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IEC 60601-1 Medical Electrical Equipment

Medical Electrical Equipment testing IEC 60601-1 (UL 60601-1, EN 60601, ES 60601) - TÜV Rheinland

IEC 60601-1 Medical Electrical Equipment Testing and Certification

Mark your active medical devices as safe and reliable

Medical products must complete compliance evaluation, testing and device approval before being placed on the market.

Oversight of key compliance standards can be costly to the manufacturer, especially in the areas of product redesign, compliance testing, device approval and certification turnaround time.

Our experts offer clarification on IEC 60601 series for your desired markets, in addition to the framework in which your product design and manufacturing will be evaluated. IEC 60601 series are harmonized standards recognized worldwide with several localized deviations in key markets.

Expand your market access! Certify your active medical products.

Your IEC 60601-1 compliance for global market access

Medical electrical equipment certification according to IEC 60601-1 (ISO 60601, UL 60601-1, EN 60601, ES 60601) | TÜV Rheinland
IEC 60601-1 certification and safety testing for medical electrical equipment.

The testing and certification process of fulfilling the current IEC 60601-1 standard is a complex and multifaceted task. IEC 60601-1 mandates collateral, particular and performance standards specific to the device type, all of which are required for relevant certification schemes.

Documentation of ISO 14971 compliant risk management practices must be clear throughout the product lifecycle and device labeling. In conjunction with technical documentation and device sample, your medical electrical equipment and systems are tested according to established electromagnetic compatibility (EMC) as well as, electrical and environmental safety standards.

Your intended destination markets determine whether you will require a IEC 60601-1 certificate, a comprehensive evaluation report or both.

Our experts actively participate in standardization committees to gain unique technical expertise and actively stay informed of the latest changes to compliance requirements. Speak to an expert to determine if your device is eligible for testing or requires full IEC 60601-1 certification.

Learn major market deviations and requirements – Download the IEC 60601-1 Fact Sheet

pdf Electrical Medical Equipment Factsheet 359 KB Download

Choose an experience partner for your IEC 60601-1 compliance

Comprehensive compliance testing of your medical electrical equipment and systems ensures the safety, quality and performance of your products. Our experts can help you understand the specific IEC 60601-1 standard requirements relevant to your unique product.

Advantages with TÜV Rheinland:

  • Upfront pricing
  • Wide scope of comprehensive testing services
  • State-of-the-art laboratories around the world for faster, reliable results
  • Single source provider with quick reaction time from anywhere in the world
  • Customized service packages tailored to your needs, saving you time and money.

TÜV Rheinland is one of the biggest medical scope providers worldwide. Our accredited laboratories are equipped with a wide-range of active medical device testing systems and are ready to serve you during your IEC 60601-1 certification. Choose a single source provider, receive all documents from one place, speak to experts around the clock, save time & money and get market-ready, fast.

Our market access services and multi-market certification programs, such as cTUVus Certification, CE Marking, INMETRO and CB scheme solutions for strategically entering and/or strengthening your position in competitive markets around the world.

Why TÜV Rheinland?

Our team of experts from Active Medical Devices, Medical Electrical Equipment IEC 60601-1 specialty, and Market Access Services are here to serve you and your business around the world. Have confidence in your certification options and market knowledge. Build your ideal certification package from a comprehensive list of services through a single-source provider.

We are a globally operational Certification Body with a wide range of accreditations, testing facilities and certified staff serving an extensive portfolio of customers from every industry.

Frequently asked questions

Regulatory testing standards can be complex and confusing. Here are just a few answers to some common questions. Our experts are happy to answer any further questions you may have. Speak to an expert!

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What qualifies as medical electrical equipment?

The IEC 60601 standard defines medical electrical equipment as “equipment provided with no more than one connection to a particular supply mains and intended to diagnose, treat, or monitor a patient under medical supervision and, which makes physical or electrical contact with the patient and/or transfers energy to or from the patient and/or detects such an energy transfer to or from the patient.” This also includes a variety of accessories used alongside or in conjunction to the electrical product, such as a medical grade computer and it’s parts.

Does IEC 60601-1 testing include risk management analysis?

Yes. When seeking a full IEC 60601-1 compliance, your risk management file is evaluated, of which includes ISO 14971 standard.

However, risk management evaluation is not mandatory for manufacturers requesting pre-compliance services, for customers only seeking specific/isolated testing or excluded entirely, such as in the case of applying for a CB test certificate on a component power supply.

Take advantage of the cTUVus (North America), INMETRO (Brazil) and CB Schemes (parts of Europe and Asia) to eliminate duplicated testing processes when pursuing multiple markets.

Why is IEC 60601-1 testing necessary?

IEC 60601 is a globally recognized standard for medical electrical equipment, devices and peripheral accessories. Securing an IEC 60601-1 certification paves the way for easier transitions into major markets.

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