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What standards should suppliers of medical silicone products meet?

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What standards should suppliers of medical silicone products meet?

The factory standard mainly depends on the product standard. If the product is a class I medical machinery, the requirements for suppliers are not so strict. If it is a class II or class III medical product, it is necessary to carefully select the supplier of medical silicone products.

1、 Hard requirement: ISO13845 medical qualification

To obtain this medical qualification, the production environment and control procedures of the factory must be up to standard. A third party organization will come to review the factory and review the factory every six months. This certificate is the threshold for making medical silicone products.

2、 Material requirements: three or six medical levels

Many customers don't understand what three and six items are, which three items are included, and which six items are included. Now it is popular to everyone. If the customer's products only contact the skin for external use, three items can be used. If the product needs to contact blood, that is according to the six requirements. The three standards include: skin toxicity, skin sensitization, skin irritation, and the six standards include: skin irritation, skin sensitization, hemolysis, in vitro cytotoxicity, and the sixth level of the United States Pharmacopoeia.

The above is the material certification standard, and then the three and six benchmarking items are also divided into many material brands and places of origin. There are domestic and imported, but each brand model is different, but the benchmarking property table is the same. Then silica gel is also divided into solid silica gel and liquid silica gel. The three and six items of solid silica gel and liquid silica gel are also different models and physical property tables. The physical property table of the standard is the same, but the big difference between solid and liquid silica gel is that the molding method is different. But at present, more and more medical silica gel products are produced using liquid silica gel materials

3、 Production environment: dust-free workshop with 100000 level

Many customers say that they have a 100000 level dust-free workshop, but whether they actually meet the standard depends on the fact that a third party organization should conduct random inspection according to the standard of purifying particles in the air, which is based on the square number, and then issue a certificate to the supplier after passing the standard

The 100000 level dust-free workshop is very strict in the control of the workshop. Employees must work in full dust-proof clothing, and fully disinfect before entering the workshop. It is very difficult for customers to visit it.

4、 Production process control

All production procedures of medical silicone products must be operated in a dust-free workshop. The project will issue a production operation instruction, which will be operated with hands throughout the process, and the products produced will be packaged in time. One process of basic medical silicone products is sterilization, but at present many factories do not have this sterilization workshop, so the client will basically install all products before sterilization.

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