Core Requirements for Medical Device Plastic Injection Molding

Medical device plastic injection molding is a high-precision, specialized injection molding process for the medical field. The core requirements for medical device plastic injection molding can be summarized in the following four dimensions:

1. Biosafety and Material Compliance: All raw materials must pass ISO 10993 series biocompatibility tests. Strict control must be exercised over toxic monomers, oligomers, and residual metal ions such as lead and cadmium. Medical-grade compliant materials such as PP, PEEK, and PPSU are preferred to avoid additive leaching that could affect safety.

2. Micron-Level High-Precision Control: Tolerances for key components must be controlled within ±0.005~±0.01mm, with a surface roughness Ra≤0.28um. A fully electric closed-loop servo injection molding machine is used to control injection pressure fluctuations within ±1%, ensuring product weight variation is less than 0.1%.

3. Clean Production Environment Management: Conventional Class II products must be produced in an ISO 7 cleanroom. Implantable products must be upgraded to an ISO 5 laminar flow environment. Strict control must be exercised over the number of particulates and settling bacteria, cutting off the source of contamination throughout the entire process.

4. Full-process compliance and traceability: It must comply with the requirements of ISO 13485, China's medical device GMP and other systems. Information such as molds, production batches and operators must be recorded throughout the process. All production data is traceable and meets the compliance requirements of drug regulatory inspections.

Qingdao Xueyu Molding Products Co., Ltd. is mainly engaged in the design and manufacturing of injection molds, injection molding and secondary processing (spraying, pad printing, ultrasonic welding, stamping), etc. For more information about medical device plastic injection molding, please contact us.

Website: www.xyzmould.com

Address: No.18 Henan Head Road, Henan Head Community, Jihongtan Street, Qingdao Industrial Park, Shandong Province, China

Email: wangmiaotian8@163.com