Publikuar
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.
PUBLISHED
ISO/TR 8417:2024
60.60
Standard published
3 tet 2024
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.
English