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
Status: Under development
Technical Committee: ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
- ICS :
- 11.040.20 Transfusion, infusion and injection equipment
This standard contributes to the following Sustainable Development Goal:
ISO/CD 8417Stage: 30.60
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