What is EN ISO 10909: 2014 ?

EN ISO 10993-7:2014 is an essential international standard that provides guidelines for evaluating the biological compatibility of medical devices. 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. It aims to identify and evaluate any potential adverse reactions at the site of contact, such as irritation, inflammation, or cell damage.

The purpose of EN ISO 10993-7:2014 is to ensure the safety and compatibility of medical devices with human beings. The standard provides guidelines for assessing the potential toxicity of materials used in medical devices when they come into direct or indirect contact with the body. It is crucial to conduct thorough evaluation to identify any potential risks associated with these materials.

EN ISO 10993-7:2014 specifies a framework for the biological evaluation of medical devices, including the assessment of the potential adverse effects of materials on living tissue and the evaluation of their biocompatibility. The standard provides guidelines for conducting tests to determine the material's cytotoxicity, sensitization potential, and irritation properties.

The standard has several key requirements that medical device manufacturers must comply with in order to demonstrate compliance. These requirements include the need for a risk assessment to identify any potential risks associated with the material, the need for testing to determine the material's cytotoxicity, sensitization potential, and irritation properties, and the need for results to be documented and reported.

In conclusion, EN ISO 10993-7:2014 is an essential international standard that provides guidelines for evaluating the biological compatibility of medical devices. It is crucial for medical device manufacturers to comply with the standard's requirements in order to ensure the safety and effectiveness of their products.