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Medical Technology Materials

Tecason™ P XRO:

This is a PPSU product with a radio opacifer. Better visibility provides the surgeon a clearer interpretation of the fit of orthopedic sizing trials particularly in minimally invasive procedures. Radio opacity also provides a safety feature in locating a plastic component during a surgical procedure. This product has been tested by NAMSA and meets USP VI requirements. Tecason™ P XRO has also been tested to ISO 10993 for medical devices intended for less than 24 hours body contact.

Tecapeek™ MT:

Colored rod produced from Victrex’s PEEK 450 resin. Plastics International is currently stocking colored PEEK rod in red 1021, yellow 577, green 579, blue 578 and black 585 colors. All pigments are organic based and are FDA compliant. TECAPEEK™ MT is tested to USP VI on an annual audit basis and is intended for medical instrumentation and orthopedic sizing trials. All colors are stocked domestically in 12 and 25 mm rod. Other rod diameters are available on a custom production basis with a minimum volume of 80 lbs per rod diameter.

Tecapeek™ Classix:

This stock shape is produced from Invibio’s PEEK CLASSIX BC1. The color is an off-white and is designed and supported with biocompatibility testing for applications that require longer exposure to blood and tissue, up to 30 days. Domestic stock of 6, 8, 10, 20, 30 and 45 mm rod is available for immediate shipment. Other rod diameters are available on a custom production basis with a minimum volume of 80 lbs per rod diameter.

Tecamax™ SRP:

The key features of this new polymer chemistry is: high stiffness, 1.2 MPsi flexural moduli without fiber reinforcement, isotropic properties, high tensile strength and radiolucent. The product has been tested by NAMSA and meets USP VI requirements.

San:

This suffix indicates a new line of antimicrobial shapes offered by Plastics International utilizing silver as the active ingredient. The silver system used in our products have proven efficacy against bacteria. TECAFORM™ AH SAN (Acetal) and TECAPRO™ SAN (Polypropylene) are currently available from stock in plate thickness from 0.5" to 4.0". Plastics International is also introducing a filled PTFE product in the SAN family for sanitary seals and gaskets.

Tecaform AH SAN and TECAPRO SAN Safety for Medical Technology

Polyacetal TECAFORM AH SAN and Polypropylene TECAPRO SAN charged with an antimicrobial additive provide additional safety in medical technology. The antimicrobial effect is achieved by a gradual release of silver ions that create the following advantages:

  • Reduced bacterial contamination during downtimes (higher rate of cleanliness)
  • Reduced formation of odor and biofilm on material surface
  • Reduced formation of bacteria in critical points of the equipment
  • Back-up in case of inadequate cleaning (additional safety for customer)
  • Reduced discoloration/corrosion caused by microbes (improved optical characteristics)
  • Homogeneous distribution of active component on material surface
  • No migration of the active component (additional safety for customer)
  • No toxicity of the active component, no toxic decomposition products (harmless to humans)
  • Cleaning or minor abrasion of the surface will continuously renew the antimicrobial effect
  • No thermal damage in the usual application temperature range
  • FDA conformity of raw material, color pigments and the antimicrobial additive
                   
Applications
  • Handles for surgical instruments
  • Surgical trays

Special Applications for TECAPRO SAN
  • Surgical trays (for sterilization and storage)

 

Tecapro MT is  Dimensionally Stable and Light Weight, Resistant to Chemicals with Stable  Color.

Sterilization containers, as an example, for surgical  instruments have to provide high dimensional stability, especially throughout  repeated sterilization cycles. Due to a special stabilization process, TECAPRO  MT shows a better resistance to higher temperatures than standard  polypropylene. Compared to other materials, stainless steel and PTFE for  example, TECAPRO MT possesses a much lower density which results in a reduced  weight of the component parts. The standard color is white, however, other  colors can be produced
according to customer preferences.

TECAPRO MT is available as TECAPRO SAN with an antimicrobial  additive to provide additional safety.

Very stable after  exposure to chemicals.

Properties
  • Good resistance to cleaning agents and
    disinfectants
  • Can be repeatedly sterilized with hot steam
  • High dimensional stability
  • Good machinability
  • Laser marking possible
  • FDA conformity of raw material and color pigments
Preferred Field
  • Medical technology

Applications
  • Surgical trays, surgical related equipment, implant trials

STERILIZATION  TECHNIQUES

Material

Radiation

Autoclave
(Steam)

EtO
(Ethylene Oxide gas)

PEEK

Excellent

Excellent

Excellent

TECASON P (Radel R)

Excellent

Excellent

Excellent

TECAPRO MT

Poor

Excellent

Excellent

NORYL HNA 055

*N/A

Excellent

Excellent

ULTEM 1000

Excellent

Good

Excellent

POLYSULFONE

Excellent

Fair

Excellent

HYDEX 4101 PBT

Good

Poor

Excellent

HYDEX 4301 POLYCARBONATE

Good

Poor

Excellent

ACETAL

Poor

Fair

Excellent

The above table serves as an indication of sterilizable  compatibility. Final applications must be tested on an individual basis.

*There is currently no data available for this technique.

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NOTE: The information contained herein are typical values intended for reference and comparison purposes only. They should NOT be used as a basis for design specifications or quality control. Contact us for manufacturers' complete material property datasheets.
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