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
IN_DEVELOPMENT
ISO/CD 8417
30.20
CD study/ballot initiated
Nov 21, 2022
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