5 Critical Points in Metal Processing for Meeting High-Cleanliness Requirements of Medical Devices

Medical device manufacturing places extremely high demands on cleanliness, precision, and process control. To meet these standards, hardware machining must focus on several critical factors.

First, cleanroom-controlled production environments are essential. Manufacturing in a Class 100,000 cleanroom helps minimize contamination risks during machining and assembly.

Second, material safety and traceability must be strictly managed. Metals used in medical devices should meet relevant regulatory and biocompatibility requirements.

Third, surface finish and burr control are crucial. Smooth surfaces reduce contamination risks and facilitate cleaning and sterilization. Precision machining and polishing processes help achieve these standards.

Fourth, strict inspection and testing procedures—including dimensional measurement and visual inspection—ensure compliance with medical industry specifications.

Finally, process standardization and quality management, supported by ISO 9001 certification, guarantee stable and repeatable production for medical-grade components.