EBME Forums Forums Management Medical Equipment Management 60601-1

Can anyone help on what the latest standard is regarding battery operated devices - does battery operated devices require approval.

I live in Canada and battery operated devices require CSA approval but I can't find where the standard for this comes from?

depends if these are replaceable battery of embeded battery which is charged via external or internal charger.

Take a look at this document.

A device being battery operate or connected to a mains supply would still need to meet the regulatory requirements of the country in which is to be marketed. In many cases IEC 60601-1 would be used as a route to conformance. No escape from regulatory requirements just because it is battery operated!

I don't necessarily disagree but if a device is battery operated what regulation determines the regulatory requirement - especially when the nurse managers have their own budget and purchase NIBP, TENs units from the local drug store ( chemist, BOOTS). One for home use NO CSA mark in Canada but if it comes into the hospital it has to have a CSA approval. Same as pulse oximeters purchased from China small compact cheap not used for diagnostic but spot checks - should these be covered?

Who decides or which regulation do these fall under

1) "Should these be covered"? ... yes.

2) "Who decides"? ... central government.

3) "Which regulation(s) do these fall under"? ... MDR in the UK.

SOR/98-282 in Canada?

Meanwhile ... it sounds like someone needs to get a grip of equipment purchasing where you are. Don't your biomeds insist on new (incoming) equipment being commissioned by them? Do you have (and carry out) a PM programme? If nurses are buying rubbish, and using it on the wards, if I were you I would take a good look at that stuff during my next "walk through inspection". If cheap junk "fails" in any way, I would have them remove it (or better still, bin it myself).

To my mind, the circumstances you outline illustrate in part the case for regulation ... not to mention the need for vigilance - and PM - by hospital biomeds, as well as clear policies laid down by hospital management.

I don't disagree and yes we do have incoming inspection and PM program but that does not stop Nurse managers purchasing equipment from a local drug store.

The item purchased are suitable for their needs and it is difficult to remove these items as they test OK with our NIBP simulator or oscilloscope (tens).

The trouble with Canada is each Province is responsible for Health Care which includes funding and can set their own rules I believe.

On that note is there an updated version of 60601 that perhaps covers battery operated devices?

If you are already testing them, then I fail to see the problem.

Are you trying to avoid responsibility for these items?

If new kit is being brought into the hospital without being passed by you (for acceptance and commissioning), then perhaps you need to start "flexing muscles" ... and (if push comes to shove), even refuse to support it.

I guess I am not explaining myself properly. I am not trying to avoid any device - maybe lack of leadership from previous management but we were accepting battery operated devices without any approval from the appropriate certifying authorityie CSA, UL but must have a c at the eight 'O' clock position same as TUV etc.

Now one of our wonderful Engineers with our Electrical Inspector for the Province deems we must have this mark on battery operated devices ( Canada does not recognise the CE mark). Where does this authority/regulation come from?

The current version is IEC 60601-1:2005 Amendment 1:2012 + Corrigendum July 2014.
In the definitions "supply mains" has the note "This also includes battery systems..."
Section 7.3.3 covers Batteries, as does 7.9.2.4 (Electrical Power Source), and the whole section 15.4.3 (Batteries).
The annex even has a figure A.23 showing a battery!

We can therefore say battery operated equipment is entirely within the scope of IEC 60601-1.

The law in Canada is found here: https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/index.html#docCont
Guidance can be found here: https://www.canada.ca/en/health-can...s-under-medical-devices-regulations.html