ISO - DIS 8417
Risk management of particulate contamination for devices with intravascular access
pending, Most Current
| Organization: | ISO |
| Publication Date: | 19 October 2023 |
| Status: | pending |
| Page Count: | 16 |
| ICS Code (Transfusion, infusion and injection equipment): | 11.040.20 |
scope:
This document is applicable to medical devices that are used to provide intravascular access to patients to deliver liquids. This document
- document the state of the art of contamination control
- specifies the determination of particulate loads
- gives guidance on how to perform a comprehensive risk analysis on potential particle sources and how to control related risks in design, manufacturing, and application of devices.
Document History
DIS 8417
October 19, 2023
Risk management of particulate contamination for devices with intravascular access
This document is applicable to medical devices that are used to provide intravascular access to patients to deliver liquids. This document
— document the state of the art of contamination control
—...