Annual Safety Test for Electrical Medical Equipment

Dear Forum, (I would move this to the 13485 forum if I´d known how...)

One of our customers are asking for a confirmation that the "annual safety check (necessary on most other medical electrical equipment) is not necessary.

I´m not quite sure what is being referred to as "annual safety check".
As far as I know there is nothing about this in the standards.

Could it be local regulations (customer is in Germany) or is it somewhere in the standards.

regards
temu

temujin said:

Dear Forum, (I would move this to the 13485 forum if I´d known how...)

One of our customers are asking for a confirmation that the "annual safety check (necessary on most other medical electrical equipment) is not necessary.

I´m not quite sure what is being referred to as "annual safety check".
As far as I know there is nothing about this in the standards.

Could it be local regulations (customer is in Germany) or is it somewhere in the standards.

regards
temu

Click to expand...

In the first instance, there is usually a WHS requirement that most businesses have to follow that will cover Electrical Safety Checks. Different requirements for fixed devices, office equipment, hire equipment etc as to not needed.... I doubt it.

The relation between safety standards and "checks after production" (including "maintenance") are that the checks or maintenance shall be made between defined intervals to guarantee that the risk controls on the equipment continues to function through the product life-cycle (this theory comes from the fact that regulatory requirements to manage risk are used through the product life-cycle).

So the standards (such as IEC 60601) do have the requirements for maintenance, checks or the like, but they do not specify intervals because it depends on the type of equipment, it´s components, and their related reliability. You also have to take into account the conditions of use and possibly misuse.

That said, in general manufacturers specify an annual or something verification procedures to check these characteristics.But this interval is not something that the standards define. Oh, and some regulation DO define intervals sometimes (although, taken what i said before into account, isn´t really the smartest thing to do).

They may have IEC 62353, Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment, in mind.

Even if they does, IEC 62353 does not specify testing intervals.

This technical report does contain an Annex on testing interval that says that if the manufacturer does not specify the testing interval, someone competent would have to, taking into account the fact that a range of 6-36 months is usually necessary, and that some types of equipment (for example, anesthesia machines) should have a testing interval of less than 24 months.

Anyway it´s up to the manufacturer or the competent person, taking into account the factors that i mentioned earlier.