1, including the material must be effective barrier to microorganisms/bacteria ASTM F-1608
2, must adapt to the promised sterilization ISO11134\ISO11135\ISO11137
3, to maintain the product's sterility. Packaging can not have the opportunity to be contaminated by air, fiber breakage, dust and other foreign matter, microbial invasion (ASTM D- 2019) . Therefore, the packaging needs to ensure:
--Including materials without breakage;
--Sealing integrity, peel strength (ASTM F88) appropriate, no penetration (ASTM :1998), no bursting (ASTM F-1150 / ASTM F-2054), peeling clean (EN868-5).
4, including the material or packaging should be suitable for subsequent processing;
Materials must be manufactured to minimize the shedding of particles, such as fibers, flakes, ink shedding, dust. (ASTM D-2019
5. After the package is opened, there should be obvious traces that it has been opened;
After the package is opened, there should be no arbitrary re-sealing. (Prevent the package from being opened by the contamination and then reclosed)
6, should mark the opening position and direction;
Should be easy to open, and the opening position should be convenient for the user to play open (EN980)
7, must be able to identify the product (printed mark should be in line with the requirements of the medical device laws and regulations, including the material has a side of the material transparent material, you can see the product inside) EN980
Medical device sterilization packaging-chemical indicators and printing ink
1, sterilization color change chemical indicators, the product is similar to printing ink, the processing principle of the same printing ink, usually printed on the inside or outside of the bag. The principle is that under specific sterilization conditions, the indicator printing ink from the initial color into a pre-set color. Function is to visually indicate whether the sterilized product after and in accordance with the specified sterilization conditions. Sterilization color change chemical indicator is divided into water-based and oil-based, the difference is that water-based does not contain heavy metals.
2, printing ink, usually divided into water-based and oil-based, based on the quality requirements of medical products, medical packaging is usually used in water-based ring-packed ink, the ink should be through the ISO10993 biocompatibility test, the content of heavy metals in line with the requirements of the IEC 62321:2008, the US EPA 3052:1996 requirements