タグ: ISO13485
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CNC Machining Of Medical Implants, ISO13485 Tolerance Control Guide
Question: Medical implants (such as orthopedic bone plates, acetabular cup trial molds) require a dimensional tolerance of ±0.005mm, a surface roughness Ra≤0.4μm, and no burrs or cutting residues. How to establish processing specifications that meet FDA/QMS requirements?