Understanding Medical Grade Silicone and Silicone Gaskets

Medical grade silicone is a silicone meant for bio-compatibility and is therefore appropriate to be used is medical applications such as implants. In the U.S., the FDA regulates medical grade silicone and other materials that are meant to be implanted into the human body. Medical grade silicones are usually grouped into 3 distinct categories: short term implantable, long-term implantable and non implantable. Materials approved as USP Class 5 or 6 can generally be considered medical grade. In today’s medical world, most medical grade silicones are at least Class VI certified. Silicone suppliers and some silicone prototyping companies such as Albright Technologies provide guidelines for material use.

To stay on the same topic, did you know what Silicone Gaskets are? Silicone has some of the highest compression set values in the industry, and because of that, it is often used in gasket and o-ring applications. Other benefits of Silicone include: excellent electrical qualities, inert and odorless, extreme temperature applications. Also, Silicone can be steam sterilized, is resistant to many chemicals, highly flexible and durable. Silicone can be compounded for special properties and far exceeds values for thermoplastic elastomers.

Also, Silicone gaskets can be over molded or bonded to other substrates such as thermoplastics, metals and existing silicone parts such as tubing. It is important to understand that overmolding silicone gaskets onto substrate parts is a highly cost-effective technique during production.

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