Testing solutions for active medical devices

Medical Device Testing

The Eurofins E&E network of laboratories offers a range of testing services for medical devices. We can also offer an extensive range of additional testing, certification and approval services for products that fall outside of the scope of medical devices.

Our range of services for medical devices includes but is not limited to:

Product Safety Testing

• Safety testing for active medical devices based on the international IEC 60601*1 standards family including, but not limited to
  • IEC 60601-1:2005 + A1:2012
  • EN 60601-1:2006 + A1:2013
  • AAMI ES 60601-1:2005/(R)2012 + A1:2012
  • CAN/CSA C22.2 No. 60601-1:14
• Safety testing for in vitro diagnostic medical devices to IEC 61010-2-101 and UL/CAN CSA 22.2
• IEC 62133/UL 1642 safety testing of Lithium-Ion Batteries and UL 2054 safety of household and commercial batteries
• ANSI ISO 14708-3: 2017 for active implantable neurostimulators

CB Scheme

Our Certification Bodies in Germany, Switzerland and the United States are National Certification Bodies (NCB) and the test laboratories are Certification Body Testing Laboratories (CBTL) under the international certification body scheme (CB Scheme).

EMC Testing

• Medical EMC testing for active medical devices based on the international IEC 60601*1 standards family including, but not limited to:
  • EN/IEC 60601-1-2 4th Edition

Radio/Wireless Testing

• WLAN, Bluetooth, ZigBee, GSM/GPRS, UMTS, Wireless Power Transfer (WPT), and LTE
• Ultra-low power active medical implants (ULP-AMI)
• Medical device RFID susceptibility testing
• Medical device wireless coexistence testing

Mechanical & Climatic Environmental Simulation

• Corrosion tests, IP tests, temperature shock, overpressure, temperature and altitude, faster decompression, shock and vibration etc

Performance Testing

• Functionality, energy efficiency, durability and reliability, performance claims validation

Other related testing services

• Digital Testing Services (software, functionality, interoperability)
• Cybersecurity testing
• Biocompatibility testing according to the ISO 10993 standards family and microbiological studies (GLP)
• Chemical characterisation for materials, extractable and leachable substances evaluation
• Medical device packaging testing with distribution simulation testing, fragility, shock compression testing

We offer a range of additional services through our laboratory networks including Digital testing and cyber Security, and bio-compatibility/ bio-pharmacological testing.

1. 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.

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