Overview
EN ISO 10555-1:2023 - published by CEN and identical to ISO 10555-1:2023 - defines the general requirements for sterile, single‑use intravascular catheters. This third edition supersedes the 2013 version and applies to intravascular catheters supplied sterile and intended for single use for any application. It does not cover catheter accessories (for example, those under ISO 11070).
Key topics and technical requirements
The standard sets out high‑level design, safety and testing expectations for intravascular catheters, including:
- Risk approach and usability engineering - requirements to identify hazards and address user‑interface risks during design.
- Sterilization and shelf life - requirements for devices supplied sterile and information on stability over time.
- Biocompatibility and surface integrity - expectations for materials in contact with blood/tissue and coatings.
- Mechanical performance - tests and requirements for peak tensile force, kink/torque resistance, hubs, and distal tip stiffness (notably for neurovascular applications).
- Leakage and pressure performance - procedures for leakage during pressurization and aspiration, burst pressure, and power injection burst pressure where applicable.
- Fluid performance - determination of catheter flowrate and power injection flow/pressure testing.
- Corrosion resistance and particulate/coating integrity - test methods and considerations for device longevity and safety.
- Packaging and labelling - requirements for sterile packaging systems, device marking, instructions for use, and information to be supplied with the catheter.
- Test methods - several normative annexes provide test procedures (e.g., tensile, leakage, burst pressure, flowrate, power injection and corrosion tests) and informative annexes supply rationale and guidance.
Applications and who uses this standard
EN ISO 10555-1:2023 is intended for professionals involved in the lifecycle of intravascular catheters:
- Medical device manufacturers - to design, test and document compliance for sterile single‑use catheters.
- Quality and regulatory teams - for conformity assessment, technical files and CE/national approvals.
- Testing laboratories and notified bodies - to perform standardized mechanical, leakage and biocompatibility tests.
- Procurement and clinical engineering - to specify performance, packaging and labelling requirements.
- Clinicians and hospital safety officers - to understand device labelling, intended use and compatibility with clinical procedures (e.g., power injection cases).
Related standards
- ISO 10555 series (other parts covering specific catheter types and requirements)
- ISO 11070 (covers some catheter accessories)
- Relevant sterilization, biocompatibility and risk management standards referenced within the document
EN ISO 10555-1:2023 is a foundational standard for ensuring safety, performance and regulatory readiness of sterile single‑use intravascular catheters.
