Implants for surgery. Active implantable medical devices. Part 4. Implantable infusion pumps

This standard outlines the specifications and requirements for active implantable medical devices, specifically focusing on implantable infusion pumps. It covers aspects such as design, performance, testing, and safety considerations to ensure the proper functioning and reliability of these devices within the human body. The document provides detailed guidelines for manufacturers and regulatory authorities to follow in order to meet the necessary quality and safety standards. It also includes information on labeling, packaging, and storage conditions to maintain the integrity of the product throughout its lifecycle. The standard is structured to align with international norms and is applicable to devices intended for use in medical procedures requiring the controlled delivery of fluids.