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ISO/TR 8417:2024
Abstract
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Summary
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
Notes
30.99 : CD approuvé pour enregistrement comme DIS
Technical characteristics
| Publisher | International Organization for Standardization (ISO) |
| Publication Date | 10/03/2024 |
| Edition | 1 |
| Page Count | 9 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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