Medical Mold Requirements — ISO 13485 and Clean Room

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Medical mold requirements are strict:

ISO 13485 certification — Required for medical device manufacturers
Clean room molding (Class 7/8) — Dust control for medical parts
Material traceability — Full documentation from resin to final part
Validation — IQ/OQ/PQ protocols required
Surface finish — Typically SPI A1 or A2 mirror finish

Medical mold costs 30-50% more than standard molds due to certification and documentation requirements.

Full guide: https://www.mfgabc.com/guides/medical-mold-standards.html

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