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Lexicon: B
Biocompatibility
A B C D E F H I L M N P R S T U V W
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Biocompatibility

Biocompatibility is the ability of a material to elicit an appropriate host tissue response in a specific biological environment without causing toxic, immunological, or other harmful effects. The concept is central to the biological safety assessment of medical devices.

Biological evaluation of medical devices is conducted in accordance with the ISO 10993 series (Biological evaluation of medical devices). Key test endpoints by application:

  • ISO 10993-5: Cytotoxicity (cell damage)
  • ISO 10993-10: Sensitisation (allergic reactions)
  • ISO 10993-23: Irritation (local irritation)
  • ISO 10993-3: Genotoxicity, carcinogenicity, reproductive toxicity

For medical single-use gloves, biocompatibility is a requirement under EN 455-3: limits for protein content (latex gloves), water-soluble substances, and cytotoxicity.

Biocompatibility and sterility are distinct concepts: sterility means freedom from viable micro-organisms; biocompatibility describes the biological compatibility of the material itself.

Frequently asked questions

What is the difference between biocompatibility and sterility?

Sterility means freedom from viable micro-organisms. Biocompatibility describes the biological compatibility of the material itself – it must not cause harmful reactions on contact with the body. A product can be sterile but not biocompatible.

Which standard governs biocompatibility testing for medical devices?

ISO 10993 is the applicable standard series. It comprises over 20 parts covering different biological endpoints: cytotoxicity (ISO 10993-5), sensitisation (ISO 10993-10), irritation (ISO 10993-23), and others.

Why is biocompatibility relevant for single-use gloves?

Medical single-use gloves come into contact with patient tissue and body fluids. EN 455-3 therefore sets limits for cytotoxicity, protein content (latex), and water-soluble substances.