USP NF 161 Medical Devices, Bacterial Endotoxin and Pyrogen Tests

Chemical Tests

USP NF 161 Medical Devices, Bacterial Endotoxin and Pyrogen Tests

EUROLAB laboratory provides testing and compliance service within the scope of USP NF 161 standard. The methods and requirements in this section apply to assemblies or devices labeled sterile and non-pyrogenic that come into direct or indirect contact with the cardiovascular system, lymphatic system, or cerebrospinal fluid.

USP NF 161 Medical Devices, Bacterial Endotoxin and Pyrogen Tests

This includes, but is not limited to:

  • Fluid routes of catheters and administration sets, such as solution administration sets, extension sets, transfer sets, blood administration sets, intravenous catheters, implants, extracorporeal oxygenator tubes, dialysis tubes, intramuscular drug delivery catheters, and transfusion and infusion devices;
  • Liquid medical devices such as dialysate;
  • Implantable medical devices, such as heart valves and vascular grafts, and other medical devices claiming non-pyrogenic that may come into contact with blood or cerebrospinal fluid;
  • Gels with a non-pyrogenic claim, including demineralized bone matrices and drug delivery systems.

Compliance of the BET test should be demonstrated for each product or product family. The number of product batches selected for compliance work reflects the level of control of the process and should be justified.

For compatibility testing, medical device extracts or liquid medical devices are considered sample solutions tested and tested as outlined for the technique selected in the Bacterial Endotoxins Test 85 Gel-Coag Technique, Preparation Test, Test for Interfering Factors.

EUROLAB assists manufacturers with USP NF 161 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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