Glossary Term
ISO 10993 (Biological Evaluation of Medical Devices)
Definition
ISO 10993 is a comprehensive series of international standards that provide guidelines for the biological evaluation of medical devices. It focuses on assessing the biocompatibility of materials used in medical devices to ensure they do not produce adverse biological responses when in contact with human tissues or fluids. ISO 10993 is widely used in regulatory submissions for medical devices globally.
Relevance to the MedTech Industry
ISO 10993 ensures that medical devices are safe for human use by evaluating their potential for toxicity, irritation, sensitization, and other biological risks. Adherence to this standard is critical for regulatory approval and patient safety, enabling manufacturers to systematically assess and mitigate risks associated with device materials.
Additional Information & Related Terms
Key Sections of ISO 10993
ISO 10993-1: Evaluation and Testing Overview Outlines the general principles for biological evaluation and testing.
ISO 10993-5: Cytotoxicity
Assesses the potential toxic effects of device materials on cells.
ISO 10993-10: Irritation and Sensitization
Tests for skin irritation or allergic reactions caused by device materials.
ISO 10993-11: Systemic Toxicity
Evaluates the potential for harmful effects on the whole body.
ISO 10993-17: Toxicological Risk Assessment
Provides methods for quantifying acceptable levels of leachables from device materials.
Related Terms
Biocompatibility Testing: The process of assessing material safety as defined under ISO 10993.
ISO 13485: A related standard for medical device quality management systems, often used alongside ISO 10993.
Risk Management (ISO 14971): Biocompatibility testing aligns with risk management practices for assessing material risks.
Material Selection: A critical step in ensuring ISO 10993 compliance during device design.