(Summary description)

Many people believe that it is the responsibility of medical device manufacturers or packaging manufacturers to certify the indicators of aseptic medical device packaging, and the hospital purchase can be used directly when necessary. In fact, it is not. It is necessary for the hospital to verify in this respect.
Take the sterility retention period as an example, the sterility retention period is the stability verification in iso11607-1, which cannot be carried out according to the accelerated aging method. Natural samples must be used and tested according to the sterility test method. For the method, please refer to the "technical specification for disinfection" issued by the Ministry of health. For the products with the approval of the Ministry of health, the project has been verified in the laboratory designated by the Ministry of health. The hospital can obtain the relevant report from the supplier. The report is effective. The hospital can adopt the product in advance, but the sterility retention period is closely related to the operation and environment of the hospital itself, so the hospital must verify it.
For example, the temperature and time of the sealing machine determine the sealing effect. Sterile medical device packaging manufacturers only provide recommended values, which can not replace their own verification; wrinkled paper, non-woven fabrics, cotton cloth and other materials only have differences in microbial barrier performance, and the packaging made of them will have the problem of sterility retention period after effective sterilization.

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• Time of issue:2020-03-20 15:12
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