ISO/DIS 8417
u
ISO/DIS 8417
83166
Status : Under development
en
Format Language
std 1 61 PDF
std 2 61 Paper
  • CHF61
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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

  •  : Under development
    You can help develop this draft international standard by contacting your national member
    : DIS ballot initiated: 12 weeks [40.20]
  •  : 1
     : 9
  • ISO/TC 76
    11.040.20 
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Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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