Medical Device Biocompatibility Testing

Medical Device Biocompatibility Testing

Protheragen-ING Lab understands the critical importance of biocompatibility testing for medical devices. Biocompatibility testing is an important part of the regulatory process to ensure the safety and efficacy of medical devices before they are introduced to the market. It involves assessing the compatibility of a medical device with the biological systems (living tissues, cells, and fluids in the human body) it comes into contact with. Our comprehensive biocompatibility testing services are designed to meet regulatory requirements and provide you with accurate and reliable data to support your medical device development process.

Why conduct a medical device biocompatibility study?

Fig.1 Medical Device Biocompatibility Testing.

Biocompatibility refers to testing to determine "the likelihood of an unacceptable adverse biological reaction due to contact of the device's constituent materials with the body". Medical equipment must not, either directly or through the release of their chemical components, have a negative impact on the local or systemic environment. Local effects may include skin irritation or burns, while systemic effects may include diseases such as cancer, reproductive effects, or developmental effects.

Biocompatibility testing is nearly always necessary for medical devices that come into touch with human tissue. These tests are used to verify that the gadget is safe and won't hurt the patient or result in any negative reactions.

Comprehensive biocompatibility testing services

Protheragen-ING Lab offers the following biological risk assessment tests. The results of these tests play a critical role in the regulatory approval process of medical devices, helping to ensure patient safety and device effectiveness.

Our tests are typically performed according to the international standard ISO 10993, which provides guidelines for assessing the biosafety of medical devices.

items Details
Cytotoxicity Testing We assess the general level of cytotoxicity of your medical device through in vitro elution and agarose coverage methods.
Sensitization Testing We evaluate the potential of your medical device to induce allergic reactions in individuals through in vivo and in vitro testing methods.
Irritation and Intradermal Reactivity Testing This test helps evaluate the potential of your device to cause irritation or inflammation upon contact with primary skin, eye, and intradermal tissues.
Systemic Toxicity and Systemic Effects of Pyrogenicity We perform acute to chronic systemic toxicity testing to evaluate the potential systemic toxicity and pyrogenicity of your medical device. These tests evaluate the effect of the material's mediated fever-causing compounds (called pyrogens) on the immune system and its potential to cause fever or other systemic reactions.
Genotoxicity Testing This test helps to determine if your device contains the presence of toxins that may affect the genetic material of cells and thus adversely affect human health. We check:
  • Genetic mutation by bacterial mutagenicity test / bacterial revertant mutation test.
  • Chromosomal aberrations by in vitro chromosomal aberration assay, mouse lymphoma assay, and/or in vivo chromosomal damage.
  • DNA damage by in vitro/in vivo chromosomal aberration assay and in vitro/in vivo erythrocyte micronucleus test.
Implantation Testing We evaluate the effects of medical devices on the surrounding living tissue at the macro and micro levels.
Hematological Compatibility Testing This test evaluates the interaction of your device with blood components including coagulation, platelet activation, and hemolysis through hematology and thrombosis testing.
Toxicology Risk Assessment This test helps identify and quantify extractables and leachables in your device. The assessment quantifies the associated risks based on exposure and safe intake dose.
Sterility Testing We perform sterility testing to confirm the absence of live microorganisms in your device. In addition, bioburden testing determines the level of microbial contamination present on the device.
Chemical Characterization This testing employs analytical techniques to identify and quantify information about a medical device's constituent materials, chemicals, or substances.

Advantages of Protheragen-ING Lab

  • Expertise - We have extensive knowledge of regulatory guidelines and industry best practices, ensuring accurate and reliable testing results.
  • Regulatory Compliance - Our testing protocols are designed to meet the requirements of regulatory authorities, facilitating the approval process for your medical device.
  • Timely and Efficient Service - Our streamlined processes and commitment to efficiency ensure prompt delivery of testing results.
  • Quality Assurance - Our laboratory facilities are equipped with state-of-the-art equipment, and we follow strict quality control procedures throughout the testing process.

Fig.2 Comprehensive biocompatibility testing services.

Contact us today to discuss your testing requirements and how we can assist you in bringing your medical devices to market successfully.