STEMart - Active Implantable Medical Device Testing Service
An active implantable medical device (AIMD) is any active medical device that is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice for diagnostic or therapeutic purposes, and which is intended to remain in place after the procedure. Since AIMDs are engineered to maintain direct contact with the body for long periods of time, they muse comply with strict standards and requirements to ensure the health and safety of patients.
STEMart helps manufacturer demonstrate the compliance of their AIMDs to safety, EMC and product-specific standards related to its purpose and function to ensure patient safety.
Applicable Standards
- EN 45502 Implants for Surgery - Active Implantable Medical Devices
- EN 60068-2 Environmental Testing
- IEC 61000-4 Electromagnetic Compatibility (EMC)
- IEC 60601 Medical Electrical Equipment
STEMart tests a wide range of AIMDs including:
- Ventricular assist systems and devices
- Cochlear implants
- Implantable cardiac pacemakers
- Implantable defibrillators
- Implantable infusion pumps
- Implantable neural stimulators
- Implantable active monitoring devices
Test Capabilities
- Biocompatibility Testing
- Microbiology & Sterility
- Electric Safety Testing
- Electromagnetic Compatibility (EMC) Testing
- Environmental Simulation Testing
- Transportation and Distribution Simulation Studies
- Sterile Barrier & Seal Integrity Testing
- Elongation, Flexion
- Extraction of Connectors
- External Defibrillation Shock