MEEE Expected Service Life - IEC 60601-1 Clause 4.4 Requirements

[Mawos78]

Dear all,

I have a brief question with regards to the IEC 60601-1 Clause 4.4 "expected service life". For the Tools we are recommending a yearly service to ensure that the device (handheld motor driven drill/saw) are functioning as intended.

But I'm still struggling with the correct definition of the expected service life of these devices. Is this the time frame the device is functioning without any service has been performed (so one year would be the expected service life), or is this the time frame the device can be serviced and therefor the functionality can be ensured (here we are talking about several years)?

What is your definition of the "expected service life"? Are in your eyes the expected service life and the lifetime of the device talking about the same time frame?

Thanks a lot for your help,

martin

 

[Marcelo]

In fact, it's the time frame that the device the manufacturer created the device to work safely and thus is related to the regulatory responsibility the manufacturer has on the device lifecycle.

 

[Peter Selvey]

The lifetime is simply what you want, there is no need to justify why you selected, for example 3, 5 or 7 years. Mainly it will have a marketing and cost impact, longer to make your device look better value, shorter saves on costs for quality of parts. But it's not a safety driven figure, just economics and sales.

Once selected, though, it becomes an important input for safety related decisions, which is why it has to be declared in the risk management file. For example, if you need to judge whether a protection system is reliable, you will need to know the lifetime of the equipment in order to make a decision. A protection system for a device with 3 years life might be OK as is, but the same protection in a device with 15 years life might need periodic checking to make sure it's still effective over the lifetime.

 

[Mawos78]

Thanks for your comprehensive answers.
Following your explanations, would it be ok to label a 5year expected service life/lifetime and informing the customer through the IFU/Product Labeling that a regular service (e.g. yearly) is needed to ensure that the labeled service life can be reached?
Or do I need to label the expected service life for one year and renew it as soon as the yearly service has been performed?
Product reliability is tested for one year in our internal product develpment tests.

 

[Peter Selvey]

In IEC 60601-1, there is no requirement to label the device with the service life, or even mention it in the instructions for use (as far as I can tell).

The key point in IEC 60601-1 is to declare it in the risk management file, so it can then be used for safety related decisions.

I guess there is the potential for "expected service life" to get mixed up with warrantee or guarantee etc which are purely commercial matters. So for this reason IEC 60601-1 does not require it to be declared to the end user.