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PS 3860-4-2026
Active
Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters
Committee:
Medical Devices and Supplies
Sector:
Health and Personal Care
Available Standards
Original Standard
Not Specified
25
Page
2026
International Classification for Standards (ICS)
| Code | Classification |
|---|---|
| 11.040.25 | Syringes, needles and catheters |
Adopted Standards
| Standards / Amendment / Corrigendum | |
|---|---|
| 1 | ISO 10555-4:2023 |
Replacement Sequence
| Replaces |
|---|
| PS 3860-4-2021 |
Scope
This document specifies requirements for balloon dilatation catheters supplied sterile and intended for single use.
This document does not specify requirements for vascular stents (see ISO 25539-2).
NOTE Guidance on the selection of balloon materials is given in Annex G.