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  • ISO
    ISO/TR 8417:2024 Risk management of particulate contamination for devices with intravascular access
    Edition: 2024
    $192.38
    / user per year

Content Description

This document

—     provides information on the determination of particulate loads;

—     reports on established methods for a comprehensive risk analysis on potential particle sources and related risks in design, manufacturing, and application of devices.

This document is applicable to medical devices that are used to provide intravenous access to patients to deliver liquids.

NOTE            For routes of administration that are not intravenous, the information in this document might be relevant to assist in the identification of sources of potential particulate contamination.



The following editions for this book are also available...

Format Year Publisher Type Title Annual Price
2024
BSI
Standards
 $336.12 Buy

About ISO

ISO, the International Organization for Standardization, brings global experts together to agree on the best way of doing things – for anything from making a product to managing a process. As one of the oldest non-governmental international organizations, ISO has enabled trade and cooperation between people and companies all over the world since 1946. The International Standards published by ISO serve to make lives easier, safer and better.
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