ISO/NP 8417

Risk management of particulate contamination for devices with intravascular access

General information

Current stage: 10.60 Effective date: 8 sht 2021

Originator: ISO

Owner: ISO/TC 76

Type: International Standard

Scope

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

Life cycle

NOW

IN_DEVELOPMENT
ISO/NP 8417
10.60 Close of voting
8 sht 2021

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