What is BS EN ISO 14708-1:2013 ?

EN ISO 14708-1:2013 is a technical standard that sets guidelines and requirements for the design, manufacturing, testing, and performance evaluation of implantable neurostimulators for the treatment of chronic pain. The standard is divided into two parts, EN ISO 14708-1:2013 and EN ISO 14708-2:2013.

EN ISO 14708-1:2013 provides requirements for the design, manufacturing, and testing of implantable neurostimulators, including the electrical characteristics, mechanical design, and performance requirements. It also includes guidelines for the validation and performance evaluation of these devices.

EN ISO 14708-2:2013 is focused on the performance evaluation of implantable neurostimulators, including the testing requirements and the evaluation procedures. It is intended to ensure the safety and effectiveness of these devices in the treatment of chronic pain.

EN ISO 14708-1:2013 and EN ISO 14708-2:2013 are significant standards that are essential for the development and production of implantable neurostimulators. They provide a framework for the design, testing, and performance evaluation of these devices, ensuring that they are safe, effective, and meet the needs of patients. By following these standards, manufacturers can ensure that their implantable neurostimulators are of high quality and are able to effectively treat chronic pain.