Biocompatibility testing of medical devices

Published October 4, 2022

Biocompatibility testing is a critical step in the development of medical devices. A thorough assessment of biocompatibility helps manufacturers ensure that their devices are safe for patients and provides data that can be used to support regulatory compliance, for example, with the EU Medical Device Regulation. Measurlabs offers an extensive range of biocompatibility tests according to the ISO 10993 standard family. Our team of experts is also happy to help with questions regarding testing specifications.

What is biocompatibility testing?

Part 1 of the ISO 10993 standard defines "biocompatibility" as the ability of a material or product to perform its intended function in contact with the body without eliciting an adverse reaction or compromising normal tissue functions. Biocompatibility testing ensures that materials used in medical devices are compatible with human tissues and do not cause unwanted side effects when in contact with them.

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ISO 10993 standard provides the guidelines for testing medical devices

Part 1 of the ISO 10993 standard describes the correct steps for planning the biocompatibility evaluation, and the following parts describe the protocols for assessing the individual properties. The standard also includes a table that helps determine the necessary tests for devices meant for different purposes.

Different types of biocompatibility testing

The scope of testing recommended by the ISO 10993 standard depends on the type of medical device, the type of contact (e.g. intact skin vs. blood/tissue), and the duration of contact. Different devices require different tests, which means that the testing plan and the test parameters must always be tailored for each product separately. 

Testing needs to be more rigorous for devices that come into contact with blood or tissue for a prolonged period. Correspondingly, fewer tests are needed for devices that are only meant to touch intact skin for a limited time.

All medical devices intended to come into contact with the human body should undergo the following biocompatibility testing: 

Additional tests that may be required depending on the intended use of the device include the following:

  • Toxicological evaluation of extractable and leachable substances

  • Hemocompatibility, which is used to analyze the interaction between blood and the device

  • Pyrogenicity, which assesses whether the device is likely to induce fever or inflammation

  • Genotoxicity, which detects the presence of toxins that may impact the genetic material of surrounding cells

  • Bioburden, which measures the number of micro-organisms on the device

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How is testing performed?

Biocompatibility tests can be performed in two ways: in vitro testing is conducted in test tubes or Petri dishes using animal cells or tissues, while in vivo testing is performed on live animals. The testing process should commence with in vitro testing, which may be sufficient for some medical R&D projects. Official certification for medical devices does, however, often require in vivo biocompatibility tests to be performed. 

Need a biocompatibility analysis?

Measurlabs offers high-quality biocompatibility testing for medical devices according to ISO 10993 standards. Our experts are also happy to help with any questions related to the tests and the required samples. Contact us with your testing needs and sample specifications using the form below, and we will get back to you within one business day.

Request a quote for biocompatibility testing

We offer a comprehensive range of ISO 10993 testing options.

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Answering the following questions helps us prepare an offer faster:

  • What is the intended use of your medical device? What about the body contact site and contact duration?

  • Have you already determined which tests should be conducted on your device?

  • Do you need the tests for R&D purposes or for submission to officials?

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