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What kind of silicone products can reach medical grade?

2023-07-07
Latest company news about What kind of silicone products can reach medical grade?

Silica gel is a kind of polymer material widely used in medical, food, industry and other fields. To achieve medical grade, silicone products need to meet the requirements of the following aspects.

 

First of all, silicone products are required to use a sterile environment in the production process. Medical silicone products need to ensure that their use will not cause damage to the body, so the production process needs to exclude bacteria and other sources of pollution to prevent possible cross infection.

 

Secondly, silicone products need to pass strict quality testing. Medical silicone products need to have high purity, high elasticity, high transparency and other characteristics, need to pass various kinds of testing and certification, such as ISO9001 quality management system certification, FDA certification, European CE certification, etc., to ensure that it meets medical standards.

 

Finally, silicone products need to meet strict biocompatibility requirements. Medical silicone products need to be in contact with human tissues, physiological fluids, etc., so it is necessary to assess the impact of biological buffering, immunity, damage, etc., to ensure that silicone products will not have a negative impact on the human body.

 

Medical silicone products need to meet certain standards in manufacturing, quality testing and biocompatibility to ensure their safe and effective application in the medical field and escort people's health.