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## Why Medical Stamping Is Different
Medical device components (surgical instrument parts, implant components, catheter fittings) require tolerances and traceability that exceed typical industrial stamping.
## Typical Requirements
- Dimensional tolerance: +/-0.005-0.02mm on critical features
- Surface finish: Ra 0.4-0.8 μm (no burrs, no scratches)
- Material: 316L stainless steel, titanium, cobalt-chrome alloys
- Traceability: every part must be traceable to material lot and press parameters
- Validation: IQ/OQ/PQ required for FDA-regulated devices
## Press Requirements
To achieve +/-0.005mm tolerances:
- BDC repeatability: +/-0.002mm or better
- Slide parallelism: 0.003mm per 300mm
- Temperature-compensated position control (thermal expansion affects accuracy)
- Direct-drive servo press only (gear reducers introduce backlash)
## Process Control
**100% tonnage monitoring:** Every stroke must be within +/-3% of nominal. Out-of-tolerance strokes trigger automatic part rejection.
**Parameter logging:** Press must log slide position, velocity, and tonnage for every stroke. Data retained for device lifetime (typically 10+ years).
**Die qualification:** New dies require 300-stroke qualification run before production. Statistical analysis of all 300 strokes.
## Recommended Presses
For medical stamping at 10-50T:
- Aida DSF-N1 series (direct drive, +/-0.002mm BDC)
- Bruderer BSTA (high-speed, excellent for small parts)
For 50-200T medical components:
- Aida DSF-N1-200
- Schuler MSP series