Under the medical safety standard IEC 60601-1-1:2014 an EMC test lab is not required to assess or review any aspect of a Risk Management File.

08 Jan 2020

Author: Keith Armstrong

Under the medical safety standard IEC 60601-1-2:2014 an EMC test lab is not required to assess or review any aspect of a Risk Management File.

IEC 60601-1-2:2014 is a medical device safety standard that deals with safety risks that can be caused by electromagnetic interference with electronics. It is not an EMC compliance standard!

If the EMC test lab has the necessary safety risk assessment competencies, they could review/assess the RM File if specifically requested to do so by their customer.  

But we should not expect any EMC test lab to have such safety competencies – and for that reason the writers of IEC 60601-1-2:2014 (of which I am one) have made it quite clear in this standard that there is no requirement for the EMC test lab to assess any of the contents in the Risk Management (RM) File.

We stated this very clearly in subclause 4.1 of IEC 60601-1-2:2014, copied below:-

4.1 risk management process for me equipment and me systems

risks resulting from reasonably foreseeable electromagnetic disturbances shall be taken into account in the risk management process.

NOTE 1 Annex F provides additional guidance on taking electromagnetic disturbances into account in the risk management process.

NOTE 2 This standard requires the manufacturer to perform a number of activities with regard to em disturbances during the design and realization of their me equipment or me system, and to document them in the risk management file. However, EMC test laboratories cannot be expected to perform or document these activities.

Compliance is checked by verifying the presence of the corresponding entries in the risk management file.

'Notes' are not normative, but the final line in subclause 4.1, in italics, is normative text and clearly states that compliance is checked simply by verifying the presence of the corresponding entries in the RM File.

There are no requirements to do anything other than to check that, for all of the various RM requirements in 60601-1-2:2014, some text exists in the RM File.  

Even if that text is just random words, for example the common ‘lorem ipsum…’ placeholder text often used to demonstrate the visual form of a document without having any meaningful content!

It is a common misunderstanding that EMC test labs must assess the contents of the RM File as regards IEC 60601-1-2:2014, and it arises because test labs rarely read the whole of a standard. Instead, they only read the pages that describe the EMC tests they are to perform, so it is easy for them to make the incorrect assumption that they are required to review/assess the contents of the RM File that relevant to complying with this standard.

It is the job of the Regulator (e.g. FDA or EU NB) to assess whether the contents of an RM File are adequate, never the EMC test lab.

Remember: IEC 60601-1-2:2014 is a safety standard, not an EMC standard!

Of course, we do want someone to assess our RM efforts before we take the costly and time-consuming step of submitting our product to a Medical Regulator. So, we should ask a safety assessor who has the necessary competencies in safety risk management to review/assess the contents of our medical devices’ RM Files.

Suitable safety assessors will probably have had to obtain their necessary competencies working in the much larger and wider Functional Safety / IEC 61508 world, outside of the medical device industry.

With some Safety Approval Bodies it might prove necessary to get their medical safety assessors to subcontract this aspect of their assessment of our medical devices to colleagues with proven risk management competencies from working in the Functional Safety / IEC 61508 world.

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