Is a Hospital Grade Power Cord Required? Class I Medical Device

V

VikingQM

#1
We make Class 1 medical devices and test to 60601-1. I understand that any power cord I supply in the US needs to be Hospital Grade but what I am not clear on is if I must provide a cord with the device. In most cases it will be going on a cart with a power strip that would not accept a hospital grade plug.

We have always shipped units with a cord in the US and I thought it was a requirement but I cannot find where it is required.

Thanks in advance
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
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#3
A second 'bump'. Can anyone help with this one? My Thanks in advance!
 

yodon

Staff member
Super Moderator
#4
Since this is floundering a bit, I'll toss in my thoughts.

This is not my area of expertise but here's what I've picked up. I'm not sure about "hospital grade" but we have always done "medical grade" power supplies for our devices that plug in. Indeed, it's a higher level of test than commercial grade (and thus costs more). My understanding is that hospitals won't allow a product in the door unless the power supply is medical grade (UL / ETL).

Hope that's a little help. Maybe this will tickle someone else in replying.
 
V

VikingQM

#5
Re: Is a cord Required to ship Medical Device in US?

Thanks for the bumps and and thanks Yodon for your take.

Soemhow when I posted, my title/question got a bit skewed. I am not aksing about what type of cord but if I actually need to supply a cord with the product when I ship it.

I also am not sure which standard or otherwise I should be investigating to find the requirement.
Is it an OSHA requirement?
Is it a NEC requirement?
Is there a Hostpital standard that requires it?

I have spent some time researching and will continue but I thought someone might know where the requirement is/is not.

Thanks again.
 
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