ISO 10555-1:2023 is an international standard for sterile, single-use intravascular catheters. It sets general requirements used in design verification and quality control for catheters intended for any intravascular application.
If you need help mapping the requirements to your catheter type (and to the right bench setups for your lab), talk with our team about your device and the edition you need to cite.
ISO 10555-1:2023 — Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
ISO 10555-1 is a requirements-focused document supported by referenced and embedded test methods commonly used to demonstrate that an intravascular catheter design meets functional and mechanical expectations for clinical use.
It applies to intravascular catheters supplied sterile and intended for single use, and it does not apply to intravascular catheter accessories (which may be addressed by other standards such as ISO 11070).
Quick Definition
Standard type: International Standard (general requirements with associated verification testing)
What it covers: Baseline performance, safety, and verification needs for sterile, single-use intravascular catheters for any intravascular application.
What it does not cover: Intravascular catheter accessories (e.g., accessories addressed by ISO 11070).
What This Standard Covers
ISO 10555-1 establishes general requirements that manufacturers and test labs commonly use when qualifying catheter designs and monitoring production consistency. Depending on catheter design and intended use, the standard is typically associated with verification of mechanical integrity, leakage resistance, and functional performance.
Because the standard is written to apply broadly “for any application,” the exact verification plan is commonly selected using the device design, intended use, and a risk-based approach rather than a one-size-fits-all test list.
Why This Standard Matters in Testing
Intravascular catheter failures can create immediate patient risk. ISO 10555-1 is frequently used to drive objective, repeatable bench checks that support design validation, supplier qualification, incoming inspection strategies, and ongoing process monitoring.
For lab managers and QA/QC teams, the practical value is that ISO 10555-1 helps define what needs to be demonstrated (and documented) around catheter integrity and performance, which directly influences fixture design, pressure/flow capability, and data reporting requirements.
Common Materials, Product Types, or Applications Covered
ISO 10555-1 is used across a wide range of sterile, single-use catheter products intended to be inserted into the vascular system.
Common product examples: Peripheral intravascular catheters, central venous catheter systems, angiographic and interventional catheter designs, and other intravascular catheters where mechanical integrity and leakage performance must be demonstrated.
Common construction features: Single- or multi-lumen tubing, hubs/connectors, junctions/bonds, and designs intended to be pressurized, aspirated, or used with controlled flow.
Common Test or Verification Workflow
A typical ISO 10555-1 verification plan combines multiple bench evaluations selected to match the catheter design and labeled use. Many programs include a mix of mechanical testing (to confirm strength at tubing and junctions) and functional testing (to confirm leakage resistance and performance under pressure or flow).
Common workflow elements: Define samples and conditioning; run mechanical integrity checks (e.g., peak tensile force of tubing and junctions); run leakage testing under pressurization and/or aspiration; confirm flow-related performance when applicable; document results with the exact cited edition and any justified deviations.
Equipment Commonly Used for This Standard
ISO 10555-1 can drive multiple equipment needs. The best-fit configuration depends on the catheter’s diameter, construction, connectors, and whether the design is intended to see pressure, aspiration, or controlled flow in use.
Common equipment families: Universal testing machines for tensile testing (tubing and junctions); tensile grips and specialty fixtures for medical tubing and catheter hubs; pressure/leak test systems for liquid or gas leakage evaluations; burst/pressure capability for applicable high-pressure use cases (including power-injection-related verification when relevant); flow measurement setups for flowrate verification; kink and/or torque fixtures where simulated-use mechanical handling must be evaluated.
If you are selecting a UTM capacity, grips, and pressure instrumentation for catheter verification, you can request a detailed quote for a configuration matched to your sample geometry and test plan.
How to Read This Designation or Revision
ISO 10555-1:2023: “10555” is the standard series for intravascular catheters; “-1” indicates Part 1 (general requirements); “2023” is the publication year for this edition.
Revision sensitivity: Test selection, acceptance criteria, and reporting expectations can change between editions. ISO 10555-1:2013 is withdrawn and a newer published version is ISO 10555-1:2023, so purchase specifications and lab reports should cite the exact edition being used.
Related Standards, Methods, or Frameworks
ISO 11070: Often referenced for intravascular catheter accessories (ISO 10555-1 does not apply to accessories).
Other parts of ISO 10555: The ISO 10555 series also includes parts focused on specific catheter categories (for example, central venous catheters are addressed in ISO 10555-3).
Get help selecting a test setup for ISO 10555-1
If you want to align your verification plan and equipment list with the way ISO 10555-1 is cited in your technical file or customer specification, contact our team with your catheter type, size range, and the exact edition you need to run.