Overview
ISO/TS 23810:2018 - Cardiovascular implants and artificial organs - Checklists for use of extracorporeal circulation equipment - is a Technical Specification that defines checklists for activities performed by perfusionists before, during and after extracorporeal circulation (ECC). It covers preoperative setup for cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), cardiopulmonary support (CPS), left/right heart bypass (LHB/RHB) and venovenous (VV) extracorporeal support used in procedures such as liver transplantation.
The document is checklist-focused: Clause 4 addresses preoperative ECC equipment setup, and additional checklists address termination (Clause 5), post-ECC (Clause 6), emergent reinstitution of ECC (Clause 7) and peri-procedural activities (Clause 8). The sequence of items can be adapted to institutional practice.
Key Topics
ISO/TS 23810:2018 organizes practical verification points across ECC systems, including:
- Patient information: identity, allergies, blood type/antibodies, medical record and procedure verification.
- Equipment and Instructions for Use (IFU): presence, compatibility and IFU availability.
- Sterility and component integrity: package integrity, expiration, serial/lot traceability.
- Pumps: electrical supply, batteries, roller and centrifugal pump checks.
- Cardioplegia: solutions, delivery methods, temperature control and leak/bubble prevention.
- Medical gas and vacuum supply: gas sources, blenders, hoses, connectors, pressures and exhaust.
- Components and tubing: connections, tubing direction/length, one‑way valves, leak and patency checks.
- Safety mechanisms: alarms, arterial filters/bubble traps, reservoirs, line occluders, vents and level sensors.
- Assisted venous return: positive/negative pressure relief, vacuum regulators and kinetic assistance.
- Monitoring and anticoagulation: temperature probes, pressure transducers, flow sensors and anticoagulation monitoring.
- Temperature control and supplies: water supplies, ranges and related consumables.
These topics form a pragmatic checklist to verify that devices, systems and consumables are set up correctly and safely.
Applications
ISO/TS 23810:2018 is intended for practical use by:
- Perfusionists and ECMO specialists performing ECC setup and management.
- Operating room teams and cardiac surgery staff to support consistent pre-op checks.
- Clinical engineers and biomedical staff responsible for equipment commissioning and maintenance.
- Hospital quality, safety and risk management teams for auditing, incident prevention and protocol standardization.
- Educators and trainers designing simulation and competency assessments.
Typical applications include preoperative verification, intraoperative safety checks, emergent reinstitution protocols, post-procedure handover, training curricula and institutional checklist implementation to reduce equipment-related errors.
Related standards
Refer to the broader ISO cardiovascular implants and artificial organs series and local clinical guidelines for complementary requirements on device performance, hospital medical gas systems and clinical governance. Use ISO/TS 23810:2018 as a practical checklist resource to align ECC setup with institutional policies and international best practice.