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13485

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ISO 13485 Requirements for Medical CNC Parts: A Comprehensive Analysis from Material to Inspection

ISO 13485:2016 is the core compliance standard for medical CNC parts to enter the global market. Its key requirements focus on three aspects: material compliance (biocompatibility, traceability), production process control (clean environment, precision control, UDI marking), and full-process inspection (dimension, performance, compliance records). It aims to ensure the safety and effectiveness of parts through full-lifecycle risk management, meeting international market access requirements.

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