Medical grade silicones are
silicone
A silicone or polysiloxane is a polymer made up of siloxane (−R2Si−O−SiR2−, where R = organic group). They are typically colorless oils or rubber-like substances. Silicones are used in sealants, adhesives, lubricants, medicine, cooking ...
s tested for
biocompatibility
Biocompatibility is related to the behavior of biomaterials in various contexts. The term refers to the ability of a material to perform with an appropriate host response in a specific situation. The ambiguity of the term reflects the ongoing de ...
and are appropriate to be used for medical applications. In the United States, the
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(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 regulate 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 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. Silicone suppliers and some silicone prototyping companies provide guidelines for material use.
Uses
*Tubing
*
Drains
*Feeding tubes
*
Catheter
In medicine, a catheter (/ˈkæθətər/) is a thin tube made from medical grade materials serving a broad range of functions. Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. Cath ...
s
*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 cup
A menstrual cup is a menstrual hygiene device which is inserted into the vagina during menstruation. Its purpose is to collect menstrual fluid (blood from the uterine lining mixed with other fluids). Menstrual cups are usually made of flexible ...
s
*Sex toys
*Non-Stick Containers
*Respiratory masks
Limitations
Silicone rubber applications such as
catheter
In medicine, a catheter (/ˈkæθətər/) is a thin tube made from medical grade materials serving a broad range of functions. Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. Cath ...
s are widespread in medicine, but have several limitations. For example, they exhibit poor tear
strength
Strength may refer to:
Physical strength
*Physical strength, as in people or animals
* Hysterical strength, extreme strength occurring when people are in life-and-death situations
*Superhuman strength, great physical strength far above human c ...
and poor resistance to
fatigue
Fatigue describes a state of tiredness that does not resolve with rest or sleep. In general usage, fatigue is synonymous with extreme tiredness or exhaustion that normally follows prolonged physical or mental activity. When it does not resolve ...
. Brittle fracture can occur from defects within sections owing to poor control of
vulcanization
Vulcanization (British: Vulcanisation) is a range of processes for hardening rubbers. The term originally referred exclusively to the treatment of natural rubber with sulfur, which remains the most common practice. It has also grown to include ...
.
[{{Citation, last1=Swanson, first1=J. W., title=The Effect of Implantation on the Physical Properties of Silicone Rubber, date=1975, work=Biomedical Applications of Polymers, pages=197–211, publisher=Springer US, isbn=978-1-4899-5021-5, last2=LeBeau, first2=J. E., doi=10.1007/978-1-4899-5019-2_18] 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
*
Silicone
A silicone or polysiloxane is a polymer made up of siloxane (−R2Si−O−SiR2−, where R = organic group). They are typically colorless oils or rubber-like substances. Silicones are used in sealants, adhesives, lubricants, medicine, cooking ...
*
United States Pharmacopeia
The ''United States Pharmacopeia'' (''USP'') is a pharmacopeia (compendium of drug information) for the United States published annually by the United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that ...
* U.S.
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
*
Silicone rubber Silicone rubber is an elastomer (rubber-like material) 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
A polymer (; Greek '' poly-'', "many" + ''-mer'', "part")
is a substance or material consisting of very large molecules called macromolecules, composed of many repeating subunits. Due to their broad spectrum of properties, both synthetic an ...
*
Plastics engineering
Plastics 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. Plastics engineer ...
References
Biomaterials
Elastomers
Implants (medicine)
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