Sky Bear Technical Standards - Home
Search
×
FR

Placeholder headline

This is just a placeholder headline

B51-14 (R2019) – Boiler, pressure vessel, and pressure piping code

$

362

BUY NOW

ISO 8417:2024

ISO 8417:2024 Risk management of particulate contamination for devices with intravascular access

CDN $130.00

SKU: 338107f5eb2f Categories: ,

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.

Edition

1

Published Date

2024-10-03

Status

PUBLISHED

Pages

9

Language Detail Icon

English

Format Secure Icon

Secure PDF

Abstract

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.

Previous Editions

Can’t find what you are looking for?

Please contact us at: