Glossary Term
Biocompatibility/Biocompatibility Standards
Definition
Biocompatibility refers to the ability of a medical device or material to perform its intended function without causing adverse biological reactions in the body. Biocompatibility Standards are regulatory frameworks, such as ISO 10993, that define the testing and evaluation methods required to ensure a material’s safety when used in medical devices.
Relevance to the MedTech Industry
Biocompatibility is fundamental to patient safety and is required for all medical devices that come into contact with the human body. Ensuring compliance with Biocompatibility Standards reduces risks such as toxicity, inflammation, or allergic reactions, enabling manufacturers to meet regulatory requirements and achieve market approval.
Additional Information & Related Terms
ISO 10993 The primary standard for biocompatibility evaluation of medical devices.
Toxicology Testing Assesses potential toxic effects of device materials on biological systems.
Risk Management File (ISO 14971) Incorporates biocompatibility data to evaluate device safety.
Sterilization Validation Confirms that sterilization processes do not affect material biocompatibility.