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Valid from 05.07.2026

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This ISO 7199 2024 vs 2017 comparison helps manufacturers and regulatory teams quickly identify what has changed in the requirements for extracorporeal blood-gas exchangers. Our gap analysis breaks down clause-by-clause revisions, so your team can update device documentation and validation processes without re-reading the entire standard. This standard specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supplying oxygen to, and removing carbon dioxide from, human blood during cardiopulmonary bypass (CPB) for up to 6 hours, extracorporeal lung assist (ECLA with veno-venous, veno-arterial, or veno-arterial-venous cannulation strategies), cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques requiring blood-gas exchange. It also applies to heat exchangers and arterial filters that are integral parts of the oxygenator. The standard does not apply to: Implanted oxygenators Liquid oxygenators Extracorporeal circuits (blood tubing) Separate heat exchangers Separate ancillary devices Separate arterial line filters Whether you're updating a Design History File, preparing regulatory submissions, or responding to a notified body query, this ISO 7199 2024 vs 2017 report gives you a clear, audit-ready summary of exactly what's changed between the two revisions.