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    What is Medical Grade Polycarbonate

    2025-06-12 14:46:55  News

    1. Definition of medical grade polycarbonate

    Medical grade PC plastic, full name medical grade polycarbonate (Polycarbonate, PC), is an engineering plastic designed specifically for medical equipment, instruments and packaging applications.

    Biocompatibility: Passed ISO 10993 series tests (including cytotoxicity, hemolysis, skin irritation, etc.).

    Sterilization adaptability: Withstands gamma rays, ethylene oxide (EO), high temperature steam (up to 143°C) and electron beam sterilization without performance degradation.

    Regulatory certification: Complies with FDA 21 CFR, EU MDR, YY/T 0806-2010 (China Medical PC Special Material Standard)

     

    2. Main production countries and representative models

    1. Germany (Covestro)

    APEC® PC 1805: High viscosity (MVR 6.5–16 g/10min), anti-yellowing due to gamma radiation, suitable for surgical instruments and artificial organs.

    Makrolon® PC2407 RE: low viscosity (MVR 19 cm³/10min), bio-based ingredients, easy demoulding, used for syringes and breathing valves.

    Makrolon® PC 2658: medium viscosity, chemical resistance, 90% light transmittance, suitable for steam sterilized dialysis parts.

    DP1-1262: high impact resistance (notch impact 65 kJ/m²), high temperature resistance (HDT 135℃), used for dialysis machine housing.

    2. China (Wanhua Chemical)

    CLARNATE® MR series: radiation-resistant grade, registered through NMPA master file, used in hemodialyzers and oxygenators, with outstanding anti-yellowing performance.

    3. Other countries

    Niron Chemical (China): launched aliphatic polycarbonate TPU (NLMD65 series) for implanted catheters with excellent biocompatibility.

     

    3. Core performance characteristics

    High transparency and optical properties

    The light transmittance is 87–90%, close to glass, which is convenient for medical operation observation (such as blood flow monitoring).

    Mechanical strength and durability

    High impact resistance (notched impact strength 8–65 kJ/m²), low-temperature toughness is maintained well (-30℃ impact 14 kJ/m).

    Flexural modulus 2350–2500 MPa, supporting precision structural design.

    Chemical and sterilization resistance

    Resistant to hydrolysis, alcohol/disinfectant, and stable physical properties after repeated sterilization.

    Lightweight processability

    Density 1.20 g/cm³, injection molding temperature 280–320℃, suitable for thin-walled complex parts (such as minimally invasive devices)

     

    4. Typical application areas

    Life support equipment

    Hemodialyzer/oxygenator: PC is resistant to radiation sterilization, and the transparency meets the needs of real-time monitoring.

    Artificial organs: APEC® 1805 is used for artificial kidney and artificial lung shells, and the biocompatibility meets the standards.

    Surgical and diagnostic equipment

    Endoscope components: PC 2658 has high light transmittance and is resistant to steam sterilization, suitable for high-temperature sterilization environments.

    Syringes/infusion valves: PC 2407 RE has low viscosity and is easy to mold, and meets FDA food contact standards.

    Protection and consumables

    Protective masks/goggles: use high impact resistance (such as DP1-1262) and anti-fog coatings.

    Laboratory equipment: culture dishes, centrifuge tubes (resistant to gamma ray sterilization)


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