Overview
ISO 18193:2021 - Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation - defines requirements and test procedures for sterile, single‑use cannulae used to remove and return blood in extracorporeal circulation (ECC). The standard covers clinical scenarios such as cardiopulmonary bypass (CPB up to 6 h), extracorporeal lung assist (ECLA, VV/VAV/AV), left/right heart bypass (LHB/RHB), cardiopulmonary support (CPS), extracorporeal life support (ECLS, VA), and extracorporeal carbon dioxide removal (ECCO2R). It is focused on ensuring cannulae safety, performance characterization, and consistent labelling - not on introducers, isolated organ perfusion cannulae, or intravascular catheters.
Key Topics and Technical Requirements
The standard organizes requirements into clear technical areas:
- Biological characteristics
- Sterility and non‑pyrogenicity
- Biocompatibility per ISO 10993 series
- Physical characteristics
- Blood pathway integrity and material compatibility
- Connectors and interchangeability
- Kink resistance and collapse resistance
- Pull strength, external surface finish, corrosion/abrasion resistance
- Radio‑detectability and meaningful distance/lumen markings
- Performance characteristics
- Pressure drop and hydraulic performance
- Recirculation behavior (especially important for dual‑lumen designs)
- Blood cell damage assessment (hemolysis)
- Shelf life and packaging integrity
- Conformity testing & reporting
- Type test procedures for performance and blood trauma (test setups described in annexes)
- Manufacturer information and labelling requirements to allow objective comparison
Note: ISO 18193 defines test methods and reporting formats but does not set numeric pass/fail limits for many performance attributes; it is intended to standardize evaluation and disclosure.
Practical Applications - Who Uses ISO 18193
- Medical device manufacturers designing and validating extracorporeal cannulae
- Regulatory and quality teams preparing technical files and type‑testing evidence
- Test laboratories conducting kink, pressure drop, radio‑opacity, and hemolysis tests
- Hospital procurement, perfusionists, and clinical engineers comparing cannula performance for CPB, ECLS, ECLA, or ECCO2R procedures
- Standards committees and product development teams aligning device labelling and user information
Related Standards
ISO 18193 references and aligns with several standards for sterilization, biocompatibility, packaging and connectors, including:
ISO 18193:2021 is essential for ensuring safe, consistent performance and transparent labelling of cannulae used in extracorporeal circulation.
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