ISO10993

ISO 10993 is an international standard developed by the International Organization for Standardization (ISO) that provides guidelines for the biological evaluation of medical devices. The standard is designed to help manufacturers evaluate the potential biological risks associated with their devices and ensure their safety for use in the human body.

ISO 10993 is divided into 20 parts, each covering a specific aspect of biological evaluation. Part 1 provides an overview and provides guidance on the decision-making process for selecting the necessary tests to validate a medical device. Part 5 covers tests for in vitro cytotoxicity and irritation, including the direct contact cytoxicity (TCP) test. Part 6 covers tests for cytogenetic evaluation in vitro, including mammalian cells.

The standard requires manufacturers to consider the biological evaluation of their devices throughout the design, development, and testing phases. This includes identifying potential risks, defining the limits of acceptability, and conducting necessary tests to demonstrate safety. Manufacturers are also required to document and report their results, including any findings that indicate a device may not meet the safety requirements.

Use of ISO 10993 is optional but highly recommended by regulatory bodies, including the FDA in the United States. Devices that meet the requirements of this standard are less likely to be rejected by regulatory authorities or experience commercial difficulties. Compliance with this standard enhances the reputation of manufacturers as committed to safety and improves customer confidence in the products.