Grades of Medical-Grade Plastic Particles
Medical-grade plastic particles are indispensable materials in the manufacturing of medical devices. Their quality is directly related to the safety and effectiveness of medical devices. To ensure the quality of medical devices, medical-grade plastic particles need to undergo strict grading and management.
1. Biosecurity Level
Class I (Non-contact): Such as PP medicine bottles, which need to pass the USP Class VI skin irritation test.
Class II (Short-term contact): PC breathing masks, requiring cytotoxicity ≤ 2 (MTT assay).
Class III (Long-term implantation): PEEK orthopedic devices, which need to complete ISO 10993-10 genotoxicity certification.
2. Sterilization Adaptability Classification
Gamma Irradiation Grade: Can withstand a dose of 25kGy, used for disposable syringes.
Autoclave Sterilization Grade: The material needs to maintain dimensional stability under 134℃/18min conditions (such as PPSU dialyzers).
EtO Ethylene Oxide Resistance Grade: Requires that the residual monomer content < 0.1ppm.
3. Traceability Management Level
GMP Grade: Provides DIN EN ISO 13485 material certificate for all batches.
Pharmaceutical Grade: In line with FDA 21 CFR 177.2600 standard resin batch control.
