Overview
EN ISO 10555-5:2013 (ISO 10555-5:2013) specifies requirements for over-needle peripheral intravascular catheters - sterile, single‑use catheters used to access the peripheral vascular system. Published by CEN/ISO, this part of the ISO 10555 series focuses on the design, physical properties, and essential manufacturer information for catheters that are introduced over a rigid needle (over-needle systems).
Key topics and technical requirements
- Scope and conformity
- Applies to sterile, single‑use over-needle peripheral catheters; complements ISO 10555-1 (general requirements).
- Materials and needle construction
- Steel needle tubing used must comply with ISO 9626.
- Needle points must appear sharp and free from burrs under 2.5× magnification; non‑coring point geometries are recommended (Annex C).
- Dimensional and fit requirements
- Distal catheter tip must be tapered and fit closely to the needle. When needle is fully inserted, the catheter must not extend beyond the heel of the needle bevel and must be no more than 1 mm from it.
- Flashback and needle hub
- The needle hub (or equivalent) must permit detection of flashback (blood entry) and communicate with the needle bore. Removable vent fittings require a female 6% (Luer) taper compliant with ISO 594-1 (soon to be superseded by ISO 80369-7).
- Vent fitting and leakage
- A vent fitting is required; fluid shall not leak out of the vent fitting within 15 s when tested per Annex D.
- Mechanical integrity
- Union between needle tube and needle hub must withstand tests in Annex A without loosening.
- Colour coding and sizing
- Catheter hubs or fittings shall be colour coded per Table 1 to indicate nominal outside diameter (examples: 0.6 mm – violet, 1.0 mm – pink, 2.5 mm – red, 3.3 mm – light brown). Annex B provides suggested opaque colour references.
- Labelling and manufacturer information
- Manufacturer must supply flowrate for each lumen, a warning against re‑inserting withdrawn needles, and the colour code/outside diameter on primary packaging.
- Multilumen identification
- Each lumen of multilumen catheters must be readily identifiable to the user.
Applications and users
- Intended audience: medical device manufacturers, product designers, quality/validation engineers, test laboratories, regulatory affairs professionals, hospital procurement teams, and clinicians evaluating catheter specifications.
- Practical uses: design verification, production quality control, regulatory compliance for CE marking, procurement specifications, and clinical device selection for peripheral IV access.
Related standards
Keywords: EN ISO 10555-5:2013, ISO 10555-5:2013, over-needle peripheral catheters, intravascular catheters, sterile single-use catheters, catheter colour code, needle hub, vent fitting, Luer taper.
