Technical requirements for quality of sterilizing and sterilizing bags

1. The included materials must be effectively resistant to microorganisms/bacteria ASTM F-1608

2. Must adapt to the promised sterilization method ISO11134ISO11135ISO11137

3. Maintain the aseptic state of the product. Packaging must not be exposed to air pollution, fiber damage, dust and other foreign matter, microbial invasion (ASTM D-2019).

Therefore, packaging should ensure that:

-- including the material without breakage;

-- Complete sealing, suitable peel strength (ASTM F88), no penetration (ASTM F199:1998), no blasting (ASTM F-1150 / ASTM F-2054), peel clean (EN868-5).

4. including the material or packaging should be subsequent to be processed;

Materials must be manufactured to minimize particle loss, such as fiber, sheet, ink loss, dust. (ASTM D - 2019)

5. After the packaging is opened, there should be obvious traces showing that it has been opened;

There should be no arbitrary re-sealing after the opening of the packing opening. (to prevent the packaging from being contaminated when opened and then closed again)

6. The opening position and direction should be marked;

It shall be easy to open and in a position convenient for the user to open (EN980)

7. must be able to identify the product (printing marks should comply with the requirements of medical equipment laws and regulations, including the material has a transparent material, you can see the internal products) EN980