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 IEC 60601-1 testing and certification, helping you navigate compliance efficiently with our CBTL-accredited testing services.

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What is 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 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.

Why choose Kiwa for IEC 60601-1 testing?

Tailor-made testing solutions

Every project is unique, and we provide customized 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: Certification within two weeks

We understand that time to market is critical. Our CBTL-approved laboratory offers IEC 60601-1 and EN 60601 testing with a lead time of just 10 days to 2 weeks, 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 all compliance requirements.

  1. Project kickoff: Define your requirements and compliance goals.
  2. CBTL-accredited testing: Conduct electrical safety, EMC, and cybersecurity assessments.
  3. Certification: Receive your IEC 60601-1 / EN 60601 certification.
  4. Market access: Launch your product with confidence.

Contact Kiwa today

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