BS PD ISO/TR 8417:2024
Risk management of particulate contamination for devices with intravascular access
BSI Group , 10/31/2024
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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.
— 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.
Product Information
Published:
10/31/2024
Pages:
18
ISBN:
9780539194845
File Size:
1 file , 1.4 MB
Language:
English
Note:
This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus
