Makrolon Rx1805

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-freeAwaiting confirmation
• Phthalate-freeAwaiting confirmation
• BPA-freeNo
• 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 Makrolon Rx1805 be autoclaved?

Not for repeat cycles. Saturated steam hydrolyses polycarbonate, causing embrittlement and crazing over repeated exposure, and at 134 °C the cycle temperature also exceeds this grade's 126 °C HDT at 1.80 MPa, so parts may distort under load. If your device needs steam sterilization, look at a polysulfone such as Udel P-1700 or a PPSU such as Radel R-5500. This is an engineering assessment drawn from the grade's own thermal data, not a producer statement.

How does Makrolon Rx1805 hold up to gamma sterilization?

This grade is radiation-stabilized specifically for gamma service, which is its primary intended sterilization route. It retains clarity and impact strength far better than general-purpose polycarbonate, which yellows noticeably. Some dose-dependent colour shift still occurs. We do not hold a maximum dose figure, so confirm the qualified dose range with Covestro for your cycle.

Is Makrolon Rx1805 BPA-free?

No. All polycarbonate is polymerised from bisphenol A, so no PC grade can be BPA-free. Residual free monomer is controlled by the producer's specification. If a BPA-free claim is a hard requirement, consider a cyclic olefin polymer such as Zeonex 690R or a polyester-based alternative.

What body contact duration is Makrolon Rx1805 qualified for?

The grade record classifies it for limited contact, meaning 24 hours or less under ISO 10993-1, and it carries USP Class VI along with ISO 10993-4 and -5 testing. For prolonged or permanent contact you need a grade with a matching dossier — Pellethane 2363-80A covers prolonged contact and Zeniva ZA-500 PEEK covers permanent implant use.

Can Makrolon Rx1805 be wiped down with isopropyl alcohol or CaviCide?

Brief wipe-down is generally tolerated, but polycarbonate is prone to environmental stress cracking in alcohols and quat disinfectants. The risk rises sharply where the part carries moulded-in stress or an applied load. Qualify the actual part with your cleaning protocol rather than relying on a resin-level rating, and design to keep stress out of surfaces that will be wiped.

How should Makrolon Rx1805 be dried before moulding?

Published guidance is 120 °C for two to three hours in a dry-air dryer, targeting a maximum moisture content of 0.02% before processing. Polycarbonate hydrolyses in the melt if moulded wet, which shows up as splay and reduced impact strength. These figures are machine-extracted and pending review, so confirm against the current TDS.