, which have certain requirements for output. It is usually used in the output scale. Large, second -class medical device products, such as various syringes, gauze, surgery and medical catheter intubation, etc., as well as simple three types of medical devices, typical venous kernels! 1.2 Hard suction plastic box -cover material packaging system: This type of packaging uses various types of forming sucking boxes to directly seal with a variety of heat -sealing, shapes that are cut in advance. It is more related to the thickness of the sheets used for suctioning and molding. It is usually between 0.4-1.2mm. The materials involved are mainly PVC, PP, PE, PS, PET, PETG And PC, etc., especially PS, PET and PETG, which are commonly used; PVC has gradually been eliminated because of safety and environmental protection issues; PP and PE, which are Physical mechanical performance restrictions are not used in this field; PCs are only applied in a few areas due to high cost reasons. Typical cases such as dry heat sterilization are required. This type of hard plastic box is generally purchased for outsourcing, and then the medical device manufacturers are sealed with the lid materials, and ordinary heating heat sealed equipment can be used. 1.3 Various types of bags packaging systems: including various types of bags: paper plastic bags, top bags, window pockets, blocking bags, paper bags, aluminum foil composite bags with Tyvek The actual situation is designed and produced. In short, it is difficult to summarize its type and scope of application! In China, these products, such as top bags, window bags, and air -breathable bags, have saved the cost of materials due to their special designs for the breathable window, and are welcomed by many medical device companies. The latest 2006 edition of the relevant regulations of the sterilization bag was officially promulgated in April 2006. There are two parts composed of two parts. The first part is mainly about packaging materials, sterile barrier systems and packaging systems. The problem of confirmation of the process of sterilization packaging in medical equipment, so that the sterile packaging is distinguished by the content of the two major subjects according to the design and packaging process of the packaging system. More importantly, in this version, the EN868 standard system that has been combined and merged with the popular European standard system, which eliminates EN868-1, a conflict system that conflicts with each other, and selectively absorb the combination of EN868-2 to -10. The sub-standards of specific materials and products, which actually announced that the global unified medical device sterilization packaging standard was finally born in 2006, both ISO11607-2006. Others such as YY/T0698, which are executed on December 1, 2010, as well as the transformed GB/T19633, ASTM-F88 seal, ASTM-F1929 dyeing penetration, ASTM F1980 accelerated aging, YYT_0681.1-2009_Stac (sterile medical device packaging packaging packaging packaging packaging packaging experiment method

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