Medical grade silicone
Encyclopedia
Medical grade silicones are silicone
s tested for biocompatibility
and are appropriate to be used for medical applications. In the United States, the Food and Drug Administration
(FDA) regulates materials implant
ed into the body. Medical grade silicones are generally grouped into three categories: non implantable, short term implantable, and long-term implantable. Materials approved as USP 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 .
s are widespread in medicine, but have several limitations. For example, they exhibit poor tear strength
and poor resistance to fatigue
. Brittle fracture can occur from defects within sections owing to poor control of vulcanization
. It resulted in high failure rates for breast implants, and much subsequent litigation in the USA, as well as elsewhere in the world. It led to a crisis of confidence in the US, with many manufacturers being forced out of the business entirely, and others to manufacture under FDA control.
Silicone
Silicones are inert, synthetic compounds with a variety of forms and uses. Typically heat-resistant and rubber-like, they are used in sealants, adhesives, lubricants, medical applications , cookware, and insulation....
s tested for biocompatibility
Biocompatibility
Biocompatibility is related to the behavior of biomaterials in various contexts. The term may refer to specific properties of a material without specifying where or how the material is used , or to more empirical clinical success of a whole device in...
and are appropriate to be used for medical applications. In the United States, the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) regulates materials implant
Implant (medicine)
An implant is a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. Medical implants are man-made devices, in contrast to a transplant, which is a transplanted biomedical tissue...
ed into the body. Medical grade silicones are generally grouped into three categories: non implantable, short term implantable, and long-term implantable. Materials approved as USP 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 .
Uses
- Tubing
- Drains
- Feeding tubes
- Catheters
- Implants for long and short term use
- Seals and gaskets
- Scar Treatment Silicone Sheets (FDA Class 1 Medical Device) and gels.
- Condoms
- Menstrual cups http://www.mooncup.co.uk/
- Sex toys
Limitations
Silicone rubber applications such as catheterCatheter
In medicine, a catheter is a tube that can be inserted into a body cavity, duct, or vessel. Catheters thereby allow drainage, administration of fluids or gases, or access by surgical instruments. The process of inserting a catheter is catheterization...
s are widespread in medicine, but have several limitations. For example, they exhibit poor tear strength
Strength
- Physical ability :*Physical strength, as in people or animals*Superhuman strength, as in fictional characters*A common character attribute in role-playing gamesConflict between persons or groups:*Virtue and moral uprightness...
and poor resistance to fatigue
Fatigue
Fatigue may refer to:*Fatigue , structural damage from repeated loading*Fatigue , a state of physical and/or mental weakness*Fatigue , safety implications of tiredness...
. Brittle fracture can occur from defects within sections owing to poor control of vulcanization
Vulcanization
Vulcanization or vulcanisation is a chemical process for converting rubber or related polymers into more durable materials via the addition of sulfur or other equivalent "curatives." These additives modify the polymer by forming crosslinks between individual polymer chains. Vulcanized material is...
. It resulted in high failure rates for breast implants, and much subsequent litigation in the USA, as well as elsewhere in the world. It led to a crisis of confidence in the US, with many manufacturers being forced out of the business entirely, and others to manufacture under FDA control.
See also
- siliconeSiliconeSilicones are inert, synthetic compounds with a variety of forms and uses. Typically heat-resistant and rubber-like, they are used in sealants, adhesives, lubricants, medical applications , cookware, and insulation....
- United States PharmacopeiaUnited States PharmacopeiaThe United States Pharmacopeia is the official pharmacopeia of the United States, published dually with the National Formulary as the USP-NF. The United States Pharmacopeial Convention is the nonprofit organization that owns the trademark and copyright to the USP-NF and publishes it every year...
- U.S. Food and Drug AdministrationFood and Drug AdministrationThe Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
- Silicone rubberSilicone rubberSilicone rubber is an elastomer composed of silicone—itself a polymer—containing silicon together with carbon, hydrogen, and oxygen. Silicone rubbers are widely used in industry, and there are multiple formulations...
- Polymers
- Plastics engineeringPlastics engineeringPlastics engineering encompasses the processing, design, development, and manufacture of plastics products. A plastic is a polymeric material that is in a semi-liquid state, having the property of plasticity and exhibiting flow. The nature of plastic materials poses unique challenges to an engineer...