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
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Status: Under developmentYou can help develop this draft international standard by contacting your national memberStage: DIS ballot initiated: 12 weeks [40.20]
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Edition: 1Number of pages: 9
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Technical Committee :ISO/TC 76ICS :11.040.20
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