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ISO/CD TR 8417.2

Risk management of particulate contamination for devices with intravascular access ISO/CD TR 8417.2

General information

30.99 CD approved for registration as DIS   Apr 26, 2024

ISO

ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

Technical Report

11.040.20   Transfusion, infusion and injection equipment

Buying

Under development

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Scope

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

Life cycle

NOW

IN_DEVELOPMENT
ISO/CD TR 8417.2
30.99 CD approved for registration as DIS
Apr 26, 2024