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IEC 60601 just got amended

Second Amendment for the IEC 60601 series of standards released

IEC 60601 just got amended

Recently the IEC published updates to the IEC 60601-1 and its collateral or horizontal standards. All being part of what is referred to as the Amendment 2 project. The technical committees involved in developing and maintaining the standard have selected from all known issues and feedback the items concerning;

  • Safety gaps
  • Known problems for regulatory bodies
  • Inconsistencies within the standard(s)
  • Technical errors
  • Update key standard reference

based on voting by the committee members. Other issues are postponed to future editions.

The structure of the IEC 60601 series

The IEC 60601 series covers Medical Electrical Equipment and Systems. It consists of a general or main or base standard, the IEC 60601-1. Then there are several IEC 60601-1-X standards, called collateral or horizontal standards. They cover topics common to various types of devices like EM Disturbances, Usability, Alarms, etc. The standards, called particular or vertical standards are device type specific. Then there are IEC/ISO 80601-2-X standards. These are also particular standards or vertical standards which were co-developed with ISO.

The updated standards

The amended standards released are the main standard and its collaterals:

  • IEC 60601-1 Medical Electrical Equipment (base) – substantial
  • IEC 60601-1-2 Electro Magnetic Disturbances – substantial
  • IEC 60601-1-6 Usability – minimal
  • IEC 60601-1-8 Alarms – substantial
  • IEC 60601-1-9 Environmental Conscious Design – minimal
  • IEC 60601-1-10 Closed Loop Control Systems – substantial
  • IEC 60601-1-11 Home Healthcare Environment – minimal
  • IEC 60601-1-12 Emergency Medical Services Environment – minimal

The standards with substantial changes have updated clauses and new clauses. The others have minimal changes, say just editorial, references or clarifications only.

Particular standards were not included in the amendment project and are planned to be updated in the next 3 years. If your product also depends on a particular standard, you should wait for your particular to be updated as well. A notorious peculiarity of the IEC 60601 series of standards is that you cannot mix different editions. In other words, if your medical device is in scope of one of the particular standards, you would be able to start transitioning to the Amendment 2 project standards only once your specific particulars are aligned to them.

What is happening next?

Two things need to happen next before industry can transition to the new IEC 60601 amendment 2 standards.

  1. The IECEE will need to develop Test Report File templates from these standards. These TRFs then need to be adopted by the test labs and certification bodies prior to any testing whatsoever can take place.
  2. Parallel to that process, the regulators need to make up their mind as to if and how to adopt these new standards in the existing regulatory framework. In the best case scenario, that could easily take half a year or more after publication of the standards by the standardisation organisations. Regulators will then also define your transition period.

And if you are on the EU market, then there’s the complication of the completely halted harmonisation process. This means that the Notified Bodies to decide when to start accepting Amendment 2 standards test reports as proof of compliance. However, it is a fairly safe assumption that most Notified Bodies would adopt these standards as ‘state-of-the-art’ once the TRFs are available and testing can start.

My product compliance relies on IEC 60601, what should I do?

Determine if your product compliance relies on one or more of the amended standards. Determine if compliance of your product also relies on any particular 60601 standards (being any IEC 60601-2-X or IEC/ISO 80601-2-X), if so keep an eye out for updated particulars. As you can’t mix editions within the IEC 60601 series. Once your particulars have updated, you can follow suit as soon as your particular standards are released. If you don’t depend on any particular standards, you can take the following as a guide.


You have a product on the market

Plan a gap assessment between 6 and 12 months from now. These are best done once the TRFs have become available. And, if you are in the EU market, discuss the gap and transition with your Notified Body and go from there. There’s no harmonization expected anytime soon, but there’s still ‘state-of-the-art”.

You have a product in development and plan to test and certify soon

If your development planning is to go through testing and certification in the coming months, you can proceed the process as planned. As the standards are just released, there’s time enough to adapt, as regulators and test labs etc. need to adapt first to the new to be developed TRF’s.

You have a product in development and plan to test and certify in 1 to 3 years from now

The later you are planning testing and certification, the wiser it is to include these new standards into your design and testing strategy, and certify against these standards. Make a gap analysis in the upcoming 12 months to know the impact on your product. For EU, discuss with your Notified Body early in submission process.

If you feel you could use help with; performing the gap analysis, determining the best change strategy for your specific product / market case, or with updating your technical documentation, Unitron Regulatory can help. Even if you have another regulatory question concerning your product, reach out to Unitron Regulatory. We will gladly help you find answers.