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Standards Development
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
The current provisions on the assessment and acceptability of particulate contamination bear a scientific rationale for acceptance. Upon intensive (literature) research and discussions, it was concluded, that no scientific rational for a per se acceptable amount of particles can be found and that any particle bears a risk for patient safety.
The NWIP intends to
- address the related clinical risks
- give further advice on the determination and acceptability assessment of particulate loads as amendment to the existing clauses in ISO 8536-4
- give 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
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