Medical Device Testing
Our Services
Medical devices are subject to highly regulated approval procedures worldwide, which also require testing by recognized testing laboratories.
In the field of active medical devices, the specifications for these tests are described in the IEC 60601 family of standards and coordinated internationally. For example, the IEC 60601-1 (Edition 3.1) and the 60601-1-2 (Edition 4) are currently the basis for the approval of medical devices in most regulatory codes. In Europe, the EN 60601 family of standards, which is usually identical on the requirements side, has a presumption of conformance with the MDD 93/42/EEC.
In our testing laboratory, we can carry out the tests required for active medical devices market access worldwide. After successful completion of the compliance process, we issue you with test reports and test certificates in accordance with the CB Scheme. The competence of the laboratory is monitored by regular inspections by the IEC and documented on the website of the IECEE.
Product Safety Testing
We test your products against global standards including IEC 60601 to ensure your products are safe for use.
Safety testing for active medical devices based on the international IEC 60601 standards, including particular and collateral standards:
- IEC 60601-1:2005+AMD1:2012+AMD2:2020
- IEC 60601-1-4, IEC 62304 (PEMS)
- IEC 60601-1-6, IEC 62366 (Serviceability)
- IEC 60601-1-8 (Alarms)
- IEC 60601-1-11 (Use in a domestic environment)
- IEC 60601-2-10 (Stimulation)
- IEC 60601-2-27 (ECG)
- IEC 60601-2-31 (External pacemaker)
- IEC 60601-2-40 (EMG)
- IEC 60601-2-49 (Patient monitoring)
- IEC 60601-2-66 (Hearing aids)
In addition to the services offered through our location in Germany, we can also offer a wide range of services through the global network of Eurofins Electrical & Electronics laboratories, including:
- EN/IEC 62304:2006+AMD1:2015 (Software life cycle processes)
- EN/IEC 62366-1:2015 (Usability of medical devices)
- 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/EN 61010-1:2010+A1:2019+AC:2019
- EN/IEC 61010-2-101 and UL/CAN CSA 22.2 No. 61010-2-101
- IEC 60601-2-37 Ultrasonic medical diagnostic and monitoring equipment
- EN/IEC 60601-2-5 Theraputic Ultrasound & EN/IEC 60601-2-62 High-Intensity Focused Ultrasound (HIFU)
- EN/IEC 62133:2012 safety testing of Lithium-Ion Batteries
- ANSI ISO 14708-3: 2017 for active implantable neurostimulators
EMC Testing
Ensure your products meet globally recognised standards for EMC for active medical devices, such as IEC 60601 and others, allowing you to access markets and deliver compliant products to your customers.
Medical EMC testing for active medical devices based on the international IEC 60601*1 standards family including, but not limited to:
- EN/IEC 60601-1-2:2015+A1:2020
Radio/Wireless Testing
Safe & reliable data communications is an essential part of a modern medical device. Our wireless testing ensures compliance with widely used protocols and services.
- 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
Ensure your product can operate now and into the future in the harsh environments found in medical applications with our extensive range of mechanical, climatic and environmental testing services.
- Corrosion tests, IP tests, temperature shock, overpressure, temperature and altitude, faster decompression, shock and vibration etc
Performance Testing
Ensuring you can meet the performance goals for your product is key to market success. Our performance testing services allow you to exceed market demands and to demonstrate to your customers the quality of your product.
- Functionality, energy efficiency, durability and reliability, performance claims validation
Cybersecurity Testing
If you’re recording, storing or transmitting patient data, ensuring the security of that data is vital. Our Cybersecurity testing and certification services allow you to meet the cybersecurity demands of regulatory authorities and customers alike.
- EU MDR Annex I
- MDR and IVDR requirements MDCG 2019-16
- IEC 81001-5-1
- IEC 62304
Other related testing services
Alongside the services from Eurofins Electrical & Electronics, we can provide additional services from the laboratories and locations across the Eurofins network. Expand your testing and certification portfolio and grow your markets.
- 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
Our scope of accreditations and certifications.
Our scope of accreditation and range of services are updated regularly. Comprehensive information about our accreditations and current services can be found on our Accreditation page.
Contact our team of experts.
Contact our experts today to begin testing and certifying your products. We offer comprehensive testing, certification, and quality assurance services for electrical and electronic products, simplifying global regulatory compliance and accelerating your time to market.