ISO 18250-8 Medical Devices - Connectors for Reservoir Distribution Systems for Healthcare Applications - Part 8: Citrate-Based Anti-Coagulation Solution for Apheresis Applications

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 18250-8 testing. This standard specifies dimensions and requirements for the design and functional performance of apheresis anticoagulant (AC) reservoir connectors.

This standard does not specify dimensions and requirements for medical devices or accessories that use these connectors. Such requirements are specifically given in International Standards for certain medical devices or accessories.

The following medical device examples are intended to use connectors of this standard:

• Apheresis tubing sets and mating reservoirs containing citrate-based anticoagulant solution;
• Apheresis tube sets may include, but are not limited to, those for use in blood collection, therapeutic applications, and plasma collection.

Some apheresis sets are manufactured with a pre-connected reservoir containing a citrate-based anticoagulant solution. These medical devices are not designed to use connectors of this standard.

Manufacturers are recommended to include the connectors specified in this standard in their apheresis devices or accessories, even if they are not currently required by certain medical device standards. Requirements for apheresis AC reservoir connectors are expected to be included when certain medical device standards are revised.

EUROLAB assists manufacturers with ISO 18250-8 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.