Medical grade silicone
Medical grade silicones are silicones tested for biocompatibility and are appropriate to be used for medical applications. The FDA regulates materials implanted into the body.[1] Medical grade silicones are generally grouped into three categories: non implantable, short term implantable, and long-term implantable. Materials approved as USP [2] Class V and VI can be considered medical grade. Most medical grade silicones are at least Class VI certified. Silicone suppliers and some silicone prototyping companies provide guidelines for material use [3].
History
In 1954, McDougall reported that various tissue cultures taken from warm-blooded animals known to be extraordinarily sensitive to foreign influences showed no deviation from usual growth patterns.
Uses
- Tubing
- Drains
- Feeding tubes
- Catheters
- Implants for long and short term use
- Seals and gaskets
- Condoms
- Menstrual cups [1]
- Sex toys