Pellethane 2363-80A

Ratings describe the resin's general behaviour, not your part. Moulded-in stress, wall section, temperature and applied load all change the outcome — qualify the finished device with your own cleaning and exposure protocol.

Maximum dose and cycle counts require producer validation data, so we show "Confirm with producer" rather than a figure. Retention and discoloration notes are qualitative. Sterilization must always be validated on the finished device.

• USP Class VIYes
• ISO 10993-1 (biological evaluation)Yes
• ISO 10993-4 (blood interaction)Yes
• ISO 10993-5 (cytotoxicity)Yes
• ISO 10993-6 (implantation)Yes
• ISO 10993-10 (irritation / sensitization)Yes
• ISO 10993-11 (systemic toxicity)Yes
• FDA Drug Master FileYes
• EU MDR statusAwaiting confirmation
• Food contact statusAwaiting confirmation
• REACH SVHCAwaiting confirmation
• RoHSAwaiting confirmation
• Animal-derived-free / TSE-BSEYes
• DEHP-freeYes
• Phthalate-freeYes
• BPA-freeYes
• Latex-freeYes
• California Prop 65Awaiting confirmation

Compliance status reflects producer statements and grade records on file. Always confirm the current position with a signed regulatory statement letter for your specific device and market before submission.

Cross-references indicate a similar material family, not a guaranteed drop-in. Qualify any substitution against your own part and process.

Can Pellethane 2363-80A be autoclaved?

No. An 80A thermoplastic polyurethane has no meaningful load-bearing stiffness at 121–134 °C, so parts soften and distort, and saturated steam also hydrolyses the urethane linkage. Ethylene oxide is the conventional route for this material, and gamma and e-beam are both listed as compatible.

Why choose a polyether TPU over a polyester TPU for catheters?

Hydrolytic stability. The polyether soft segment resists hydrolysis in blood and saline, whereas a polyester-based TPU degrades over prolonged wet contact. For an indwelling device that stays in the body for days or weeks, that difference decides whether the shaft retains its strength.

Is Pellethane 2363-80A DEHP-free and phthalate-free?

Yes. Thermoplastic polyurethane gets its softness from its own soft-segment chemistry rather than an added plasticiser, so there is no DEHP or other phthalate to leach out. This is the main reason TPU is specified in place of plasticised PVC for paediatric and neonatal fluid paths, where phthalate restrictions are tightening.

What body contact duration is Pellethane 2363-80A qualified for?

The grade record classifies it for prolonged contact, meaning 24 hours to 30 days under ISO 10993-1, and it carries USP Class VI along with ISO 10993 parts 4, 5 and 11. Part 4 haemocompatibility is the critical package for blood-contacting devices. For permanent implant contact beyond 30 days you would need an implant-grade material such as Zeniva ZA-500 PEEK.

How does Pellethane 2363-80A behave after gamma sterilization?

It is listed as gamma compatible and is generally well tolerated at single-dose device levels. Expect some cross-linking, which can slightly stiffen the material, and mild dose-dependent yellowing of the natural translucent colour. We do not publish a maximum dose here — confirm the qualified range with Lubrizol, particularly if the part is dimensionally or optically critical.

Will lipids or lipid-based infusions affect Pellethane tubing?

Over prolonged contact, yes. Lipids can be absorbed into the soft segment, causing swelling and some softening. It is worth qualifying specifically if the line will carry lipid emulsions such as parenteral nutrition. For short-duration contact the effect is minor.