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Medical equipment according to IEC 60601
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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?

    Electrical medical devices are susceptible to electromagnetic field interference from power and interface cables and other external influences such as mobile phones, security gates and so on. The IEC 60601 standard describes that equipment may not cause disturbances in the environment by generating excessively strong magnetic fields. An EMC test (electromagnetic compatibility test) confirms that your devices meet the electromagnetic compatibility criteria.

    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.

    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.

      Regulatory approval

      Obtain regulatory approval through DEKRA's Notified Body. Please note that regulatory approvals may run concurrently with our compliance testing procedures.
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      IEC 60601 FAQ (Frequently Asked Questions)

      How can I avoid non-conformity during my IEC 60601 certification?
      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.
      What are relevant IEC 60601 standards and documentation?
      When will the latest edition of the IEC 60601 standard be released?
      Why is DEKRA the right choice for your IEC 60601 compliance?
      Is DEKRA accredited for the IEC 60601 standard?