Sterile medical devices
1. Disposable sterile medical devices: refers to medical devices that are sterile, pyrogen-free, pass inspection, and used directly within the validity period. It can also be understood as: a sterile medical device that is only for one-time use and destroyed after use.
2. Classification of disposable sterile medical devices: according to different uses of products, they can be divided into:
① Disposable infusion, blood transfusion and injection equipment.
② Disposable sanitary dressing
③ All kinds of medical catheters and others
3. Disposable sterile medical device packaging: it can be used for packaging medical device products, which can be sterilized, sterile operation (such as clean opening), and can provide acceptable microbial barrier performance. Before and after sterilization, it can protect the product and maintain the sterile environment within a certain period (marked validity period) after sterilization. It can also be understood that: medical devices produced and sterilized by the production enterprise are supplied in sterile state, and medical units do not need to sterilize again and directly use medical devices.
4. Initial packaging: the packaging material directly in contact with medical devices, namely, single or internal packaging of medical devices. According to the contact form, there are two types: one is direct contact with the surface of use; The other is in direct contact with the product, but not with the surface used.
5. The main function of medical device packaging is to provide protection in the process of supply and sterilization, and finally ensure that the device is in sterile state before use.
Introduction of packaging types of disposable sterile medical devices
Classification:
According to the structure, it can be divided into: flat bag; tube bag; self-sealing bag; breathable window bag; middle-sealed bag; head bag; three-dimensional bag; blister (blister); wrapping materials, etc.
According to the sterilization method, it can be divided into: ETO ethylene oxide, high temperature and humid steam, gamma cobalt 60 ray irradiation, plasma, formaldehyde, etc.
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