EN IEC 60601-1

EN/IEC 60601-1 testing and certification for medical devices

For manufacturers, importers, and developers of medical devices, ensuring electrical safety is a critical step in meeting regulatory requirements and achieving fast market access. At Kiwa, we specialize in EN/IEC 60601-1 testing and certification, helping you navigate compliance efficiently with our CBTL-accredited testing services.

What is EN/IEC 60601-1?

IEC 60601-1 is an internationally recognized standard for the electrical safety of medical devices. It defines essential requirements to ensure that electrically operated medical equipment is safe for both patients and healthcare professionals. Compliance with this standard is often mandatory for regulatory approval in markets like Europe (EN 60601-1), the United States, and other global regions.

The En/IEC 60601-1 standard covers:

Basic safety and essential performance requirements for medical electrical equipment.
Protection against electrical shocks, mechanical hazards, and excessive radiation.
Testing for electromagnetic compatibility (EMC) and cybersecurity.
Risk management and usability considerations.

Find more information on www.iecee.org.

Why choose Kiwa for EN/IEC 60601-1 testing?

Tailor-made testing solutions

Every project is unique, and we provide customized EN/IEC 60601 medical device testing to meet your specific needs. Whether certifying a new or existing device, our experts ensure clear communication and efficient testing processes.

Fast lead times

We understand that time to market is critical. Our CBTL-approved laboratory offers IEC 60601-1 and EN 60601 testing, ensuring your product is certified quickly and efficiently.

Comprehensive testing services in one place

Kiwa provides an integrated approach to medical device certification and safety, including:

Electrical Safety Testing (IEC 60601-1 / EN 60601)
Cybersecurity Evaluations
EMC Testing for Medical Devices
Regulatory Advisory Services for IEC 60601 medical compliance

Your path to IEC 60601-1 medical certification

Navigating regulatory changes can be complex. Our specialists offer expert advisory services on new IEC 60601 medical safety standards, ensuring your device meets compliance requirements.

Project kickoff: Define your requirements and compliance goals.
CBTL-accredited testing: Conduct electrical safety, EMC, and cybersecurity assessments.
Certification: Receive your IEC 60601-1 / EN 60601 certification.
Market access: One step closer to launching your product with confidence

Contact Kiwa today

Ensure your medical device meets EN/IEC 60601-1 safety standards with CBTL-accredited certification. Get in touch with our IEC 60601-1 testing lab.

Frequently Asked Questions (FAQ)

What is IEC 60601-1 certification?
Who needs IEC 60601-1 certification?
How long does the certification process take?
What is the difference between IEC 60601 and EN 60601?

IEC 60601 is an international standard developed by the International Electrotechnical Commission (IEC) for the safety and performance of medical electrical equipment. EN 60601 is the European version of this standard, adopted by the European Committee for Standardization (CENELEC). While the core requirements are the same, EN 60601 may include additional European-specific modifications or harmonization with EU regulations, such as the Medical Device Regulation (MDR). Manufacturers selling medical devices in Europe should ensure compliance with EN 60601 to meet EU regulatory requirements.
What is a CBTL, and why is it important?
Can Kiwa help with other medical device compliance requirements?
How can I prepare for IEC 60601-1 testing?
Where is Kiwa’s CBTL testing facility located?
How does IEC 60601 relate to medical device compliance?

IEC 60601 is a series of standards that address specific technical aspects of medical electrical equipment. Compliance with these standards is part of the legal requirements under the Medical Device Regulation (MDR). As a manufacturer, it is your responsibility to identify and follow all applicable IEC standards and relevant recommendations for your medical devices. Be sure to review the IEC standards and CB scope thoroughly to ensure full compliance.
What does 60601-1 certification cost?
When can we start?