Overview
ISO 18242:2016 - Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps - specifies requirements and test methods for sterile, single‑use extracorporeal centrifugal blood pumps (coated, surface‑modified or not) intended to produce blood flow during extracorporeal circulation. The standard covers devices used for cardiopulmonary bypass, veno‑venous bypass, kinetic‑assisted venous drainage, and extracorporeal membrane oxygenation (ECMO). It does not apply to centrifugal pumps used as ventricular assist devices (VADs) or to other extracorporeal components such as tubing or pump consoles.
Key topics and technical requirements
- Scope & definitions: Clear terms for centrifugal blood pump, blood pathway, operating variables, blood cell damage, normalized index of hemolysis (NIH), etc.
- Biological requirements:
- Sterility and non‑pyrogenicity verification per sterilization and biocompatibility standards.
- Biocompatibility of all blood‑contacting parts (refer to ISO 10993 series).
- Physical integrity:
- Blood pathway leak test: 1.5× manufacturer’s max pressure or 152 kPa if unspecified; visual inspection for minimum 6 hours.
- Prime volume: measured from inlet tip to outlet tip across operating range.
- Connector integrity: must withstand a 15 N pull for 15 s; common connector inner diameters noted (4.8, 6.3, 9.5, 12.7 mm) and ISO 7199 compatibility.
- Performance testing:
- Hydraulic performance: measure flow vs pressure differential across RPM range; test at 37 °C ± 1 °C using blood analogue or anticoagulated blood.
- Blood cell damage: in‑vitro tests with anticoagulated whole blood measuring plasma‑free hemoglobin, platelet and white blood cell counts at defined time points (pre, 30, 180, 360 min); NIH and hemolysis reporting expected.
- Bearing durability: worst‑case conditions at max RPM and clinical backpressure; operate for minimum of 6 hours (or manufacturer‑specified).
- Shelf life: accelerated aging of finished, packaged devices to demonstrate rated shelf life.
- Manufacturer information: required labeling and performance parameters to enable device comparison.
Applications and users
ISO 18242:2016 is used by:
- Medical device manufacturers to design, verify and document centrifugal pump safety and performance.
- Test laboratories to perform standardized hydraulic, hemolysis and durability testing.
- Regulatory authorities and notified bodies for evaluation of extracorporeal single‑use pumps.
- Clinical engineers and procurement teams who compare pump performance and labeling for purchase or clinical selection.
Related standards
Normative references commonly used with ISO 18242 include:
Keywords: ISO 18242:2016, centrifugal blood pumps, extracorporeal, cardiopulmonary bypass, ECMO, biocompatibility, hydraulic performance, hemolysis, NIH, medical device testing.
