Biocompatibility testing ensures thesafety of medical devices. As the name implies, it determines whether a
technology works with biological systems.
Medical devices can be tested forbiocompatibility to prevent inflammation, skin irritation, and toxicity.
Medical equipment and the people who depend on it must be protected.
This test is crucial for medicaldevice makers. Therefore, you must know your manufacturer's criteria. Start
with this blog on biocompatibility testing for dental materials.
Does EveryMedical Device Need Biocompatibility Testing?
Medical devices don't always needbiocompatibility 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 fordevices 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 undergosubstantially less extensive testing than surgical tools to ensure
biocompatibility.
What Are The 3 Types of Biocompatibility?
CytotoxicityTests
Everything that kills live cells iscytotoxicity. Cytotoxicity assays can assess medical device materials' effects
on cell viability and health. This biocompatibility testing ISO 10993 ensures that the materials used tomake the device don't release anything that could hurt cells, cause tissue
death, or cause an undesirable reaction.
Catheters, surgical implants, andother devices that come into close touch with bodily tissues must undergo this
kind of testing.
SensitizationTesting
Sensitization testing can determine asubstance's sensitivity to allergens or other sensitivities. This biocompatibility testing for dentalmaterials is essential to find substances that can cause allergicreactions, which could cause pain or major health problems for people who are
already sensitive.
Wearable screens and adhesive patchesare two devices that usually undergo sensitization testing before being used on
the skin.
Irritation Testing
Irritation tests evaluate whether amaterial 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 forBiocompatibility Testing of Medical Devices
As you may have previously realised,compliance rules have set standards for the biocompatibility testing for dental materials. Like in othersectors, the requirements of different standards can vary. These are a few that
stand out.
• FDAGuidelines: FDA guidelines require risk-based biocompatibility test selection.
• ISO10993-1: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.
• TheEuropean Union's Medical Device Regulation (MDR): For a device to be approved for salein 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 yourdevice, biocompatibility testing ISO 10993must 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.
