CEN - EN ISO 10555-6
Intravascular catheters — Sterile and single-use catheters — Part 6: Subcutaneous implanted ports
| Organization: | CEN |
| Publication Date: | 1 August 2017 |
| Status: | active |
| Page Count: | 28 |
| ICS Code (Syringes, needles and catheters): | 11.040.25 |
scope:
This part of ISO 10555 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use.
This part of ISO 10555 does not specify requirements, performance, and user safety issues related to non-coring needles.
NOTE Subcutaneous implanted ports are known to be used for indications other than intravascular such as intra-peritoneal, intra-thecal, intra-pleural, and epidural access.
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