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Ketron® LSG PEEK

Poly-ether-ether-ketone
Technical datasheet

Ketron® LSG PEEK (Life Science Grade) stock shapes are made from unfilled PEEK resin. Both resin and stock shape are pre-assessed for biocompatibility for up to 24 hours contact with body and tissue according to USP VI and ISO 10993. Some color variations are also pre-assessed for wetted contact applications in bioprocessing.

Ketron® LSG PEEK shapes exhibit high stiffness and mechanical strength. The components are also sterilizable by means of steam (autoclave), dry heat, EtO (Ethylene Oxide), plasma, and gamma- & X-ray irradiation, making this material an excellent candidate for applications in the medical and bioprocessing fields, such as endoscopes/laparoscopes, manifolds, valves, connectors, lids, and adapters.

Ketron® LSG PEEK plastic stock shapes in grey
Product Information

Material Properties

  • Pre-assessed on both resin and stock shapes for up to 24 hours contact with body or tissue according to USP VI and ISO 10993
  • Some color variations pre-assessed for wetted contact in bioprocessing
  • Unfilled PEEK base for high mechanical strength and chemical resistance
  • Excellent sterilization resistance via steam, dry heat, EtO, plasma, and gamma- & X-ray irradiation
  • Exceptional resistance to high temperatures

Available Geometries

Ketron® LSG PEEK stock shapes encompass a range of standard sizes in the following geometries: Rod, Plate

Rod
Plate

Available Colors

Ketron® LSG PEEK stock shapes come in the following colors: Natural (beige), Black, Red, Yellow, Blue, Green

Regional Availability

Availability of products, shapes, and colors may differ by region.
Application & Testing Information

Pre-assessment Testing

Ketron® LSG PEEK carries the following compliances:

  • ISO 10993-5 and USP <87> Cytotoxicity
  • ISO 10993-10 Sensitization
  • ISO 10993-10 and USP <88> Intracutaneous Reactivity
  • ISO 10993-11 and USP <88> Acute Systemic Toxicity
  • USP <88> Implantation Test
  • USP Class VI (conclusion of three of the above ISO 10993 and USP <88> tests)
  • ISO 10993-4 Human Blood Compatibility
  • USP <661> Physiochemical Testing
  • Animal Free Origin
  • Food contact - USA FDA 21 CFR § 177.2500

Please note: In some cases, different color variations of a material grade carry different approvals. Please see product documentation for details.

Intended Use

Ketron® LSG PEEK is only intended for applications in which the duration of contact with human body tissue is limited to less than 24 hours, or wetted contact applications in bioprocessing.

Furthermore, LSG materials are not intended for use in the manufacture of medical devices that will be permanently implanted in the body, nor are they intended for use in life-sustaining medical devices.

Documentation

For further regulatory documentation and absence declarations, please visit the regulatory page.