Final Draft International Standard
ISO/DTR 8417
Risk management of particulate contamination for devices with intravascular access
Reference number
ISO/DTR 8417
Edition 1
Final Draft
International Standard
ISO/DTR 8417
83166
This draft is in the approval phase.

Abstract

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.

General information

  •  : Under development
    : Final text received or FDIS registered for formal approval [50.00]
  •  : 1
     : 9
  • ISO/TC 76
    11.040.20 
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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