What is EN ISO 8980-6:2013 ?

EN ISO 8980-6:2013 and EN ISO 10993-7:2014 are both important international standards that play a crucial role in ensuring the safety and effectiveness of medical devices.

EN ISO 9447:2014 is a technical standard that provides guidelines for the preparation and writing of technical documentation for products. It aims to ensure clarity, consistency, and accuracy in technical communication, making it easier for users to understand and use products effectively.

EN ISO 10993-7:2014 is an international standard specifically focused 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 aims to identify and evaluate any potential adverse reactions at the site of contact, such as irritation, inflammation, or cell damage. It provides guidelines for conducting tests to determine the material's cytotoxicity, sensitization potential, and irritation properties.

The purpose of EN ISO 9447:2014 is to establish a standardized approach to technical documentation across different industries and sectors, and to ensure that technical information is clear, concise, and accurate in conveying the technical aspects of a product.

EN ISO 10993-7:2014 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 provide guidelines for evaluating the potential adverse effects of medical device materials on living tissue and to establish a framework for assessing their biocompatibility.

Both EN ISO 9447:2014 and EN ISO 10993-7:2014 are essential for ensuring the safety and effectiveness of medical devices, and are widely recognized and adopted by different industries and sectors. By following these standards, manufacturers can ensure that their products are thoroughly evaluated and validated before being brought to market, ultimately leading to better patient outcomes.