Medical Mold Requirements — ISO 13485 and Clean Room

[adminmo 2]

<p>Medical mold requirements are strict:</p>

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

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

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

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