Final Draft International Standard
ISO/DTR 8417
Risk management of particulate contamination for devices with intravascular access
Reference number
ISO/DTR 8417
Edición 1
Final Draft
International Standard
ISO/DTR 8417
83166
Este borrador está en fase de aprobación.

Resumen

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.

Informaciones generales

  •  : En desarrollo
    : Texto final recibido o FDIS registrado para su aprobación formal [50.00]
  •  : 1
     : 9
  • ISO/TC 76
    11.040.20 
  • RSS actualizaciones

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