DPS
Drejtoria e Përgjithshme e Standardizimit
0 Items
My account
E-albania
Phone: +355 4 222 62 55
E-mail: info@dps.gov.al
Address: Address: "Reshit Collaku" Str., (nearby ILDKPKI, VI floor), Po.Box 98, Tiranë - Albania
Main menu

ISO/NP 8417

Risk management of particulate contamination for devices with intravascular access

General information

10.60     Sep 8, 2021

ISO

ISO/TC 76

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
Sep 8, 2021

Preview

Only informative sections of projects are publicly available. To view the full content, you will need to members of the committee. If you are a member, please log in to your account by clicking on the "Log in" button.

Login