What is EN ISO 13286-10:2014 ?

EN ISO 10993-7:2014 is an essential international standard that outlines the criteria for evaluating the biocompatibility of medical devices. The standard was developed by the International Organization for Standardization (ISO) and is designed to ensure that medical devices are safe and effective for use in the human body.

The purpose of EN ISO 10993-7:2014 is to provide guidelines for assessing the potential adverse effects of medical device materials on living tissue and to establish a framework for evaluating their biocompatibility. The standard specifically focuses on the assessment of the local effects of materials used in medical devices when placed in direct or indirect contact with the human body.

The standard provides guidelines for conducting tests to determine the material's cytotoxicity, sensitization potential, and irritation properties. It also emphasizes the importance of identifying and evaluating any potential risks associated with materials used in medical devices.

To meet the requirements of EN ISO 10993-7:2014, medical device manufacturers must conduct a thorough evaluation of the potential adverse effects of their materials on living organisms. This involves a series of in vitro and in vivo testing to determine the material's compatibility with human tissue.

The standard also provides guidance on the preparation and execution of the tests, as well as the reporting of results. It is widely recognized and accepted as the benchmark for the biological evaluation of medical devices.

In conclusion, EN ISO 10993-7:2014 is an essential international standard that provides a framework for evaluating the biocompatibility of medical devices. It is widely recognized as the benchmark for the safety and effectiveness of medical devices and is critical to ensuring the safety and effectiveness of medical products.