ISO 10555-6:2015 PDF

Overview

ISO 10555-6:2015 - Intravascular catheters - Part 6: Subcutaneous implanted ports - specifies requirements, performance criteria, and user-safety considerations for sterile, single‑use subcutaneous implanted ports and their catheters intended for long‑term intravascular access. The standard applies to devices supplied sterile and intended for single use; it explicitly excludes specifying requirements related to non‑coring needles. ISO 10555-6 is part of the ISO 10555 series covering sterile single‑use intravascular catheters.

Key topics and technical requirements

• Scope and definitions: Clarifies terms such as reservoir, septum, priming and flushing volumes, outlet tube, and effective surface area.
• Biocompatibility: Devices shall be free from biological hazards; ISO 10993‑1 is referenced for test selection.
• Physical requirements:
  • Radio‑detectability: Port, catheter and connections must comply with ISO 10555‑1 radio‑detectability rules.
  • Surface finish: Visual inspection (≥×2.5 magnification) for absence of extraneous matter.
  • Freedom from leakage: Leakage tests in Annex A and D; leakage considered unacceptable if pressure drop > 2.65 kPa in 2 min or if 200 kPa cannot be attained.
  • Septum characteristics: Guidance on needle penetration and withdrawal forces (Annex C) and resistance to multiple punctures (Annex D).
  • Connection strength: Minimum peak tensile force for port–catheter connection is 5 N (Annex E).
• Fluid performance:
  • Flow rate: Minimum measured flow per lumen must be ≥80% of manufacturer claim for catheters