ISO/TR 8417:2024

International Standard   Current Edition · Approved on 03 October 2024

Risk management of particulate contamination for devices with intravascular access

ISO/TR 8417:2024 Files

English 9 Pages
Current Edition
80.38 USD

ISO/TR 8417:2024 Scope

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.

Best Sellers

GSO 150-2:2013
 
Gulf Standard
Expiration dates for food products - Part 2 : Voluntary expiration dates
YSMO GSO 150-2:2020
GSO 150-2:2013 
Yemeni Technical Regulation
Expiration dates for food products - Part 2 : Voluntary expiration dates
YSMO GSO 2055-1:2020
GSO 2055-1:2015 
Yemeni Standard
HALAL FOOD - Part 1 : General Requirements
GSO 2055-1:2015
 
Gulf Technical Regulation
HALAL FOOD - Part 1 : General Requirements

Recently Published

ISO 13909-8:2025
 
International Standard
Coal and coke — Mechanical sampling — Part 8: Methods of testing for bias
ISO/IEC 16466:2025
 
International Standard
Information technology — 3D printing and scanning — Assessment methods of 3D scanned data use in 3D printing
ISO 18960:2025
 
International Standard
Security controls and implementation for third party payment service providers — Guidance and requirements
ISO 5684:2025
 
International Standard
Adhesives — Floor covering adhesives and products for flooring installation — Assessment and classification of low volatile organic compound (VOC) products