ISO 8417:2024
ISO 8417:2024 Risk management of particulate contamination for devices with intravascular access
CDN $124.00
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
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
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:
Related Documents
-
ISO 23975:2025 Traditional Chinese medicine – Priority list of single herbal medicines for developing standards
CDN $422.00 Add to cart -
ISO 17097:2024 3-D human body scan data – Methods for the processing of human body scan data
CDN $186.00 Add to cart -
ISO 1956:1982 Fruits and vegetables – Morphological and structural terminology
CDN $251.00 Add to cart -
ISO 15416:2025 Automatic identification and data capture techniques – Bar code print quality test specification – Linear symbols
CDN $336.00 Add to cart
