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Medical Grade Silicone
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 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 *Catheters *Implant ...
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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 utensils, thermal insulation, and electrical insulation. Some common forms include silicone oil, silicone grease, silicone rubber, silicone resin, and silicone caulk. Chemistry More precisely called polymerized siloxanes or polysiloxanes, silicones consist of an inorganic silicon–oxygen backbone chain (⋯−Si−O−Si−O−Si−O−⋯) with two organic groups attached to each silicon center. Commonly, the organic groups are methyl. The materials can be cyclic or polymeric. By varying the −Si−O− chain lengths, side groups, and crosslinking, silicones can be synthesized with a wide variety of properties and compositions. They can vary in consistency from liquid to gel to rubber to hard plastic. The most common si ...
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Breast Implant
A breast implant is a prosthesis used to change the size, shape, and contour of a person's breast. In reconstructive plastic surgery, breast implants can be placed to restore a natural looking breast following a mastectomy, to correct congenital defects and deformities of the chest wall or, cosmetically, to enlarge the appearance of the breast through breast augmentation surgery. Complications of implants may include breast pain, rashes, skin changes, infection, rupture, cosmetic changes to the breasts such as asymmetry and hardness, and a fluid collection around the breast. The most serious complication is a type of lymphoma (cancer of the immune system) known as Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). There are four general types of breast implants, defined by their filler material: saline solution, silicone gel, structured and composite filler. The saline implant has an elastomer silicone shell filled with sterile saline solution durin ...
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Implants (medicine)
Implant can refer to: Medicine *Implant (medicine), or specifically: ** Brain implant **Breast implant ** Buttock implant **Cochlear implant ** Contraceptive implant **Dental implant ** Fetal tissue implant **Implantable cardioverter-defibrillator ** Orthopedic implant ** Prosthetic implant ** Retinal implant ** Subdermal implant ** Transdermal implant Alternative * Alien implants * Extraocular implant * Implant (body modification) * Implant (thought insertion) *Microchip implant (animal) (human) *'' The Implant'', a television episode of ''Seinfeld'' See also * History of dental treatments * Implantation (other) * Osseointegration *Osseoincorporation Osseoincorporation refers to the healing potential of bone onto an implant surface and into an implant structure. Three-dimensional, porous implantable materials used in the orthopedic and dental implant industries offer the potential for ingrowth ...
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Elastomers
An elastomer is a polymer with viscoelasticity (i.e. both viscosity and elasticity) and with weak intermolecular forces, generally low Young's modulus and high failure strain compared with other materials. The term, a portmanteau of ''elastic polymer'', is often used interchangeably with rubber, although the latter is preferred when referring to vulcanisates. Each of the monomers which link to form the polymer is usually a compound of several elements among carbon, hydrogen, oxygen and silicon. Elastomers are amorphous polymers maintained above their glass transition temperature, so that considerable molecular reconformation is feasible without breaking of covalent bonds. At ambient temperatures, such rubbers are thus relatively compliant ( E ≈ 3 M Pa) and deformable. Their primary uses are for seals, adhesives and molded flexible parts. Application areas for different types of rubber are manifold and cover segments as diverse as tires, soles for shoes, and dam ...
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Biomaterials
A biomaterial is a substance that has been engineered to interact with biological systems for a medical purpose, either a therapeutic (treat, augment, repair, or replace a tissue function of the body) or a diagnostic one. As a science, biomaterials is about fifty years old. The study of biomaterials is called biomaterials science or biomaterials engineering. It has experienced steady and strong growth over its history, with many companies investing large amounts of money into the development of new products. Biomaterials science encompasses elements of medicine, biology, chemistry, tissue engineering and materials science. Note that a biomaterial is different from a biological material, such as bone, that is produced by a biological system. Additionally, care should be exercised in defining a biomaterial as biocompatible, since it is application-specific. A biomaterial that is biocompatible or suitable for one application may not be biocompatible in another. Introduction Bi ...
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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 engineering encompasses plastics material and plastic machinery. Plastic machinery is the general term for all types of machinery and devices used in the plastics processing industry. The nature of plastic materials poses unique challenges to an engineer. Mechanical properties of plastics are often difficult to quantify, and the plastics engineer has to design a product that meets certain specifications while keeping costs to a minimum. Other properties that the plastics engineer has to address include: outdoor weatherability, thermal properties such as upper use temperature, electrical properties, barrier properties, and resistance to chemical attack. In plastics engineering, as in most engineering disciplines, the economics of a product plays an ...
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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 and natural polymers play essential and ubiquitous roles in everyday life. Polymers range from familiar synthetic plastics such as polystyrene to natural biopolymers such as DNA and proteins that are fundamental to biological structure and function. Polymers, both natural and synthetic, are created via polymerization of many small molecules, known as monomers. Their consequently large molecular mass, relative to small molecule compounds, produces unique physical properties including toughness, high elasticity, viscoelasticity, and a tendency to form amorphous and semicrystalline structures rather than crystals. The term "polymer" derives from the Greek word πολύς (''polus'', meaning "many, much") and μέρος (''meros'', ...
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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. Silicone rubbers are often one- or two-part polymers, and may contain fillers to improve properties or reduce cost. Silicone rubber is generally non-reactive, stable, and resistant to extreme environments and temperatures from while still maintaining its useful properties. Due to these properties and its ease of manufacturing and shaping, silicone rubber can be found in a wide variety of products, including voltage line insulators; automotive applications; cooking, baking, and food storage products; apparel such as undergarments, sportswear, and footwear; electronics; medical devices and implants; and in home repair and hardware, in products such as silicone sealants. Curing In its uncured state, silicone rubber is a highly adhes ...
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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 owns the trademark and also owns the copyright on the pharmacopeia itself. The ''USP'' is published in a combined volume with the ''National Formulary'' (a formulary) as the USP-NF. If a drug ingredient or drug product has an applicable ''USP'' quality standard (in the form of a ''USP-NF'' monograph), it must conform in order to use the designation "USP" or "NF". Drugs subject to ''USP'' standards include both human drugs ( prescription, over-the-counter, or otherwise) and animal drugs. ''USP-NF'' standards also have a role in US federal law; a drug or drug ingredient with a name recognized in ''USP-NF'' is considered adulterated if it does not satisfy compendial standards for strength, quality or purity. USP also sets standards for di ...
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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 utensils, thermal insulation, and electrical insulation. Some common forms include silicone oil, silicone grease, silicone rubber, silicone resin, and silicone caulk. Chemistry More precisely called polymerized siloxanes or polysiloxanes, silicones consist of an inorganic silicon–oxygen backbone chain (⋯−Si−O−Si−O−Si−O−⋯) with two organic groups attached to each silicon center. Commonly, the organic groups are methyl. The materials can be cyclic or polymeric. By varying the −Si−O− chain lengths, side groups, and crosslinking, silicones can be synthesized with a wide variety of properties and compositions. They can vary in consistency from liquid to gel to rubber to hard plastic. The most common si ...
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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 the hardening of other (synthetic) rubbers via various means. Examples include silicone rubber via room temperature vulcanizing and chloroprene rubber (neoprene) using metal oxides. Vulcanization can be defined as the curing of elastomers, with the terms 'vulcanization' and 'curing' sometimes used interchangeably in this context. It works by forming cross-links between sections of polymer chain which results in increased rigidity and durability, as well as other changes in the mechanical and electrical properties of the material. Vulcanization, in common with the curing of other thermosetting polymers, is generally irreversible. The word vulcanization is derived from Vulcan, the Roman god of fire and forge. History Rubber—latex ...
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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 development of insights into how biomaterials interact with the human body and eventually how those interactions determine the clinical success of a medical device (such as pacemaker, hip replacement or stent). Modern medical devices and prostheses are often made of more than one material so it might not always be sufficient to talk about the biocompatibility of a specific material. Since the immune response and repair functions in the body are so complicated it is not adequate to describe the biocompatibility of a single material in relation to a single cell type or tissue. Sometimes one hears of biocompatibility testing that is a large battery of in vitro test that is used in accordance with ISO 10993 (or other similar standards) to de ...
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