Functions and requirements of medical packaging
Functions of medical packaging:
The country has strict regulations on medical packaging. Today, Xiaobian is here to talk about the requirements and functions of medical packaging. Medical packaging parts are mainly: bags, blister box, Special strong paper. Finally in the way of sterilization, the medical device products into the bag or blister box, sealed, through physical or chemical methods, the bag of microorganisms on the device, and within the specified period of validity, keep the bag or blister box in a sterile state. Specific functions include the following
Can adapt to the corresponding sterilization process;
Protect the device and keep it in an acceptable condition for use;
Bacteria barrier performance, before use can maintain the sterile and integrity of the device;
Can be opened aseptically for use of the device;
Correctly identify and use the product.
General medical packaging can be suitable for sterilization methods: ETO ethylene oxide, high temperature humid steam, Y cobalt-60 ray irradiation, plasma, formaldehyde, etc.
Medical packaging quality technical requirements:
1, Including materials must effectively barrier microorganisms/bacteria ASTM F-1608
2, must adapt to the commitment of sterilization ISO11134ISO11135\ISO11137
3. Maintain the sterile state of the product. Packaging should not be exposed to air pollution, fiber breakage, dust and other foreign substances, microbial invasion (ASTMD-2019). Therefore, packaging should ensure that:
Including material without damage;
General medical packaging can be suitable for sterilization methods: ETO ethylene oxide, high temperature humid steam, Y cobalt-60 ray irradiation, plasma, formaldehyde, etc.
Complete sealing, suitable peel strength (ASTM F88), no penetration (ASTM :1998), no blasting (ASTM F-1150 1 ASTM F-2054), clean peel (EN868-5).
4, including materials or packaging shall be suitable for subsequent processing;
5, after the package is opened, there should be obvious traces to show that it has been opened; After the opening of the package is opened, there should be no arbitrary resealing. (To prevent packaging pollution and then re-close)
6, should mark the opening position and direction, should be easy to open, and the opening position should be convenient for users to open (EN980)
7, must be able to identify the product (the printed shipping mark should meet the requirements of medical devices laws and regulations, including the material has a transparent material, can see the product inside) EN980