Endotoxin Testing in Medical Devices

Endotoxin testing in medical devices

What are the endotoxin limits for medical devices?

The US Center for Devices and Radiological Health has adopted the USP's Endotoxin Reference Standard and medical device extract limits in EU/ml. USP Chapter 161 "Infusions and Infusion Components and Similar Medical Devices" sets out the limits of medical devices within its scope. The endotoxin limit of a medical device depends on the intended use of the device and the objects with which the device comes into contact (eg blood, cardiovascular system, cerebrospinal fluid, intrathecal route of administration, permanently implanted devices and subcutaneously implanted devices). For medical devices, use the following recommended extraction volume recommendations. For products that directly or indirectly contact the cardiovascular and lymphatic systems, the limit is 0.5EU/ml or 20EU/device. For devices in contact with cerebrospinal fluid, the limit is 0.06 EU/ml or 2.15 EU/device. For devices in direct or indirect contact with the ocular environment, lower endotoxin limits may apply.

Our testing services

We follow the USP 85 bacterial endotoxin test and EP 2.6.14 as a method to detect or quantify endotoxins that may be present in medical devices.
The test consists of two different techniques, the gel clot LAL method and the photometric method. Both techniques require preparatory testing to verify that the sample solution does not inhibit or enhance endotoxin testing.
Our kinetic endotoxin laboratory personnel undergo strict technical and laboratory procedure training to ensure that any test glassware or instruments used are free of endotoxin or pyrogens. The gel clot test can be a limit test or an actual determination for quantification.
We use photometer technology, turbidity method and chromogenic gel clot method to test endotoxin, it can be used for endpoint testing or to determine the speed of turbidity development.

Our solutions

Project name	Endotoxin testing in medical devices
Testing purpose	Medical devices will directly contact human tissues and organs, so endotoxins must be tested before use.
Testing cycle	3-5 days.
Service including	We provide you with raw data and test reports.
Price	Inquiry

Sample requirements.

Exogenous endotoxin	The sampling of endotoxin test should avoid the sample being contaminated by exogenous endotoxin.
Container	If the sampling container used for sampling should be depyrogenated, the sample should be tested as soon as possible.
Time	If it fails to detect in time, it should be stored at 4 ℃ or lower to avoid the growth of bacteria and the increase of endotoxin content.

Endotoxin testing in medical devices

Main Benefits:

Approved for use and validated in the same way as LAL (limulus amebocyte lysate), following pharmacopoeia BET (Bacterial Endotoxin Test) chapters.
Higher precision and rate of valid results combined with time-saving sensitivity and lot-to-lot consistency.
100% endotoxin specificity, no false positives from β-Glucan or interference due to colored or turbid samples.

Creative BioMart provides you with endotoxin service. We have a team of professional and well-equipped scientists dedicated to working with researchers around the world to meet customer requirements and ensure quality of service. If you are interested in our applications, please contact us for more details.

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