Medical Grade PC Resin

Medical Grade PC Resin

Medical applications demand more from a material than ordinary consumer products—beyond strength and clarity, they care about biocompatibility, sterilization tolerance, and low leachables.
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Description

Jiangsu Kingsder New Material Technology Co., Ltd. is one of the leading manufacturers and suppliers of medical grade pc resin in China. We are committed to providing high quality and UL recognized plastic raw materials to global clients. If you're going to wholesale cheap medical grade pc resin, welcome to get quotation and free sample from our factory. We also accept customized orders.

 

Description

 

Medical applications demand more from a material than ordinary consumer products-beyond strength and clarity, they care about biocompatibility, sterilization tolerance, and low leachables. Not just any clear PC can be used in healthcare; only grades that pass relevant biocompatibility evaluation and keep their properties through heat steam, ethylene oxide, or gamma sterilization qualify. Medical Grade PC Resin is designed for exactly this: it keeps PC's high impact strength, clarity, and heat resistance while putting safety, cleanliness, and sterilization stability first. Common uses include infusion sets, dialysis cartridge housings, surgical instrument handles, breathing masks, syringe components, and medical device housings.

 

Its key difference from standard PC lies in biological safety and sterilization adaptability. Medical grades undergo biocompatibility evaluation against relevant standards, looking at cytotoxicity, sensitization, and irritation, and are validated across steam, ethylene oxide, and gamma sterilization to confirm they don't degrade, yellow, or lose performance after sterilizing. Standard PC, while strong and clear, hasn't necessarily gone through this validation, so using it for medical contact parts carries risk. Medical grades also tend to emphasize low leachables and batch-to-batch consistency, which matters for regulatory compliance.

 

For grades, we offer medical-grade solutions based on imported resins such as SABIC and Covestro, as well as domestic PC from Wanhua, Daphoon, and Lihuayi, selected to your sterilization method, clarity, and application needs, and we support small trial runs and full production. Because medical materials demand strict source and batch control, we help provide relevant compliance documentation and batch traceability to support your regulatory and customer requirements.

 

Processing Medical Grade PC Resin starts with drying, the most critical step-dry it thoroughly per PC requirements to avoid appearance or property issues from moisture. Keep the molding environment clean to prevent contamination that affects cleanliness and appearance. Since the part will face sterilization, avoid introducing additives or mold-release agents that could affect biocompatibility, and use formulations suited to medical use. Between batches, keep retained samples and test records for traceability and compliance review.

 

Product Specifications

 

LEXAN™ Healthcare Resin HP1 - Polycarbonate (PC), Biocompatible (ISO 10993 / USP Class VI), EtO & Steam Sterilizable
PROPERTY TYPICAL VALUE UNIT TEST METHOD
Tensile Stress, yld, Type I, 50 mm/min 62 MPa ASTM D638
Tensile Stress, brk, Type I, 50 mm/min 65 MPa ASTM D638
Tensile Strain, brk, Type I, 50 mm/min 120 % ASTM D638
Flexural Stress, yld, 1.3 mm/min, 50 mm span 93 MPa ASTM D790
Flexural Modulus, 1.3 mm/min, 50 mm span 2300 MPa ASTM D790
Hardness, Rockwell R 118 - ASTM D785
Izod Impact, notched, 23 °C 640 J/m ASTM D256
Falling Dart Impact, 23 °C 169 J ASTM D3029
Vicat Softening Temp, Rate B/50 139 °C ISO 306
HDT, 0.45 MPa, 6.4 mm, unannealed 137 °C ASTM D648
HDT, 1.82 MPa, 6.4 mm, unannealed 126 °C ASTM D648
CTE, -40 °C to 95 °C, flow 6.84E-05 1/°C ASTM E831
Relative Temp Index, Elec 130 °C UL 746B
Density 1.19 g/cm³ ASTM D792
Water Absorption, 23 °C / 24 hrs 0.15 % ASTM D570
Mold Shrinkage, flow, 3.2 mm 0.5 – 0.7 % SABIC method
Melt Flow Rate, 300 °C / 1.2 kgf 25 g/10 min ASTM D1238
Melt Volume Rate, MVR 300 °C / 1.2 kg 23 cm³/10 min ISO 1133
Light Transmission, 2.54 mm 88 % ASTM D1003
Haze, 2.54 mm 1 % ASTM D1003
UL Recognized, 94V-2 Flame Class, 1.09 mm 94V-2 - UL 94
    *Take SABIC HP1 as an example

 

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