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)