Many businesses refer to “medical grade silicone.” One of two things can be inferred from this:

• Long-term implanted medical materials: This medical phrase refers to a substance that can be implanted into the body as a component. It requires permissions and certifications.  It is typically too expensive due to its purity.
• Medical grade: Also known as medical-healthcare grade, class VI silicone evaluated for biocompatibility, this type is our go-to material for a variety of items, such as menstrual cups, infant bottle nipples, and products that come into contact with the skin.

Medical grade silicones are silicones tested for biocompatibility and are appropriate to be used for medical applications.  In India, the Centre for Drugs Standard and Control Organization (CDSCO) regulates the medical devices as per Medical Devices Rules, 2017.  Such medical grade silicones have to be tested for biocompatibility as per ISO 10993 in a NABL accredited laboratory.  

Medical grade silicones are generally grouped into three categories: non implantable, short term implantable, and long-term implantable. Materials approved as Class V and VI can be considered medical grade. Most medical grade silicones are at least Class VI certified. 

Medical-long term implantable and medical-healthcare grade, Class VI, are both regarded as safe for skin contact.