SIST EN ISO 7199:2024 PDF

Overview

EN ISO 7199:2024 (Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)) is the CEN-adopted, fourth-edition international standard specifying safety, performance and labelling requirements for sterile, single‑use extracorporeal blood‑gas exchangers (oxygenators). It applies to devices used to oxygenate and remove carbon dioxide from human blood during cardiopulmonary bypass (CPB) for up to 6 hours, extracorporeal lung assist (ECLA - VV, VA, VAV strategies), cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques requiring blood‑gas exchange. The document also covers integral heat exchangers and arterial filters and external equipment unique to oxygenator use. It does not apply to implanted or liquid oxygenators, separate heat exchangers, tubing circuits or standalone ancillary devices.

Key Topics and Requirements

EN ISO 7199:2024 defines clear technical and testing expectations, including:

• Biological characteristics: sterility, non‑pyrogenicity and biocompatibility requirements and associated testing.
• Physical characteristics: integrity of blood and heat exchanger pathways, priming and blood volumes, and connector specifications.
• Performance characteristics: oxygen and carbon dioxide transfer rates, heat‑exchanger performance factor, integral arterial filtration efficiency, flow capacity, air‑handling, and limits on blood cell damage (haemolysis, platelet and white‑cell reduction).
• Time-dependent performance and shelf life: required evaluations for changes during intended use and storage.
• Tests and measurements: standardized methods for verifying compliance (biological, physical and performance tests).
• Information and packaging: manufacturer labelling, user information, unit and shipping container requirements and documentation supplied with the device.

Notable editorial changes from earlier editions include corrected definitions (e.g., platelet reduction, plasma free haemoglobin), addition of priming volume definition and other clarity updates.

Applications

EN ISO 7199:2024 is used to:

• Guide design and development of single‑use oxygenators and integrated components.
• Define manufacturing and quality control test protocols and acceptance criteria.
• Support regulatory submissions and conformity assessment in Europe and internationally.
• Inform clinical procurement, device selection and hospital policies for extracorporeal support systems.
• Provide test lab methods for performance validation (oxygenation, CO2 removal, filtration, haemocompatibility).

Who uses this standard

• Medical device manufacturers and design engineers
• Regulatory and quality assurance teams
• Test laboratories and certification bodies
• Hospital biomedical engineering and clinical perfusionists
• Procurement and risk‑management professionals

Related guidance

The standard contains normative references and test methods; users should consult the full EN ISO 7199:2024 document for detailed test procedures, referenced standards, and labelling requirements before product development, testing or regulatory submission.