EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 15674 testing. ISO 15674 specifies requirements for sterile, disposable, extracorporeal hard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as blood storage during cardiopulmonary bypass (CPB) surgery.
ISO 15674 is a standard in the field of cardiovascular implants and artificial organs. Specifically, it relates to both filtered and unfiltered hard-shell cardiotomy/venous reservoir systems as well as soft venous reservoir bags. These systems are important components in cardiovascular surgery and extracorporeal circulation procedures.
Hard Shell Cardiotomy/Venous Reservoir Systems: These systems are used in cardiac surgery and other procedures involving extracorporeal circulation (circulation of blood outside the body). They are designed to collect and temporarily hold blood, allowing the surgical team to remove air, debris, and other unwanted components from the blood before the blood is reintroduced into the patient's circulatory system. The hard shell design provides structural support and protection to the reservoir, keeping the blood free of contaminants during the procedure.
Filters (Optional): Some cardiotomy/venous reservoir systems are equipped with filters. These filters are designed to capture any particles or debris present in the blood and prevent them from re-entering the patient's bloodstream. Filters play a crucial role in maintaining blood quality and reducing the risk of complications during procedures.
Soft Venous Reservoir Bags: In addition to hard-shell reservoirs, there are soft venous reservoir bags. These bags are more flexible and can be useful in procedures where space is limited or where the flexibility of the reservoir is advantageous. Soft venous reservoir bags also serve the purpose of collecting and holding blood during procedures.
ISO 15674 standardizes the requirements and specifications for these cardiovascular implant components, ensuring their safety, performance, and compatibility with medical devices and surgical procedures. The standard addresses factors such as design, materials, labeling, biocompatibility, sterility and performance testing.
By adhering to ISO 15674, manufacturers and medical professionals can help ensure that the cardiovascular implant components they use meet international standards for quality and safety. This, in turn, contributes to better patient outcomes and reduces the risks associated with procedures involving cardiovascular surgeries and extracorporeal circulation.
EUROLAB assists manufacturers with ISO 15674 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.
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