Endotoxin Test


Endotoxin Test

USP<85>& USP<161> & ANSI/AAMI ST72 & ISO 10993-11

WISE Company has been providing endotoxin testing services based on over 10 years of experience and understanding of CE and FDA requirements.

Test Required time
Endotoxin test in accordance with EU or US requirement 1 week

 

What is an endotoxin test?

An endotoxin test is a procedure to verify whether the amount of endotoxins, which can cause fever in the human body, meets specified standards.

Endotoxins are heat-resistant lipopolysaccharides (LPS) found in the cell walls of gram-negative bacteria. Even in trace amounts, they can induce fever and inflammatory responses. These endotoxins are released when bacteria are killed during sterilization of medical devices.
 

Why is an endotoxin test conducted?

Medical devices that come into direct or indirect contact with the human body must ensure, through endotoxin testing, that the levels of pyrogenic substances in the product are below the acceptable threshold. Regulatory agencies in the U.S. and Europe require verification for every lot or the establishment of a reasonable and effective validation plan.
 

Which medical devices require endotoxin testing?

Medical devices requiring endotoxin testing include:

  • – All medical devices labeled as non-pyrogenic.
  • – Medical devices in direct or indirect contact with the human body, particularly devices in contact with cardiovascular, lymphatic, or cerebrospinal fluids.
  • – Implanted or injectable medical devices.

 

How is an endotoxin test performed?

Endotoxin testing is conducted as follows:

  • 1. The test is performed using a colorimetric method in compliance with relevant USP and ANSI standards.
    • – Colorimetric method: A testing method that uses color changes as an indicator through the hydrolysis of synthetic substrates.
  • 2. The number of test samples is determined based on lot size, in accordance with ANSI standards.
  • 3. The test results include the following:
    • A. Verification of calibration curve reliability.
    • B. Negative control results.
    • C. Quantitative testing and confirmation of interference factors.
    • D. Summary of test results.

 

Please CONTACT US for any endotoxin test related inquiry.