Medical Device Testing Contact: Email: EE@eurofins.com www.eurofins.com/EE Testing Services • Safety Testing • Safety testing for active medical devices based on the international IEC 60601 standards family; including test reports and certificates according to CB Scheme and ILAC accreditation. • Safety testing for in vitro diagnostic medical devices to IEC 61010-2-101. • Product safety compliance in the United States and Canada (FDA and Health Canada) including OSHA NRTL requirements. • EMC Testing • Medical EMC testing for active medical devices based on the international IEC 60601 standards family; including test reports and certificates. • Radio/Wireless Testing • Ultra low power active medical implants (ULP- AMI). • Medical device RFID susceptibility testing. • WLAN, Bluetooth, ZigBee, GSM/GPRS, UMTS, Wireless Power Transfer (WPT), and LTE. • Mechanical & Climatic Environmental Simulation • Corrosion tests, IP tests, temperature shock, overpressure, temperature and altitude, faster decompression, shock and vibration. • Performance Testing • Functionality, energy efficiency, durability and reliability, performance according to FDA guidance documents, claims validation. • Other related testing services • Digital Testing Services (software, functionality, interoperability). • Cyber security testing. • Biocompatibility according to the ISO 10993 standards family and microbiological studies (GLP). • Chemical characterization for materials, extractable and leachable substances evaluation. * Where IEC standards are referred to, national and regional variations are also applicable including, but not limited to; ANSI/AAMI, UL, ISO, CAN/CSA, JIS, EN, ENV, BS EN, DD ENV and BS IEC. Please enquire on a case by case basis. Your industry, our focus The concept Electrical medical equipment, also known as “active medical devices”, are controlled by stringent regional and international approval procedures which include the required testing to be performed by approved and accredited laboratories. In the field of active medical devices, these requirements are documented under the IEC 60601* standards family. This is the base for the approval procedure of Medical Electrical Equipment in most global regulatory frameworks and for compliance with the Medical Device Directive (MDD) 93/42/EEC. In vitro Diagnostic Medical Equipment requirements are documented under IEC 61010* for compliance with the In Vitro Diagnostic Medical Devices (IVD) Directive 98/79/EC.