Overview
EN ISO 10555-6:2017 (ISO 10555-6:2015) specifies requirements, performance and user-safety provisions for sterile, single‑use subcutaneous implanted ports and their intravascular catheters intended for long‑term vascular access. The standard covers design, marking, packaging, testing and information to be supplied by manufacturers. It does not cover requirements for non‑coring needles.
Keywords: ISO 10555-6, EN ISO 10555-6:2017, subcutaneous implanted ports, intravascular catheters, sterile single‑use catheters.
Key topics and technical requirements
- Scope and applicability - Devices for long‑term intravascular use supplied sterile and for single use. Excludes non‑coring needles.
- Biocompatibility - Requirements to address material safety for implanted port components.
- Physical requirements - Includes radio‑detectability, surface finish, freedom from leakage, flushing volume and septum characteristics.
- Connection and catheter characteristics - Specifications for the port–catheter connection and catheter dimensions.
- Flow rate and burst pressure - Clauses distinguish devices indicated for routine infusion vs. those indicated for power injection (high‑pressure injection), with related flow and burst pressure considerations.
- MRI compatibility - Requirements and guidance for assessing device behaviour in magnetic resonance imaging environments.
- Labelling, traceability and instructions for use - Marking on device, primary packaging requirements, batch/lot identification and required user information (including power injection limits if applicable).
- Test methods and annexes - Normative and informative annexes describe methods for leakage testing, flushing volume determination, needle penetration/withdrawal characterization, multiple puncture testing and peak tensile force.
Practical applications and users
EN ISO 10555-6 is essential for:
- Medical device manufacturers designing and producing subcutaneous ports and catheters - to meet harmonized performance and safety expectations.
- Quality, regulatory and compliance teams preparing technical files and demonstrating conformity with EU medical device directives and national standards.
- Test laboratories performing bench testing (leakage, burst pressure, tensile force, MRI assessment).
- Procurement and clinical engineering evaluating product specifications for long‑term vascular access and power injection suitability.
- Clinicians who need clarity on device limitations (e.g., power injection rating, flushing volume) and safe use information.
Related standards
Use EN ISO 10555-6:2017 for product development, regulatory compliance and to ensure safe, standardized performance of implanted vascular ports and their catheters.
