IEC 60601 certification
Electrical medical device testing
IEC 60601 is the international standard for the safety and performance requirements for electrical medical devices. IEC stands for International Electrotechnical Commission. Testing against the appropriate set of standards is part of the compliance process regarding the Medical Device Regulation (MDR).
Electrical medical devices (active devices) are defined as any kinds of electrical equipment that have an applied part or transfer energy to or from the patient or detect such energy transfer to or from the patient.
The best way to demonstrate compliance with the relevant standards is to work with an accredited test laboratory that can provide the relevant detailed report as input for your device’s technical report. The most relevant standards for electrical medical devices are listed below:
- Product safety
- Usability
- Electro Magnetic Compatibility (EMC)
- Radiofrequency
- Software and Cybersecurity
- Relevant standards and guidance documents
For Class I devices, a self-declaration is sufficient to obtain a CE marking in order to sell your product within the EU. Compliance with the relevant standards (for example the 60601 safety standards) should still be part of your technical file.
For Class II and upwards, the risks increase and it will be necessary for a Notified Body to assess your compliance with the Medical Device Regulation (MDR) on the basis of your technical file. The reports and certifications relating to the applicable standards for your electrical medical device form part of this technical file.
The usability engineering process enables the manufacturer to assess and mitigate the risks associated with the utilization of the medical device (both correct use and usage errors) to enhance safe usage of the device for all stakeholders.
Electrical medical devices are susceptible to external electromagnetic fields, distortions via supply and interface cables or other external influences like mobile phones, anti-theft gates, etc. Another aspect is that the medical electrical device should not interfere with the environment by emitting fields that are too strong. Click here for more information.
The interconnectivity trend has also reached the world of electrical medical devices, and ever more manufacturers are designing products that include wireless connectivity. These are interesting developments, but they are not without some risk. Wireless communication (RFID, Bluetooth, Wi-Fi, 5G, etc.) also needs to comply with the relevant standards (for example the 301489 series, and many more).
Software can be embedded in a medical device or be stand-alone software. Software is mainly found in active devices. Stand-alone software is considered to be an active medical device when associated with a medical device.
- 60601-1 series, including:
- collateral standards 60601-1-xx
- particular standards 60601-2-xx
- 60601-1-2 considers EMC
- 60601-1-6/62366 considers usability
- 62304 Medical Device Software – software life-cycle processes
It is the responsibility of the manufacturer to have identified all applicable standards and guidance documents for their medical device. For more details see our IEC standards and CB scope.
IEC 60601 certification Version 3.2
The third edition of 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. Would you like to know more about the impact of the change on your medical devices? Fill in your contact details via the form below and you will receive our free whitepaper ''Update 60601 version 3.2: what has changed?'' by e-mail.
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