Risk management of particulate contamination for devices with intravascular access

Risk management of particulate contamination for devices with intravascular access

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1   Scope

This document
  • — provides information on the determination of particulate loads;
  • — reports on established methods for a comprehensive risk analysis on potential particle sources and related risks in design, manufacturing, and application of devices.
This document is applicable to medical devices that are used to provide intravenous access to patients to deliver 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.