Overview
ISO 10555-1:2023 - "Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements" - specifies the general requirements and test methods for intravascular catheters supplied sterile and intended for single use. This third edition updates and replaces ISO 10555-1:2013 and incorporates changes covering risk management, usability engineering, sterilization, shelf life, packaging, and new or revised test methods. The standard applies to catheters for any intravascular application but does not apply to catheter accessories (for example, those covered by ISO 11070).
Key topics and technical requirements
- Risk approach & usability: Requires conformity with risk management (ISO 14971) and application of usability engineering (IEC 62366-1).
- Sterilization & shelf life: Specifies requirements for sterile supply and stability/shelf-life evidence consistent with ISO 11607-1.
- Biocompatibility & surface/coating: Addresses biocompatibility (ISO 10993-1), coating integrity, particulate testing and hydratable catheter behavior (post-hydration conditions defined).
- Mechanical and leakage performance:
- Peak tensile force and gauge-length testing (Annex B).
- Leakage under pressurization and aspiration (Annex C, D, I).
- Corrosion resistance (Annex A).
- Burst pressure and power-injection testing where applicable (Annex F, G).
- Flowrate determination (Annex E).
- Designation & dimensions: Defines nominal outside/inside diameters and effective length; provides guidance for hydratable devices and nominal inside diameter for certain applications.
- Packaging & labelling: Primary/secondary packaging, device marking and Instructions for Use (IFU) requirements including power-injection test details.
- Special tests: Simulated use (kink/torque), distal tip stiffness for neurovascular applications (Annex K), and optional particulate/coating tests depending on risk analysis.
Practical applications - who uses this standard
- Device manufacturers: for product design input, verification & validation testing, labelling, and IFU content.
- Test laboratories: to implement the normative test methods in the annexes.
- Regulatory and quality teams: to demonstrate conformity with international medical device requirements.
- Procurement and clinical engineers: to evaluate product claims (e.g., power injection compatibility, sterilization, shelf life).
- Clinical researchers: to understand device performance limits and intended use statements.
Related standards
Keywords: ISO 10555-1:2023, intravascular catheters, sterile single-use catheters, medical device standards, risk management, sterilization, flowrate, burst pressure, leakage testing.
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