All terms
Quality & RiskQuality System
Biocompatibility
Ability of a material to perform with an appropriate host response in a specific application.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Biocompatibility evaluates how a medical device material interacts with the human body to ensure it does not produce adverse biological responses such as cytotoxicity, sensitization, or systemic toxicity.What this means in practice
Tests are selected per ISO 10993-1 based on contact category and duration. Material changes typically trigger re-evaluation.Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
FDA·2ISO·1
- 1
FDA Biocompatibility GuidanceVerifiedFDAfda.gov
- 2
FDA - Quality SystemsVerifiedFDAfda.gov
- 3
ISO 13485 Standard PageVerifiedISOiso.org
Inline markers like [1] jump to the matching reference above.