12 Volt Medical Suction Equipment - Which Standard Applies?

S

SteveK

ISO 10079-1 Medical suction equipment – Part 1: Electrically powered suction equipment – Safety requirements. The opening section of this standard indicates:
“….this part of ISO 10079 addresses only mains electricity- and battery-powered suction equipment.”

Note: Part 2 covers manual suction and Part 3 covers equipment powered by a vacuum or pressure source.

Probably a pointless question but here goes, what standard (if any) do I use to approve/test suction equipment (with no internal battery etc) which is powered by a 12 Volt source i.e. from an adaptor (as per a laptop)?

Any thoughts?

Steve
 

Marcelo

Inactive Registered Visitor
Re: 12 Volt Medical Suction Equipment - which Standard?

Part 1.

Your equipment is mains connected.
 
S

SteveK

Hi Marcelo,

Well not totally convinced – that’s why I asked since there other 12V sources e.g. a wind-up charger, solar etc. Although I see your point, it is still not being ‘directly’ attached to the mains (240V in the UK) i.e. there are not the same safety related concerns such as the degree of protection required if this were the case.

Steve
 

Pads38

Moderator
I tend to agree with Marcelo.

And 60601 has specific requirements for an external power supply.

You MAY be able to claim that the power supply only needs to provide Operator protection (ie 2 x MOOP) and thus use a cheap of-the-shelf PSU.
 

Marcelo

Inactive Registered Visitor
Steve

IEC standards generally divide equipment between mains connected and internally powered. If not internally powered (your case) then it is mains connected.

ou are right about the different safety related concerns. Examples like the use of an external power supply such as the ones for laptops were the main drive to the separation of safety requirements in third edition between MOOP and MOPP. You can now have an IEC 60950 mains connected external power supply which will be a MOOP and then have more stringent requirements (MOPP) for the rest of the device.
 
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