What Is Medical Grade Silicone

1. Medical grade silicone

Silicone is a versatile material that can be used for a ton of stuff, including things like medical implants. ‘Medical-Grade’ means the silicone has been tested and approved by the FDA for biocompatibility – so it’s designed to be worn safely inside the body for long periods of time. Medical grade silicone is hypoallergenic, latex-free and contains no toxins, and is also nonporous and so resists bacterial growth.

Medical-grade silicones are silicones tested for biocompatibility and are appropriate to be used for medical applications. In the United States, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) regulates devices implanted into the body. It does not regulate materials other than certain dental materials. The FDA regulates silicones used in food contact under the auspices of the Center for Food Safety and Nutrition (CFSAN) and for use in pharmaceuticals under the auspices of the Center for Drug Evaluation and Research (CDER).

Medical grade silicone is a class of clinically-tested products designed to interact safely with the human body in a medical setting. The many uses and forms of medical silicone make it difficult to define and classify. But before it can be applied medically, it must pass rigorous FDA standards. Because medical silicone is safe and durable, it can be engineered for short-term or long-term use. Such items like tubes, dental retainers, implants, respiratory masks, and gel sheets for scar therapy all contain medical-grade silicone.

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 Grade Silicone is designed for health care applications that require a low volatile, non-toxic, FDA material with extremely high and low-temperature resistance.  This material was formulated with a silicone base that has been tested and complies with UPS Class VI.  Medical Grade Silicone Sheeting is platinum cured and is an excellent gasket material because it has exceptional resistance to ozone, oxidation, ultraviolet light and extreme temperatures.

2. Why is Silicone good for Medical Applications

  • Silicone is a biocompatible material
  • Silicone is easy to sterilize
  • Silicone is an effective barrier against bio-materials within bio-medical devices and implantables
  • Silicone is resistant to temperature, UV radiation, and X-rays
  • Silicone doesn’t adhere to body tissue
  • Silicone does not support microbial growth
  • Silicone provides electrothermal insulation
  • Silicone can be used as a no-slip surface
  • Silicone is soft and pliable and does not crack
  • Medical grade silicone is safe/sterile alternative to latex
  • Medical grade silicone FDA biocompatibility
  • Medical grade silicone resistance to chemical and bacteria
  • Medical grade silicone excellent transparency, which allows light Medical grade silicone transmittance and illumination
  • Medical grade silicone Gas permeability
  • Medical grade silicone Clarity
  • Medical grade silicone High elongation
  • Medical grade silicone Superior dielectric strength
  • Medical grade silicone Superior tensile strength, elongation, tear Medical grade silicone strength and compression at temperature extremes
  • Medical grade silicone Ability to function in extreme temperatures
  • Medical grade silicone Low compression set at wide temperature ranges

3. The use of Medical Grade Silicone Rubber

  • Tubing
  • Drains
  • Feeding tubes
  • Catheters
  • Implants for long and short term use
  • Seals and gaskets
  • Syringe pistons
  • Scar Treatment Silicone Sheets (FDA Class 1 Medical Device) and gels.
  • Condoms
  • Menstrual cups
  • Sex toys
  • Non-Stick Containers
  • Respiratory masks

4. Conclusion

To learn more about medical-grade Liquid Silicone Rubber or receive a free quote, contact Z.S.R Group representative today.