Technical Report
ISO/TR 8417:2024
Risk management of particulate contamination for devices with intravascular access
Reference number
ISO/TR 8417:2024
Edition 1
2024-10
Technical Report
Preview
ISO/TR 8417:2024
83166
Indisponible en français
Publiée (Edition 1, 2024)

ISO/TR 8417:2024

ISO/TR 8417:2024
83166
Langue
Format
CHF 63
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Résumé

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.

Informations générales

  •  : Publiée
     : 2024-10
    : Norme internationale publiée [60.60]
  •  : 1
  • ISO/TC 76
    11.040.20 
  • RSS mises à jour

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