ISO/DIS 8417

Status : Under development

	Format	Language
std 1 61	PDF
std 2 61	Paper

CHF61

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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

Status
: Under development

You can help develop this draft international standard by contacting your national member

Stage
: DIS ballot initiated: 12 weeks [40.20]
Edition
: 1

Number of pages
: 9
Technical Committee :
ISO/TC 76

ICS :
11.040.20
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