TS EN ISO 10993-1 Biological Evaluation of Medical Devices

Explaining the requirements and testing methods for biological evaluation of medical devices, the EN ISO 10993-1 standard is actually a European standard and has been re-published by the International Standards Organization (ISO).

A medical device or material that comes into contact with the patient's body must perform its intended function without any negative effects on the patient. Potential side effects can be short-term (acute) or long-term (chronic) effects, such as mutagenic effects. Therefore, medical devices are generally subjected to a biocompatibility test to evaluate the interaction between a device and patient tissue, cells, or body fluids. The main purpose of this is to protect the patient against potential biological risks.

The EN ISO 10993-1 standard is the most widely used standard for assessing the biocompatibility of medical devices and materials. This standard provides a framework for determining appropriate biocompatibility steps. The specific tests to be performed depend on the type of medical device or material, its intended use, and the nature and duration of the contact between the medical device and the body.

The main tests that fall within the scope of the standard are tests such as evaluation, cytotoxicity, sensitization, irritation or intradermal reactivity, systemic toxicity, subchronic toxicity, genotoxicity and implantation for biological effects caused by exposure of a medical device or material to the human body. These tests are based on Good Laboratory Practices and ISO / IEC 17025 standard. It must be done in an accredited laboratory operating in accordance with its principles.

The standard in question was published by the Turkish Standards Institute (TSE) in our country with the following title: TS EN ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and experiment in a risk management process.

Within the scope of protective clothing tests, TS EN ISO 10993-1 Biological evaluation test services of medical devices are also provided by our organization.