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60601-1 #74897 12/02/20 8:46 PM
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williamss Offline OP
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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?

Re: 60601-1 [Re: williamss] #74898 13/02/20 10:08 AM
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Stargolf Offline
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depends if these are replaceable battery of embeded battery which is charged via external or internal charger.

Re: 60601-1 [Re: williamss] #74901 13/02/20 3:00 PM
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Geoff Hannis Online Content
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Take a look at this document. smile


If you don't inspect ... don't expect.
Re: 60601-1 [Re: williamss] #74904 13/02/20 6:31 PM
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MikeX Offline
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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!

Re: 60601-1 [Re: williamss] #74925 18/02/20 2:04 AM
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williamss Offline OP
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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

Re: 60601-1 [Re: williamss] #74927 18/02/20 11:03 AM
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Geoff Hannis Online Content
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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). frown

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.


If you don't inspect ... don't expect.

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