ISO/CD TR 8417.2
Risk management of particulate contamination for devices with intravascular access
Reference number
ISO/CD TR 8417.2
Edition 1
Committee Draft
u
ISO/CD TR 8417.2
83166
A draft is being reviewed by the committee.

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
    : CD approved for registration as DIS [30.99]
  •  : 1
  • ISO/TC 76
    11.040.20 
  • RSS updates

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This standard contributes to the following Sustainable Development Goal

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