Ketron® LSG FG PEEKPoly-ether-ether-ketone
Ketron® LSG FG PEEK (Life Science- & Food Grade) stock shapes are made from unfilled PEEK resin that is pre-assessed for biocompatibility. The stock shapes are also 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 use in wetted contact applications in bioprocessing. Standard food approvals include the FDA 21 CFR § 177.2415, while this specific FG type has the EU 10/2011 Food Grade as an extra feature.
Ketron® LSG FG PEEK (Life Science Grade) 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. The additional food grade compliance (based on food-related extractable & leaching tests) makes this material an excellent candidate for applications in the bioprocessing fields, such as manifolds, valves, connectors, lids, and adapters.
- 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 also pre-assessed for use in wetted contact applications 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
Ketron® LSG FG PEEK stock shapes encompass a range of standard sizes in the following geometries: Rod, Plate
Ketron® LSG FG PEEK stock shapes come in the following colors: Natural (beige)
Ketron® LSG FG 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
- Food contact - EU 10/2011
- 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.
Ketron® LSG FG 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.