A thorough assessment of biocompatibility is needed to ensure that medical devices are safe for patients and compliant with regulatory requirements. Measurlabs offers an extensive range of biocompatibility tests according to the ISO 10993 standard family, helping manufacturers comply with the EU Medical Device Regulation and FDA 510(k) premarket submission requirements. Our team of experts is also happy to help with questions regarding testing specifications - you can book a free 30-minute kick-off consultation here to discuss the tests required for your device.
What is biocompatibility?
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 planning the biocompatibility evaluation, and the following parts describe the protocols for assessing 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 ISO 10993-1 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, so the testing plan and parameters must always be tailored for each product separately.
More rigorous testing is needed when devices come into contact with blood or tissues other than intact skin for a prolonged period. Correspondingly, devices that are only meant to touch intact skin for a limited time require fewer tests.
All medical devices intended to come into contact with the human body should undergo the following biocompatibility testing:
Characterization of chemicals that might migrate from the device to the tissue surrounding it
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 tissues
Additional tests that may be required depending on the device's intended use include:
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
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 tests, which may be sufficient for medical R&D projects and regulatory compliance of low-risk devices in some jurisdictions. 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 and other widely recognized standards, such as ISO 11737 for assessing bioburden and ISO 18562 for evaluating devices with breathing gas pathways.
Our experts are also happy to help with any questions about 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.