Abstract 

This document applies to medical devices that are used to provide intravascular access to patients to deliver liquids. It - addresses the related clinical risks - gives further advice on the determination and acceptability assessment of particulate loads as amendment to the existing clauses in ISO 8536-4 - gives advice on how to perform a comprehensive risk analysis on potential particle sources and how to mitigate related risks in design, manufacturing, and application of the devices


General information

  • Status :  Under development
  • Edition : 1
  • :
    ISO/TC 76
    Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

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