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What is ISO 10993 Biological Evaluation Form about?

This document is a submission form for biological evaluation of medical devices according to ISO 10993-1. It requests general information about the manufacturer, product, intended use, classification based on body contact, materials used, and any changes made. The form is designed to gather necessary data to assess compliance with ISO 10993-1 for biological evaluation and testing within a risk management process. Specific documentation is requested to support topics like intended use, materials, sterilizati

Author

Jezreel Zaragosa

Language

EN