Overview
ISO 7199:2024 - "Cardiovascular implants and artificial organs - Blood‑gas exchangers (oxygenators)" specifies requirements for sterile, single‑use extracorporeal oxygenators used for oxygenation and CO2 removal in procedures such as cardiopulmonary bypass (CPB, up to 6 h), extracorporeal lung assist (ECLA: VV, VA, VAV), cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA), and extracorporeal carbon dioxide removal (ECCO2R). The standard also covers oxygenators that incorporate integral heat exchangers and arterial filters, plus external equipment unique to oxygenator use. It excludes implanted or liquid oxygenators, separate heat exchangers, tubing circuits and separate ancillary devices.
Key topics and technical requirements
ISO 7199:2024 defines mandatory topics manufacturers and test labs must address, including:
- Biological characteristics
- Sterility and non‑pyrogenicity
- Biocompatibility per risk management
- Physical characteristics
- Blood pathway and heat exchanger fluid pathway integrity
- Priming and blood volumes, connectors and compatibility
- Performance characteristics
- Oxygen and carbon dioxide transfer rates (gas transfer)
- Heat exchanger performance factor
- Integral arterial filtration efficiency, flow capacity and air‑handling capability
- Blood cell damage (haemolysis, platelet and white cell reduction)
- Time‑dependent performance and shelf life
- Testing and reporting
- Type tests and measurement protocols for gas transfer, heat exchange and blood cell damage
- Minimum reporting requirements so users can compare oxygenator performance
- Labelling, information and packaging
- Manufacturer information, unit and shipping container requirements, and accompanying documentation
Note: ISO 7199 provides evaluation procedures and reporting requirements but does not specify numeric performance limits. It also records editorial updates such as addition of a priming volume definition and corrections to certain blood‑damage definitions.
Practical applications and users
ISO 7199 is used to:
- Guide device manufacturers in design verification, production controls and clinical labeling for oxygenators
- Define test protocols for independent test laboratories and QA/validation teams
- Support regulatory submissions and procurement specifications in hospitals
- Help clinical perfusionists and biomedical engineers compare device performance for specific extracorporeal therapies
Keywords: oxygenators, blood‑gas exchangers, extracorporeal, CPB, ECLS, ECCO2R, heat exchanger, arterial filter, single‑use, sterility, biocompatibility.
Related standards
ISO 7199 references and aligns with other standards relevant to medical device safety and sterilization, including:
Use ISO 7199 when specifying, testing or procuring extracorporeal oxygenators to ensure consistent safety, performance reporting and comparability across devices.