ISO 7199 Cardiovascular Implants and Artificial Organs - Test Standard for Blood Gas Exchangers

ISO 7199 specifies requirements for sterile, disposable, extracorporeal blood gas exchangers (oxygenators) intended for the supply of oxygen to and removal of carbon dioxide from human blood.

ISO 7199 also applies to heat exchangers and arterial filters, which are integral parts of the oxygenator.
ISO 7199 also applies to external equipment specific to the use of the oxygenator.

ISO 7199 does not apply to;

• implanted oxygenators,
• liquid oxygenators,
• Extracorporeal circuits (blood tube),
• separate heat exchangers,
• separate assistive devices,
• Separate arterial line filter.

Tests and measurements should be performed with the device under test prepared according to the manufacturer's instructions for the intended clinical use. Study variables will be those specified by the manufacturer for the intended clinical use, unless otherwise stated.

Unless otherwise stated, the temperature of the test liquids will be (37 ± 1) °C.

If the relationship between variables is non-linear, sufficient determinations will be made to allow valid interpolation between data points. Test or measurement procedures should be considered as reference procedures. Other procedures may be accepted, provided that the alternative procedure can be shown to have comparable precision and reproducibility.

EUROLAB assists manufacturers with ISO 7199 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.