Electrical Testing

Safety and Conformity

We test the electrical safety of your active products in accordance with internationally recognized and harmonized standards, including DIN EN 60601 and IEC 80601 for active medical devices. Our accredited test laboratory stands for quality and safety. An independent test certificate from us is clear proof of the marketability of your product and a key to your success.

Why Berlin Cert?

Comprehensive testing services for your product excellence

Wir überprüfen alle Aspekte Ihres Produkts auf mögliche Gefahren, einschließlich elektrischer, mechanischer und thermischer Risiken. Dabei gehen wir auch ins Detail und prüfen die Vollständigkeit der Angaben in der Betriebsanleitung, auf dem Typenschild und in Ihrer Risikobeurteilung.

Our range of services includes:

  • Voltage and current measurements
  • Leakage current and insulation tests
  • Assessment of dielectric strength
  • Measurement of the protective conductor resistance
  • Air and creepage distance testing
  • Power and energy consumption measurements
  • Environmental tests such as air conditioning and irrigation
  • Temperature tests
  • Signal analysis and determination of functional properties

We also offer safety checks (STK) in accordance with the MPBetreibV for active medical devices and tests of the functional properties of electrotherapy devices (TENS).

From the idea to market maturity: your partner in every phase

Whether in the development of components and prototypes or in the quality assurance of market-ready products - we support you in every phase. Our tests not only ensure conformity with standards, but also strengthen the confidence of your customers and partners in your product.

Accredited expertise: your guide to product certification

Our accreditation covers a wide range of standards, enabling us to offer you customized testing services. This also includes individual tests, specific standards

Efficiency and precision: customized solutions for you

We offer you fast and cost-effective technical evaluations for interim results in your development process to minimize potential additional costs. Our calibrated measurement technology and expert knowledge ensure that your products meet even the highest requirements.

Extended testing services: Comprehensive support for special requirements

We also offer extended testing services for special requirements, e.g. EMC testing, for medical supply applications in the domestic environment, enclosure protection class / IP testing and much more.

Your success is our goal: We are here for you

Our team is at your side from the initial inquiry through to certification. Contact us to find out more about how we can support you.

Basic Standard

  • DIN EN / IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Supplementary standards or collateral standards

  • DIN EN / IEC 60601-1-4 Medical electrical equipment - Part 1-4: General requirements for safety; Collateral standard: Programmable electrical medical systems
  • DIN EN / IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Particular standards or special requirements

  • DIN EN / IEC 60601-2-10 Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulation equipment
  • DIN EN / IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment
  • DIN EN / IEC 60601-2-25 Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
  • DIN EN / IEC 60601-2-26 Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs
  • DIN EN / IEC 60601-2-38 Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds
  • DIN EN / IEC 60601-2-40 Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked potential equipment
  • DIN EN / IEC 60601-2-47 Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
  • DIN EN / IEC 60601-2-52 Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
  • DIN EN / IEC 80601-2-60 Medical electrical equipment - Part 2-60: Particular requirements for the safety, including essential performance, of dental equipment

  • Diagnostic devices such as ECG recorders, EMG devices, blood pressure monitors, ultrasound devices
  • Therapeutic devices such as stimulation current devices, hyperthermia devices, respiratory therapy devices, magnetic field stimulation, massage stimulation, infusion pumps
  • Devices for patient monitoring (patient monitors, medical sensors)
  • Electrical devices for the operating theater (irrigation pumps, imaging systems / endoscopes, light sources, surgical tools, insufflators)
  • Electrically operated beds, wheelchairs and stair climbers
  • Electrotherapy devices / electrostimulation devices according to test method 09-03 09/2021 MDS-Hi (replaces test methods 09-01 03/2007 MDS-Hi and 09-02 03/2007 MDS-Hi) for inclusion in the GKV's list of medical aids (product group 09)
  • And many more