What is EN ISO 10993-12:2012+A1:2015 ?

EN ISO 10993-12:2012+A1:2015 is an essential standard for medical device manufacturers, as it helps ensure that medical devices are safe and effective for use. EN ISO 10993-7:2014 is a specific standard that focuses on evaluating the local effects of materials used in medical devices when placed in direct or indirect contact with the human body.

EN ISO 10993-7:2014 provides a framework for assessing the potential adverse reactions at the site of contact, such as irritation, inflammation, or cell damage. It also provides guidelines for conducting tests to determine the material's cytotoxicity, sensitization potential, and irritation properties. By following the guidelines set out in this standard, medical device manufacturers can ensure that their products are safe and effective for use, and that they are able to provide accurate and reliable information to healthcare providers and patients.

The primary purpose of EN ISO 10993-7:2014 is to enable seamless sharing, integration, and interoperability of product data across different software applications, systems, and organizations. It helps to overcome the challenges of data inconsistency, duplication, and incompatibility that often arise when multiple software tools are used throughout the product lifecycle.

In conclusion, EN ISO 10993-7:2014 is an essential standard for medical device manufacturers that aims to ensure the safety and effectiveness of medical devices. By following the guidelines set out in this standard, manufacturers can ensure that their products are safe and effective for use and that they are able to provide accurate and reliable information to healthcare providers and patients.