Biocompatibility testing of medical devices are a critical part of ensuring product safety and regulatory compliance of products in contact with the human body. Measurlabs offers the full range of biocompatibility tests according to ISO 10993 and our team of experts is happy to help with questions regarding testing specifications.
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What is biocompatibility testing?
Medical devices and materials that are intended to be used in contact with a patient's body need to be tested to ensure that they do not cause any acute or chronic adverse effects. Testing the biocompatibility of the product is thus an important part of the product development and market release of medical devices.
Each medical device or related material must be individually evaluated taking into consideration the intended use. Different use cases require different tests, which means that the testing plan must always be tailored for each product separately. For example, for products that are intended to be used on intact skin, the required level of biological safety studies is lower compared to implantable medical devices that are in contact with bone, tissue, or blood, and are created for long-term or permanent use.
What are the different biocompatibility tests?
The most basic evaluation is based on studying the medical device's effect on cell viability (cytotoxicity), followed by skin irritation and sensitization, which evaluate the device's tendency to cause a reaction with the patient's tissue. If the device is in contact with blood, the interaction between blood and the device (hemocompatibility) is an important analysis to include. Other tests that can be necessary depending on the nature of the device are the presence of toxins that can impact the genetic material of the cells it is in contact with (genotoxicity), characterization of chemicals that might migrate from the device to the tissue surrounding it, and determining the number of micro-organisms on the device (bioburden).
Biocompatibility testing standards
The ISO 10993 standard is the most commonly used guideline for assessing biocompatibility. Part 1 of the standard determines the correct steps to be taken for the biocompatibility evaluation, and the following parts describe protocols for the evaluation of the individual properties. The standard also includes a table that helps in determining the necessary tests for devices with different use purposes.
Need a biocompatibility analysis?
Measurlabs offers high quality biocompatibility testing for medical devices according to ISO 10993. Our experts are happy to help with your questions related to the tests and your samples. Fill in the form below or email us your testing needs and sample specifications to firstname.lastname@example.org, and we will send you a quote for the analyses.
Suitable sample matrices
- All types of medical devices for external and internal use
- Skin irritation & sensitization tests
- Bioburden (sterilization residuals)
- Genotoxicity, carcinogenicity& reproductive toxicity
Frequently asked questions
Measurlabs offers a variety of laboratory analyses for product developers and quality managers. We perform some of the analyses in our own lab, but mostly we outsource them to carefully selected partner laboratories. This way we can send each sample to the lab that is best suited for the purpose, and offer high-quality analyses with more than a thousand different methods to our clients.
When you contact us through our contact form or by email, one of our specialists will take ownership of your case and answer your query. You get an offer with all the necessary details about the analysis, and can send your samples to the indicated address. We will then take care of sending your samples to the correct laboratories and write a clear report on the results for you.
Samples are usually delivered to our laboratory via courier. Contact us for further details before sending samples.