ISO 10555-7:2023

Overview

ISO 10555-7:2023 specifies general requirements and test methods for peripherally inserted central catheters (PICC) supplied in the sterile condition and intended for single use. The standard applies to PICCs for any application but excludes intravascular catheter accessories (e.g., those covered by ISO 11070). It supplements the general ISO 10555 series by addressing PICC-specific markings, tensile testing and manufacturer information.

Key topics and technical requirements

• Scope and applicability
  • Applies to sterile, single‑use peripherally inserted central catheters (PICC).
  • Not applicable to catheter accessories covered by ISO 11070.
• Conformance
  • Catheters shall conform to ISO 10555-1 (general requirements) except where ISO 10555-7 provides alternate tensile requirements.
• Distance markings
  • If provided, distance marking system must indicate catheter length; distance between marks shall not exceed 5 cm from the first mark.
• Lumen markings
  • For multi‑lumen PICCs, each lumen must be clearly identifiable; for staggered tips the relative position of distal openings must be apparent.
• Peak tensile force (shaft and tip)
  • Test method follows ISO 10555‑1; tensile requirement values are specified in ISO 10555‑7.
  • For silicone catheters (excluding tip), minimum peak tensile force depends on effective outside diameter:
    • ≥ 0.75 mm and < 1.15 mm → 1.6 N
    • ≥ 1.15 mm and < 1.85 mm → 3.4 N
  • Tip tensile force (tips ≤ 20 mm): silicone tips follow Table 1; non‑silicone tips follow Table 2:
    • Smallest catheter OD ≥ 0.55 and < 0.75 mm → 3 N
    • ≥ 0.75 and < 1.85 mm → 4 N
    • ≥ 1.85 mm → 5 N
  • Tubing < 0.75 mm OD: peak tensile force is determined by the manufacturer via risk assessment.
• Manufacturer information
  • Information shall conform to ISO 10555‑1 and ISO 10555‑3 and must indicate, for each lumen, whether it is compatible with power injection.

Practical applications and users

• Medical device manufacturers designing and testing PICC lines will use ISO 10555‑7 to:
  • Validate tensile strength, tip integrity and marking systems.
  • Prepare regulatory and technical documentation.
• Test laboratories and quality assurance teams apply the specified test methods and performance limits.
• Regulatory authorities and notified bodies reference the standard for conformity assessment and market approval.
• Clinical procurement, vascular access teams and biomedical engineers use the standard to compare product specifications, especially for sterile single‑use catheters and power injection compatibility.

Related standards

• ISO 10555-1 - Intravascular catheters: General requirements and test methods
• ISO 10555-3 - Central venous catheters
• ISO 11070 - Sterile single‑use intravascular introducers, dilators and guidewires

Keywords: ISO 10555-7, PICC, peripherally inserted central catheters, sterile single-use catheters, tensile force, lumen markings, distance markings, power injection compatibility.