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Glossary Term
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ISO 7199 ( Cardiovascular Implants and Artificial Organs – Blood-Gas Exchangers)

Definition

ISO 7199 is an international standard that establishes the design, testing, and performance requirements for blood-gas exchangers, commonly known as oxygenators. These devices facilitate gas exchange during extracorporeal procedures, such as cardiopulmonary bypass or extracorporeal membrane oxygenation (ECMO). The standard ensures safety, biocompatibility, and effective operation during critical medical procedures.

Relevance to the MedTech Industry

ISO 7199 ensures that blood-gas exchangers meet rigorous safety and performance standards, minimizing risks to patients during life-supporting procedures. It provides a framework for manufacturers to validate device design, materials, and functionality to support regulatory compliance and patient safety.

Additional Information & Related Terms

Key Components of ISO 7199

  1. Performance Requirements

    • Specifies parameters for oxygen transfer efficiency, carbon dioxide removal, and durability under physiological conditions.

  2. Biocompatibility and Hemocompatibility

    • Ensures materials are compatible with blood and do not cause adverse reactions, such as clotting or hemolysis.

  3. Mechanical Integrity

    • Requires testing to confirm that the device can withstand operational pressures and handling without failure.

  4. Sterilization and Packaging

    • Mandates that devices maintain sterility and integrity during storage, transport, and use.

  5. Labeling and Instructions

    • Ensures that devices are accompanied by clear labeling, including specifications for use and limitations.


Examples of Applications

  • Cardiopulmonary Bypass (CPB): Blood-gas exchangers used during heart surgeries to oxygenate blood and remove carbon dioxide.

  • ECMO: Long-term oxygenation support for patients with severe respiratory or cardiac failure.

  • Artificial Lungs: Devices integrated into extracorporeal life support systems for gas exchange.

Related Terms

  • Biocompatibility Testing (ISO 10993): Ensures materials used in blood-gas exchangers are safe for contact with blood.

  • Hemolysis Testing: A key evaluation to ensure blood-gas exchangers do not cause red blood cell damage.

  • ISO 13485: Medical device quality management systems, which often incorporate compliance with ISO 7199.

  • Sterilization Validation (ISO 11137): Ensures blood-gas exchangers are properly sterilized and maintain sterility during use.

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