Electrical medical device testing and certification
IEC 60601 is a series of technical standards for the safety and essential performance of electrical medical devices. This widely accepted benchmark is viewed as a requirement for most markets. The standards consists of a general standard (IEC 60601-1 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance) as well as several collateral and particular standards. DEKRA offers accreditation for most of these standards. To prevent non-conformities view 10 useful tips here.
Why is it important to test with an accredited test laboratory?
Electrical Medical Devices need to be safe for both users and patients. Complying to the applicable standards proves that your product is widely accepted to be safe.
Complying with the essential performance standards protects you against unacceptable risk.
Complying with the standards from an early stage in your research and development process prevents costly redesigns and even more costly market withdrawals. DEKRA provides guidance for a First Time Right approach.
Testing against harmonized standards leads to easier access to markets around the world. As a global partner for safety, we are involved in international recognition procedures such as INMETRO and NRTL approvals.
Choose DEKRA for electrical medical device testing and certification
1. Experienced
Our experience in this field speaks for itself. You are in safe hands with DEKRA. As the manufacturer or designer, you know your product best. We know the standards, have professional testing facilities and long-standing experience in certifying products. This provides all the ingredients for a reliable and fast-track route to market – and time is of the essence.
2. Accredited Test Laboratorium (CBTL)
As Hunter S Thompson is quoted as saying: “Anything worth doing, is worth doing right”. As a Dutch Accreditation Council (RvA) test laboratory, a high standard of quality can be expected from our engineers, our reporting and our project management.
3. Extensive scope
Our scope includes most safety standards for the ISO 17025 as well as for the CB certification. If necessary, we can also discuss a scope extension based on a long-term partnership. To clarify your specific needs, please get in touch with one of our sales managers for a detailed discussion.
4. EMC, Wireless and RED
Besides the 60601-related standards, we have a well-equipped laboratory with comprehensive EMC & Wireless testing capabilities including 60601-1-2 for Medical Equipment at our facilities in Arnhem, the Netherlands. And if needed we have the backup of multiple DEKRA locations throughout Europe and the world. Additionally, DEKRA also performs checks against EG conformity guidelines for low voltage and RED. See our scope here.
5. Technical documentation
When preparing the technical documents as part of the EG conformity assessment in accordance with the essential requirements of Directive 93/42/EEC (MDR), we check whether medical devices comply with the criteria of the IEC/EN 60601 series of standards. As part of these tests, DEKRA also tests the conformity with the requirements of IEC 62304 (software life cycle), IEC 60601-1-6 / IEC 62366 (usability) and ISO 14971 (risk management).
6. Multi-market certification programs
Do you intend to sell your product on the US/Canadian market? We are NRTL accredited under our cDEKRAus mark, meaning we’ve got you covered.
Electrical medical device testing and certification services we can help you with
- Intake – Define the roadmap to testing and certification
- Guidance - DEKRA works together with you to identify the applicable standards and provides testing and certification for (complex) electrical medical devices
- Engineering Review – DEKRA’s pre-compliance check forms the basis for gap analysis to identify possible non-conformities, not only within the electrical medical device, but also in the technical documentation, risk management, usability and software
- Gap Analysis – DEKRA gladly supports you by making a GAP-analysis between your current certification and the state-of-the-art 60601 standard, so it is clear what needs to be done to continue to comply with the standard.
- Testing and Certification – DEKRA’s experienced engineers will test your product according to the relevant standards and, when applicable, certify your product
- DEKRA Mark – The DEKRA Mark is a certification mark that demonstrates that your product has been thoroughly tested and meets all required safety standards. As the DEKRA Mark is based on internationally accepted and recognized standards, it is your product’s passport for worldwide market access.
Working together with our customers during the whole process establishes a relationship based on trust, transparency and reliability.
In our experience, early non-conformity detection results in a smoother and faster test procedure.
We will guide you through this process step by step, as we have done for so many before you.
Why get all your testing done by one provider?
- Single point of contact
- Minimal testing required
- Optimal communication lines
- Minimal sample transportation
- Transparency regarding non-conformities
- Shortest time to market
Your roadmap to successful certification of your e-medical devices
See below our roadmap
Possible next steps:
Getting your electrical medical devices certified for global market access is not an easy task. By taking each of the seven steps we will guide you through the certification process from start to finish. After your device or product is certified by DEKRA the following steps can be necessary as well:
- Regulatory approval: Obtain regulatory approval via DEKRA Notified Body. Please be aware that regulatory approval can run parallel and therefore simultaneously with our compliance testing procedure for safety and EMC & Wireless testing.
- Multi-market certification programs: With a CB Certification your product is ready for a smooth certification process in other parts of the world outside of Europe. For example, if you want to sell your electrical medical devices in the US or Canada, our NRTL-accredited laboratory is ready to help you with your CB-certification for the North-American market, the cDEKRAus product certification mark, INMETRO certification requirements and more.
Take the first step to get your e-medical device certification
Do you have a question? Get in touch with one of our experts