Glossary Term
ISO 14708 (Implantable Medical Devices)
Definition
ISO 14708 is an international standard that provides guidelines for the design, testing, and evaluation of active implantable medical devices (AIMDs), such as pacemakers, cochlear implants, and neurostimulators. The standard addresses functional safety, biocompatibility, electromagnetic compatibility (EMC), and performance under specific clinical conditions.
Relevance to the MedTech Industry
ISO 14708 ensures that active implantable medical devices meet stringent safety and performance criteria, minimizing risks to patients while optimizing therapeutic outcomes. It provides manufacturers with a framework to demonstrate compliance with global regulatory requirements.
Additional Information & Related Terms
Key Sections of ISO 14708
ISO 14708-1: General Requirements for Safety and Performance
Covers core safety and functionality requirements for all AIMDs.
ISO 14708-2: Cardiac Pacemakers
Focuses on specific requirements for active implantable cardiac pacemakers, including battery life and pacing reliability.
ISO 14708-3: Cochlear Implants
Provides guidelines for auditory prostheses to ensure safe and effective sound transmission.
ISO 14708-4: Neurostimulators
Details safety and performance standards for neurostimulators used in pain management or neurological disorders.
ISO 14708-5 to -7
Addresses other AIMDs, including infusion pumps and cardiovascular implants.
Related Terms
Active Implantable Medical Device (AIMD): A category of devices regulated under ISO 14708.
Biocompatibility Testing: Ensures materials used in AIMDs are safe for implantation.
Risk Management (ISO 14971): A complementary standard for identifying and mitigating risks in AIMDs.
Electromagnetic Compatibility (EMC): A critical performance attribute addressed in ISO 14708.