Medical Device Biocompatibility 101

Biocompatibility testing ensures the safety of medical devices. As the name implies, it determines whether a technology works with biological systems.

Medical devices can be tested for biocompatibility to prevent inflammation, skin irritation, and toxicity. Medical equipment and the people who depend on it must be protected.

This test is crucial for medical device makers. Therefore, you must know your manufacturer's criteria. Start with this blog on biocompatibility testing for dental materials.

Does Every Medical Device Need Biocompatibility Testing?

Medical devices don't always need biocompatibility testing. The kind and duration of the device's contact with the body determine the necessity of testing. Specific devices may not be required to undergo testing at all if they are determined to have little to no direct interaction with patients.

Rigid testing is necessary for devices like implants that come into contact with the body for an extended period or perhaps permanently. Conversely, thorough testing might not be required for external devices that do not touch the body directly (or touch it only briefly). No matter how short the testing, all devices that come into contact with the body internally must undergo rigorous testing.

For example, cast covers undergo substantially less extensive testing than surgical tools to ensure biocompatibility.

What Are The 3 Types of Biocompatibility?

Cytotoxicity Tests

Everything that kills live cells is cytotoxicity. Cytotoxicity assays can assess medical device materials' effects on cell viability and health. This biocompatibility testing ISO 10993 ensures that the materials used to make the device don't release anything that could hurt cells, cause tissue death, or cause an undesirable reaction.

Catheters, surgical implants, and other devices that come into close touch with bodily tissues must undergo this kind of testing.

Sensitization Testing

Sensitization testing can determine a substance's sensitivity to allergens or other sensitivities. This biocompatibility testing for dental materials is essential to find substances that can cause allergic reactions, which could cause pain or major health problems for people who are already sensitive.

Wearable screens and adhesive patches are two devices that usually undergo sensitization testing before being used on the skin.

  Irritation Testing

Irritation tests evaluate whether a material irritates skin or mucous membranes. They are performed to prevent discomfort, inflammation, and tissue damage from contact. Wound dressings and other personal protective equipment, such as gloves, must undergo this testing because of the potential harm they cause to delicate skin.

 Standards Set By the FDA, the EU, and ISO for Biocompatibility Testing of Medical Devices

As you may have previously realised, compliance rules have set standards for the biocompatibility testing for dental materials. Like in other sectors, the requirements of different standards can vary. These are a few that stand out.

• FDA Guidelines: FDA guidelines require risk-based biocompatibility test selection.

• ISO 10993-1: This standard describes testing medical equipment for biocompatibility before contact with living things. It also outlines a procedure for managing risks, including recommendations for tests depending on the type and length of physical contact.

• The European Union's Medical Device Regulation (MDR): For a device to be approved for sale in the market, its technical documentation must include a thorough evaluation of its biocompatibility. This involves showing that the product satisfies all applicable performance and safety standards and follows ISO 10993 standards.

Conclusion

When selecting components for your device, biocompatibility testing ISO 10993 must be considered from the beginning. If you need to become more familiar with this and still have questions, it's best to work with a professional who specializes in biocompatibility. They can guide you in the proper direction.