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PS 3860-6-2026
Active
Intravascular catheters — Sterile and single-use catheters — Part 6: Subcutaneous implanted ports
Committee:
Medical Devices and Supplies
Sector:
Health and Personal Care
Available Standards
Original Standard
Not Specified
29
Page
2026
International Classification for Standards (ICS)
| Code | Classification |
|---|---|
| 11.040.25 | Syringes, needles and catheters |
Adopted Standards
| Standards / Amendment / Corrigendum | |
|---|---|
| 1 | ISO 10555-6:2015 |
| 2 | Amd 1:2019 |
Replacement Sequence
| Replaces |
|---|
| PS 3860-6-2021 |
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.