• BS PD ISO/TR 8417:2024

BS PD ISO/TR 8417:2024

Risk management of particulate contamination for devices with intravascular access

BSI Group , 10/31/2024

Publisher: BS

File Format: PDF

$95.00$191.00


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.

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