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BS PD ISO/TR 8417:2024
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Risk management of particulate contamination for devices with intravascular access
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Full Description
This document— provides information on the determination of particulate loads;
— reports on established methods for a comprehensive risk analysis on potential particle sources andrelated risks in design, manufacturing, and application of devices.
This document is applicable to medical devices that are used to provide intravenous access to patients todeliver liquids.
NOTE: For routes of administration that are not intravenous, the information in this document might be relevant to assist in the identification of sources of potential particulate contamination. See more
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Risk management of particulate contamination for devices with intravascular access