ISO 10555-5:2013

Overview

ISO 10555-5:2013 specifies requirements for over-needle peripheral intravascular catheters - sterile, single-use devices used to access the peripheral vascular system. This part of the ISO 10555 series focuses on the design, physical characteristics, testing and manufacturer information for over-needle peripheral catheters and their introducer needles.

Key topics and technical requirements

• Scope & definitions: Identifies terms such as catheter unit, needle tube, needle hub, vent fitting and flashback.
• Material and needle requirements: If steel needle tubing is used it shall comply with ISO 9626. Needle points must appear sharp and free from burrs under ×2.5 magnification and be designed to be non‑coring (Annex C describes typical geometries).
• Physical design:
  • The catheter distal end must be tapered and fit closely to the needle (needle fully inserted must not let catheter extend beyond heel of bevel or be more than 1 mm away).
  • Colour coding: Hubs or fittings must be colour coded per Table 1 to indicate nominal outside diameter (corresponding gauge numbers optionally listed).
  • Multilumen catheters must clearly identify each lumen.
• Performance tests:
  • Needle hub/tube union strength (Annex A): tensile/compressive testing - needles <0.6 mm use 10 N; ≥0.6 mm use 20 N; tube must not loosen in the hub.
  • Vent fitting leakage (Annex D): simulated blood under hydrostatic head; no fluid leak from vent fitting within 15 seconds.
• Information to be supplied by manufacturer: flowrate for each lumen, warning against re‑inserting a partially or completely withdrawn needle, and colour code and outside diameter on each primary package (unless visible).

Applications and who uses this standard

ISO 10555-5 is essential for:

• Medical device manufacturers - product design, material selection, assembly and production QA for over-needle peripheral catheters.
• Test laboratories and quality control - conducting the normative strength and leakage tests specified in Annexes A and D.
• Regulatory and compliance teams - preparing technical files and ensuring labeling, sterile single‑use claims, and packaging meet requirements.
• Procurement and clinical engineering - specifying supplier requirements and selecting devices that meet standardized safety and performance criteria.
• Healthcare professionals - understanding device characteristics relevant to use, compatibility and safety (e.g., flashback detection, vent function).

Related standards (selected)

• ISO 10555-1 (General requirements for sterile single‑use intravascular catheters)
• ISO 9626 (Stainless steel needle tubing)
• ISO 11070 (Introducers for intravascular catheters)
• ISO 14972 (Sterile obturators for over-needle catheters)
• ISO 594-1 / IEC 80369-7 (Luer taper and small-bore connector standards)

Keywords: ISO 10555-5, over-needle peripheral catheters, intravascular catheters standard, sterile single-use catheters, catheter color coding, needle hub strength, vent fitting leakage, medical device manufacturing, quality control tests.