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.

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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.
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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

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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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