Overview
EN ISO 10555-6:2017/A1:2019 is Amendment 1 to the international standard ISO 10555-6 (Part 6) covering subcutaneous implanted ports - a class of sterile, single‑use intravascular catheters. Endorsed by CEN and published in October 2019, this amendment updates specific performance requirements for flow-rate verification and clarifies test conditions for certain catheter types.
Key topics and technical requirements
- Scope: Applies to sterile, single‑use intravascular catheters in the form of subcutaneous implanted ports (EN ISO 10555-6).
- Flow‑rate acceptance criteria (clause 4.6 amended):
- For devices where a flow rate is defined, testing shall follow:
- Minimum flow rates per lumen:
- ≥ 80% of the flow stated in the Instructions for Use (IFU) for catheters with nominal outside diameter (OD) less than 1.0 mm.
- ≥ 90% of the flow stated in the IFU for catheters with nominal OD equal to or greater than 1.0 mm.
- Hydratable catheters: If flow is measured for hydratable materials, the flow rate must be determined in the post‑hydration state (i.e., after the catheter has been hydrated according to its intended use).
- Standards adoption: The amendment is an ISO update adopted as a European standard (EN ISO) and is to be implemented by CEN member bodies.
Practical applications and who uses it
This amendment is relevant to stakeholders involved in the design, manufacture, testing, procurement and clinical use of implanted vascular access ports:
- Medical device manufacturers - for product design validation, IFU claims, bench testing and regulatory compliance.
- Independent test laboratories - to perform flow performance testing in accordance with ISO 10555-1 Annexes E and G and to report results against the 80/90% acceptance criteria.
- Regulatory and quality teams - to demonstrate conformity with internationally harmonized performance requirements for submission and certification.
- Hospital procurement and clinical engineers - to evaluate device performance claims (e.g., suitability for power injection).
- Clinicians and interventional radiologists - beneficial for understanding performance limits and safe use for infusion and power injection procedures.
Related standards
- ISO 10555-1:2013 - General test methods and requirements referenced for flow testing (Annex E and Annex G).
- Other parts of the ISO 10555 series - provide complementary requirements for different catheter types and test methods.
Keywords: EN ISO 10555-6:2017/A1:2019, ISO 10555-6, subcutaneous implanted ports, intravascular catheters, sterile single-use catheters, flow rate, power injection, hydratable catheters, medical device standards, catheter testing.
