ISO/TR 8417:2024

Current Revision
Risk management of particulate contamination for devices with intravascular access

Best Price Guarantee Published: Jan 1, 2024 en - English 16 Pages

Sub Total (1 Item(s)) $ 0.00
Estimated Shipping $ 0.00
Total (Pre-Tax) $ 0.00
View in Library
or
International Organization for Standardization Logo

Risk management of particulate contamination for devices with intravascular access

PUBLISH DATE 2024

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.

Loading...

Failed to load document history.

Publish Date Document Id Type View