Medical Industry Applications

904 West 6th Street, Shiner, Texas 77984 USA
Phone: 1-361-594-2941     Fax: 1-361-594-2349     E-Mail: bpi@boedeker.com

1-800-444-3485

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Food & Drug Regulatory Overview

Every day, plastics are involved in critical surgeries, life-saving efforts, and routine medical procedures. Plastic materials can be sterilized hundreds of times without degradation. Lightweight plastics are used to form replacement joints, non-surgical supports, and therapy equipment. Clear plastics provide visibility for transfusions, surgeries, and diagnostic equipment of all kinds. And plastics can be machined, molded, or formed into almost any shape imaginable.

The paragraphs below describe specific materials and their uses in this industry . . .

See our table showing Agency Approvals and Listings for many plastic materials.

( see also ESD Materials -- AntiStatic, Static Dissipative & Conductive Plastics )

• PEEK (polyetheretherketone)            
  PEEK offers exceptional chemical resistance combined with heat resistance to 480°F. It does not degrade with exposure to water or steam, and is flame- and radiation-resistant. Because of these properties, PEEK can withstand the chemical and mechanical stresses present during sterilization and chemical cleaning. This material is available in sheet, rod and tube forms.
  
  
• KETRON^® PEEK-LSG            
  Ketron ^® PEEK-LSG natural / black stock shapes are produced from selected batches of Victrex ^® PEEK PolyEtherEtherKetone resin. This material exhibits a unique combination of mechanical properties, temperature and chemical resistance. This material is FDA and USP approved and may be implanted for up to 24 hours. This material is available in sheet and rod forms in natural and black colors.
  
  
• KETRON^® PEEK-CA30 LSG            
  KETRON ^® PEEK-CA30 LSG PolyEtherEtherKetone stock shapes are produced from genuine Victrex ^® PEEK polymer. This 30% carbon fiber-reinforced grade combines even higher stiffness, mechanical strength and creep resistance than KETRON ^® PEEK-GF30 LSG blue with an optimum wear resistance. This material is USP approved and may be implanted for up to 24 hours. This material is available in sheet and rod forms and is black in color.
  
  
• KETRON^® PEEK-GF30 LSG            
  KETRON ^® PEEK-GF30 LSG PolyEtherEtherKetone blue stock shapes are produced from genuine Victrex ^® PEEK polymer. This 30% glass fiber-reinforced grade offers higher stiffness and creep resistance than KETRON ^® PEEK-LSG and has much better dimensional stability. This material is USP approved and may be implanted for up to 24 hours. This material is available in sheet and rod forms and is blue in color.
  
  
• KETRON^® PEEK-CLASSIX LSG            
  KETRON ^® PEEK-CLASSIX ^® LSG PolyEtherEtherKetone white stock shapes are produced from Invibio ^® PEEK-CLASSIX ^® White resin. This material exhibits a unique combination of mechanical properties, temperature and chemical resistance. This material is FDA and USP approved and may be implanted for up to 30 days. This material is available in sheet and rod forms and is white in color.
  
  
• TECHTRON^® HPV LSG            
  TECHTRON ^® HPV LSG PolyPhenylene Sulfide PPS from a proprietary reinforced and internally lubricated PPS-based compound. This material exhibits a unique combination of properties including wear resistance, load bearing capability and dimensional stability when exposed to chemicals and high temperature environments. This material is FDA and USP approved and may be implanted for up to 24 hours. Techtron HPV LSG is available in sheet and rod forms and is blue in color.
  
  
• Tecason ^™ P XRO            
  TECASON ^™ P XRO PolyPhenylSulfone is a new line of x-ray opaque thermoplastic shapes. A radio opacifer is added to the standard line of colored PPSU extruded rod for orthopedic sizing trials and other instrument devices allowing for clear visibility of the component on fluoroscopy and X-ray. This material is available only in rod form.
  
  
• Tecanyl ^™ MT (PPE+PS-HI)            
  TECANYL ^™ MT is a new shapes offering from Ensinger Industries and is produced from GE Plastics’ NORYL ^® PPE+PS (Polyphenylene Ether + PS-HI) HNA055 resin. In-house specimen testing performed at GE has demonstrated that NORYL ^™ HNA055 resin is an excellent material candidate for medical device applications destined for the repeated exposures of autoclaving cycles. It has good impact properties and is easily machined. This material is available only in rod form.
  
  
• TecaMax ^® Self-Reinforcing Polymer            
  TecaMax SRP has the highest strength-to-weight ratio and stiffness of any thermoplastic available in the world today. Combined with its remarkable chemical resistance and dimensional stability, TecaMax SRP is ideal for medical devices and surgical instrumentation. Developed only recently, this material is available in molded sheet and rod.
  
  
• Topas ^® COC (Cyclic Olefin Copolymer)            
  Topas COCs have a very high moisture barrier, low water absorption, good resistance to hydrolysis and chemical media, and low density. In addition, they typically offer high transparency extending into the UV range, low birefringence, adjustable heat deflection temperature and high rigidity. Examples of applications for Topas COC plastics include films for pharmaceutical and personal health care blister packs, food packaging, medical syringes and vials, diagnostic articles, optical lenses, light guides, and optical sensors. This new material is available in molded sheet and rod.
  
  
• Ultem ^® Polyetherimide            
  Because of its superior physical properties and its ability to withstand a wide spectrum of sterilization methods, Ultem is often specified as the material of choice in demanding reusable medical device applications. In Ultem's natural unpigmented form, it meets the requirements of USP Class VI and is FDA compliant. Custom FDA compliant colors further expand its appeal in a variety of applications such as color coded orthopaedic provisional trials.
  
  
• Acetal Copolymer            
  Acetal Copolymer is a well-recognized engineering thermoplastic which is widely used in many medical applications. Acetals may be steam autoclaved, are easily machined, and are available in seven lot-controlled FDA-compliant colors. Acetals are an excellent choice for color coded provisional trials. Acetals are also USP Class VI compliant.
  
  
• Propylux ^® HS (Heat Stabilized Polypropylene)            
  Propylux^® HS Heat Stabilized Polypropylene sheet provides all of the outstanding properties found in standard polypropylene, but has been subjected to a special heat-stabilizing process. As a result, Propylux^® HS is able to withstand higher service temperatures with less water absorption than standard polypropylene. Recommended sterilization techniques include steam autoclaving and cold sterilization. This lot-controlled material is available in WHITE SHEET ONLY.
  
  
• TecaPro ^® MT (Heat Stabilized Polypropylene)            
  TecaPro^® MT Heat Stabilized Polypropylene sheet provides all of the outstanding properties found in standard polypropylene, but has been subjected to a special heat-stabilizing process. As a result, TecaPro^® MT is able to withstand higher service temperatures with less water absorption than standard polypropylene. Recommended sterilization techniques include steam autoclaving and cold sterilization. This lot-controlled material is available in WHITE SHEET ONLY.
  
  
• Radel^® A PolyEtherSulfone            
  Radel^® A PolyEtherSulfone is also sometimes called PolyArylSulfone. With outstanding chemical resistance for an amorphous thermoplastic, Radel^® A withstands cold sterilants, disinfectants, and germicides. A UL 94 V-0 rated material at .020" thickness, this is the material of choice for electro-mechanical surgical tools. Dimensional stability and maintenance of physical properties at elevated temperatures are among its key features. USP Class VI, FDA compliance and compatibility with all sterilization techniques complete the list of features of this high performance product.
  
  
• Radel^® R PolyArylEtherSulfone            
  Radel^® R PolyArylEtherSulfone (PAES) is also commonly referred to as Polyphenylsulfone (PPSU). Radel^® R has virtually unlimited steam sterilizability, making it an excellent choice for medical devices. It also resists common acids and bases -- including commercial washing solutions -- over a broad temperature range. Radel^® R is available in transparent, natural (bone white), and custom colors. It is commonly used in sterilization trays, dental and surgical instrument handles, orthopedic implant trials and in fluid handling coupling and fitting applications.
  
  
• Udel ^® Polysulfone            
  One of the first high temperature thermoplastic materials to be sterilizable by all techniques, polysulfone meets the demanding requirements of FDA and USP. The availability of a clear grade makes this material the only choice for sterilizable vacuum-formed medical equipment. Grades may be specified for ASTM F702-81 certification, other FDA specifications, and custom colors to complement this material's broad offering to the medical industry.
  
  
• Noryl ^® PPO (Polyphenylene Oxide & Styrene)            
  Noryl is an important structural material with high strength and excellent temperature resistance. It may be machined to close tolerances and maintains dimensional stability even when exposed to moisture. It may be used continuously at temperatures in excess of 220°F.
  
  
• Polycarbonate            
  Some medical instruments or containers require glass-like transparency, FDA compliance and excellent impact resistance. With these material parameters, polycarbonate is sometimes the only suitable material, especially, where components must be machined to close tolerances.
  
  
• ABS            
  ABS is a general purpose amorphous thermoplastic, providing good impact strength, toughness, stiffness, and good chemical resistance. FDA compliant grades are available. ABS is easily machined and is cost effective.
  
  
• UHMW-PE (Ultra High Molecular Weight Polyethylene)            
  The diverse uses of lot-controlled UHMW-PE range from standard wear applications to implantable products. Biocompatibility, self-lubrication, and wear resistance are among the major requirements of articulating surfaces made from UHMW-PE. The biological response to UHMW in soft tissue and bone has been well characterized by a history of clinical use. Traceability from resin through finished product is available to meet ASTM F648-84 guidelines.
  
  
• Polystyrene            
  Known primarily for its clarity and good electrical properties, polystyrene is frequently used in dosimetry applications where water is the recommended medium of choice. The electron composition of polystyrene is almost the same as water, and several of its physical parameters needed for dose measurement are well established. Using a polystyrene phantom, one can determine the dosage necessary to irradiate a tumor in a patient.
  
  

BPI Home Page | Other Applications | Materials Guide | Contact Us!

Boedeker Plastics, Inc.
904 West 6th Street, Shiner, Texas 77984 USA
USA TOLLFREE : 1-800-444-3485
Phone: 1-361-594-2941     Fax: 1-361-594-2349     E-Mail: bpi@boedeker.com

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