Biocompatibility testing of medical devices

Published October 4, 2022

Oona Korhonen

Oona Korhonen – PhD, bioproduct technology

LinkedIn

Biomass & medical devices, Measurlabs

oona.korhonen@measurlabs.com

Biocompatibility testing is a critical step in the development of medical devices. A thorough assessment of biocompatibility helps manufacturers ensure that their devices will be safe for patients and provides data that can be used to support regulatory compliance. 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.

ISO 10993 standard provides the guidelines for testing medical devices

Part 1 of the ISO 10993 standard describes the correct steps for biocompatibility evaluation, and the following parts describe the protocols for assessing the individual properties. The standard also includes a table that helps to 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 meant to be in contact with the human body should undergo the following biocompatibility testing: 

  • Cytotoxicity, which measures the device's effect on cell viability

  • Sensitization and irritation, which estimate the device's tendency to cause a reaction with the patient's tissue

  • Characterization of chemicals that might migrate from the device to the tissue surrounding it

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

  • 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 determines the number of micro-organisms on the device

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 is often started with in vitro testing, which may be sufficient for some medical R&D projects. Official certification for medical devices does, however, usually require in vivo biocompatibility tests to be performed. 

Need a biocompatibility analysis?

Measurlabs offers high-quality biocompatibility testing for medical devices according to the ISO 10993 standard. 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 at info@measurlabs.com, and we will get back to you within one business day.

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