COVID-19 AND YOUR ELECTROMEDICAL DEVICES

In this period of health crisis, do you want to contribute to the collective effort by supplying French or foreign hospitals with infusion pumps, respirators, syringe pumps or medical beds that comply with current standards? Sopemea and Apave Certification, specialized subsidiaries of the Apave Group, can help you bring electromedical equipment to market quickly.

There are 2 million medical devices in use in France, with a wide variety of technologies and uses: respirators, syringe pumps, monitoring systems, medical beds, and even invasive products such as an artificial heart. Their marketing in the European Union is subject to prior CE marking and testing.

What are the steps to become CB Scheme certified?

• You must have your devices tested and evaluated by a CBTL (Certification Body Testing Laboratory).
• The testing laboratory submits the test report to the certification body for decision on CB Scheme certification.
• After analysis, the certification body (NCB National Certification Body) issues the CB certificate, which allows you to access the IECEE member countries.

Why test electromedical devices?

Performing tests means ensuring that your products comply with the IEC/EN 60601 series of standards for electrical safety and EMC (Electromagnetic Compatibility), as well as the complete evaluation of your product for CE marking. Experts in functional safety can also assist you with the software part and compliance with the EN 62304 standard. 

In the field of electrical safety, you can have your product checked for potential electric shock hazards, construction, or even instructions. There are also other tests and analyses to take into account the routing of products and to qualify their behaviour in their packaging under simulated transport conditions according to physical, mechanical and climatic constraints (temperature, humidity, altitude), including for the software necessary for its proper functioning. 

EMC tests verify, among other things, the behavior of medical devices in the presence of electromagnetic sources generated by communicating devices, cell phones, laptops, tablets, Bluetooth Wifi devices...

At the end of these tests, you can have your products certified according to the target market.

Why get your electromedical device certified according to the CB Scheme?

The CB Scheme gives you access to foreign certification marks: the international recognition system is based on a unique approach, reducing both testing costs and time to market.
Obtaining it guarantees the conformity of your products by an independent third-party certification body (NCB). You then have an "international passport" that facilitates access to the markets of IECEE (IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components) member countries.

How can the Apave Group help you in this process?

For product testing, Apave has laboratories for electrical product conformity testing, EMC testing and environmental testing (climatic, vibration) so that your electromedical devices are tested according to applicable standards. We can support you from the development phase of your product, from document or prototype pre-analysis, and organize your pre-evaluation tests (dielectric, ground continuity or leakage current, EMC). Apave Group laboratories, including Sopemea and AEMC Lab, are accredited by COFRAC and IECEE (international recognition - CB Scheme). 

As part of IECEE certification, test reports are sent to Apave Certification for analysis and decision making.
Apave Certification is registered in the IECEE Scheme as NCB (National Certification Body) for the IEC 60601-1, IEC 60601-1-X and IEC 60601-2-X series of standards, concerning the general requirements for basic safety and essential performance of medical electrical equipment, including:

• IEC 60601-2-10: nerve and muscle stimulators
  IEC 60601-2-24: infusion pumps and controllers
  IEC 60601-2-52: medical beds

Apave Certification is also accredited by COFRAC under ISO 17065 for these activities, for which SOPEMEA is CBTL (IECEE) / COFRAC under ISO 17025.

These recognitions allow you to present your files to the recognized organizations in the different states (notified bodies in Europe).

All necessary sanitary measures are implemented to protect our employees and our customers during the services.