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CRP  Windform
Stratasys Direct PC-ISO for Parts that can be Sterilized  (Unverified Data**)
Categories: Polymer; 3D Printing/Additive Manufacturing Polymer; Thermoplastic; Polycarbonate (PC)

Material Notes: Polycarbonate-ISO (PC-ISO) is a durable high-performance plastic that meets both ISO 10993-1 and USP Class VI standards in its raw state. PC-ISO can be sterilized using either the gamma radiation or ethylene oxide (EtO) method. PC-ISO parts are built with a layered manufacturing process utilizing Fused Deposition Modeling (FDM) technology, often used in rapid prototyping. This technology can build parts with high-performance engineering materials ideal for functional prototypes and end-use parts.

Applications

Since PC-ISO has the unique feature of being compliant with the ISO-1099-1 and Class VI classification in its raw state, this blend is widely used by packaging and medical device manufactures. PC-ISO can be used in applications such as pharmaceutical material handling, processing, and packaging systems; surgical instruments; food handling and processing systems; automotive lighting; and rapid manufacturing of end-use products.

Note: PC-ISO meets both ISO 10993-1 and USP Class VI standards in its raw state. Parts produced from the FDM process must be re-certified before using in these types of applications. It is the responsibility of the finished device manufacturer to make a determination of the suitability of all the component parts and materials to be used in the finished products.

In a rapid manufacturing application, Polycarbonate-ISO can be used to create actual production parts in lieu of injection molding for short-run production. Rapid (or layered) manufacturing provides multiple benefits:

  • High design iterations – while in production the design engineer has the freedom to modify geometry’s on the fly which cannot be done once you have committed to tooling
  • Bridge manufacturing – with rapid manufactured parts, production can begin while permanent tooling is on order
  • Jigs and Fixtures to be used on manufacturing/production lines
  • For those manufacturers who practice lean manufacturing techniques or who maintain just-in-time inventories, RM can conserve cash flow
  • Alpha and beta product releases – manufacturers can produce accurate, durable products even in the earliest stages of production

Redeye on Demand has been acquired by Stratasys.

Vendors:
Available Properties
  • Specific Gravity, ASTM D792
  • Tensile Strength, Yield, ASTM D638
  • Elongation at Break, ASTM D638
  • Tensile Modulus, ASTM D638
  • Flexural Yield Strength, ASTM D790
  • Flexural Modulus, ASTM D790
  • Izod Impact, Notched, ASTM D256
  • Deflection Temperature at 1.8 MPa (264 psi)
  • Glass Transition Temp, Tg, DMA (SYSS)
  • USP Class VI
  
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Manufacturer Notes:
Stratasys Direct, former RedEye On Demand

Category Notes
Plastic

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USP Class VI Adhesives
USP Class VI Approved Adhesives for Medical Device Applications
Master Bond’s biocompatible adhesives are designed to meet the needs of medical device manufacturers. Compounds withstand various types of sterilization methods.
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