DEKRA Product Testing
Does your medical equipment comply with the latest IEC 60601 laws and regulations?
DEKRA Product Testing
Does your medical equipment comply with the latest IEC 60601 laws and regulations?
IEC 60601 certification
Certification against the IEC 60601 standard
The IEC 60601 standard is an international standard for the safety and performance requirements of medical electrical equipment. As a manufacturer, meeting basic safety standards is essential. An IEC 60601 certification not only ensures that you meet legal requirements, but it also strengthens the confidence that your customers have in the safety and reliability of your products.
IEC 60601 testing of electrical medical equipment
IEC 60601 consists of a series of standards, each addressing specific technical aspects of medical electrical equipment. IEC 60601 testing is part of the legal requirements described in the Medical Device Regulation (MDR) guidelines. It is your responsibility as a manufacturer to identify all applicable standards and recommendations documents for medical devices. Therefore, take a look at the IEC standards and CB scope and read them carefully.
What is tested according to the IEC 60601 standards?
Certify for IEC 60601 in 7 steps
The certification process
Do you want to demonstrate that you work according to the applicable standards? DEKRA's accredited testing laboratory is ready to assist you. Complying with all laws and regulations is not an easy task. That is why DEKRA's experts are ready to help you. We guide you through the entire process: from pre-compliance to certification against the necessary IEC 60601 standards.
- Step 1: IntakeWe identify your specific needs for testing and certification of your product based on your unique situation and personal preferences.
- Step 2: ScopeWe identify the standards relevant to you and inform you about which testing and certification services are available for your (complex) electrical medical equipment.
- Step 3: Quotation & RoadmapYou will receive a quote based on the requirements of your unique product. We also develop a clear step-by-step plan so that you know what to expect for your IEC 60601 certification.
- Step 4: Pre-compliance (optional)Technical evaluation – During this evaluation we identify possible non-conformities. This applies not only to all parts of your electrical medical devices, but also to the technical documentation, risk management, usability and software.GAP analysis – With a GAP analysis we compare your current compliance level with the IEC 60601 standard, so that it is clear what needs to be done to (continue to) comply with the standard.
In addition to your IEC 60601 certification
What else can DEKRA support you with regarding to IEC 60601 testing?
We guide you from start to finish through the certification process of the IEC 60601 standard. DEKRA also supports developers and manufacturers with the services below.
Start IEC 60601 testing for certification?
Get in touch with an expert
sales.nl@dekra.com
Meander 1051
6825 MJ Arnhem
Directions / routeIEC 60601 FAQ (Frequently Asked Questions)
In our experience, the early detection of non-conformities contributes to a smoother and faster testing procedure. View the 10 most important tips from our experts for good preparation for your IEC 60601 certification.
The standard is divided into various sub-standards of the overarching standard. An important part of the IEC 60601 standard is part 1 (IEC 60601-1). Examples of requirements that are described here are:
- EMC (60601-1-2 )
- Usability (60601-1-6)
- Software (60601-1-8)
- Home healthcare (60601-1-11)
Important technical documentation:
- IEC 62304 (Lifecycle of medical device software)
- IEC 62366 (usability of medical devices)
- ISO 14971 (risk management for medical devices)
The third edition of the IEC 60601-1 was published in 2005 and amended in 2012. The fourth edition will not be rolled out until 2027 or later. Until then, to sell your electrical medical devices, you must comply with the Second Amendment of the Third Edition.
Certify your electrical medical equipment to the IEC 60601 standard through DEKRA and benefit from these advantages:
- Access to a wide range of testing and certification services.
- Worldwide acceptance of test results and quality marks.
- Increased stakeholder confidence through independent certificates.
- Possibility to have medical equipment inspected by Notified Body.
IEC 60601-1-2
Do you manufacture electrical medical devices? DEKRA's experts are capable to test and certify your equipment against the IEC 60601-1-2 standard.
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IEC 60601-1-6
IEC 60601-1-6 describes the process for a manufacturer to analyse, specify, design, verify and validate usability. Discover more here.
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