sterility assurance testing for medical devices

Sterility Assurance Testing for Medical Devices

Ensuring safety and efficacy of medical devices with Sterility Assurance Testing solutions

Ensuring safety and efficacy of medical devices with Sterility Assurance Testing solutions


Routine sterility assurance testing, otherwise known as lot release testing, is a critical component of the manufacturing process for medical devices. This type of testing is used to ensure that products are free from harmful microorganisms, which could pose a significant risk to patient safety. Manufacturers perform routine sterility assurance testing to identify any potential contamination during the manufacturing process and confirm the effectiveness of their sterilization methods.

This testing is an essential step to ensure that medical devices are safe for patient use. Routine sterility assurance testing is also a regulatory requirement for medical device manufacturers, as it is mandated by organizations such as the U.S. Food and Drug Administration (FDA) and other regulatory agencies. Compliance with these regulations is of utmost importance to ensure that products meet the required safety standards and can be legally marketed and sold.


There are a variety of tests that can be performed to ensure that manufacturers have control over their manufacturing processes, like product bioburden, bacterial endotoxin, product sterility, and more. These tests can vary depending on the type of device being manufactured and the intended use of the device. Some of the common tests that are included in sterility assurance testing include:

  • Bioburden testing: This involves assessing the number of microorganisms present on the device before sterilization.
  • Sterilization validation: This verifies that the sterilization process is effective in killing or removing all viable microorganisms from the device.
  • Endotoxin testing: This tests for the presence of endotoxins, which are bacterial toxins that can cause adverse reactions in the body.
  • Microbial identification testing: This involves identifying any microorganisms that are present on the device to determine if they are harmful.
  • Particulate testing: This assesses the level of particulate matter on the device to ensure it is within acceptable limits.
  • Environmental monitoring: This involves monitoring the manufacturing environment to ensure that it is free from contaminants that could impact the sterility of the device.
  • Cytotoxicity testing: Ensures the devices are not toxic or harmful to the human body.

In addition to these tests, the sterility assurance testing procedures must also include documentation and record-keeping requirements. Medical device manufacturers must maintain a complete record of sterility assurance testing procedures, including the test results, and make them available for review by regulatory authorities.



  1. Ensuring safety: By performing tests to detect contamination, biocompatibility, sterility, and other potential issues, manufacturers can identify and correct any problems before they release the devices to the market.
  2. Quality assurance: By testing samples from each production lot, manufacturers can ensure that their devices meet the required specifications and function as intended.
  3. Regulatory compliance: Sterility assurance testing is a regulatory requirement in many countries, including the EU and the United States. By performing these tests and maintaining records of the results, manufacturers can demonstrate compliance with regulatory requirements and avoid potential legal and financial penalties.
  4. Improved customer confidence: When medical devices undergo rigorous sterility assurance testing, it can increase customer confidence in the product. Patients and healthcare providers can be assured that the devices have been thoroughly tested and meet the necessary standards for safety and quality.
  5. Continuous improvement: Sterility assurance testing can also help manufacturers identify areas for improvement in their production processes. By analyzing the results of the tests, manufacturers can identify trends and make changes to their processes to improve the quality and consistency of their devices.
  6. Maintain control over the manufacturing process.



TÜV SÜD is a trusted provider of sterility assurance testing services for medical devices, offering a comprehensive range of solutions required by relevant regulatory frameworks worldwide. With state-of-the-art laboratories, our complete sterility assurance testing panel ensures high standards of data and quality reporting to meet the testing needs of manufacturers of all sizes. 

Our team of medical doctors, engineers, and toxicologists possess the technical, clinical, and regulatory expertise required to thoroughly evaluate sterility assurance test results of medical devices for suitability across global markets. We provide end-to-end assistance with efficient use of resources while ensuring project timelines are met with predictability and diligence so that you can have confidence in the safety and efficacy of your products.

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TÜV SÜD provides the following sterility assurance tests to help manufacturers meet the requirements of the International Organization for Standardization (ISO), U.S. Food and Drug Administration (FDA) and American Society for Testing and Materials (ASTM). 

Sterility Testing

  • ANSI 11137 
  • AAMI 11137
  • ISO 11137 
  • ISO 13004

Bioburden Testing

  • ANSI 11737
  • AAMI 11737
  • ISO 11737
  • ISO 11135
  • EN 1174



TÜV SÜD is globally recognized for its quality and safety as a third-party one-stop testing provider. Besides sterility assurance testing, we also offer a suite of other testing services required for medical devices, such as biological evaluation plan, biocompatibility testing for medical devices and reusable device testing. Through this, we help manufacturers and suppliers independently meet global regulatory standards. Our global network of medical health and services professionals is recognized as authorities in their fields. Their collective expertise makes TÜV SÜD a trusted partner of choice for manufacturers seeking accreditations in line with medical device regulations.

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