According to ISO 10993, how is biocompatibility primarily defined?

A Ability to integrate with surrounding tissues without immune rejection

B Capacity to perform with appropriate host response

C Material’s chemical stability within a biological environment

D Resistance to microbial colonization and biofilm formation

Solution

Correct Answer: Option B

- According to ISO 10993, biocompatibility is primarily defined as the capacity of a medical device or material to perform with an appropriate host response in a specific situation.
- This means that the material or device, when introduced into the body, should not cause any harmful effects and should function as intended within the biological environment.

- It is important to note that biocompatibility is not solely about avoiding immune rejection or chemical stability but encompasses a broader perspective involving the interaction between the material and the biological system, ensuring that the response is acceptable and does not compromise the health of the patient.

Option 2, "Capacity to perform with appropriate host response," best captures this holistic definition as outlined in the standard.

Key points:
- Biocompatibility focuses on appropriate host response.
- It involves functional performance without causing adverse effects.
- It is a broader concept beyond just immune integration or chemical stability.

Reference: Biocompatibility of Medical Devices, Volume 1, Chapter 2, Page 45

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