Not sure what standards apply to non-electrical patient bed

M

milagre

#1
Hello everyone,

This is my first time posting here, so if anything is wrong (like the forum I selected?) please let me know.

I have been asked to look into standards relating to a non-electrical hospital bed. Specifically, the bed would be for infants. Our end goal would be to achieve a CE mark for the bed.

I am currently having a hard time identifying the applicable standards for this project. IEC 60601-2-52:2009 relates to hospital beds, but it is specifically for ME equipment.

The bed is made of a metal support system, a large bassinet that is held by the metal support, and a mattress inside the bassinet. The bassinet and mattress are purchased from a supplier and are 10933-1 compliant. It may also be of note that the bed has lockable wheels and a shelf

I assume there is some standard this bed needs to comply to that has similar requirements to the non-electrical tests seen in 60601-1.

Any advice on how to go about locating the applicable standards would be much appreciated.
 
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S

SteveK

#2
From the BSI site I found these current standards:

BS EN 12531:1999
Castors and wheels. Hospital bed castors

ISO 22882:2004 Ed 1
Castors and wheels - Requirements for castors for hospital beds

BS 4886:1988
Specification for hospital bedsteads

BS 1979:1985
Specification for hospital ward bedsteads for psychiatric hospitals

BS 1694:1990
Specification for hospital ward cots for children

Don't know if this helps.

Steve
 
M

milagre

#3
Thanks Steve. I am not sure which of those standards will apply for us in the end, but it is at least something to go on at the start. I appreciate your help.

:thanks:
 
#4
I would suggest that 60601-2-52 is a very good place to start even if your product is not electrical. Just skip the bits that relate to electrical requirements. The standard has many requirements of mechanical strength and requirements for the avoidance of entrapment.

From the preview available on the IEC web-site it does not explicitly include paediatric beds, but neither does it exclude such beds so I would expect that they are included, so there would be particular requirements included.
 
M

milagre

#5
Pads38,

I thought it would be fair to use the same rational to assume paediatric beds are included by the standard.

My initial thought was to do as you suggest, but I was unsure of myself following a standard that was clearly indicated for electrical equipment. Not that the mechanical parts wouldn't apply - I just felt like I was missing some obvious, similarly all-encompassing standard for non-electrical medical equipment.

However, since I haven't found any such standard, and no one here seems to know of one (yet), I am guessing that there is no such standard. In that case, I think the most appropriate thing to do would be to follow your advice as well as incorporating any other applicable standards (like the castors/wheels standards Steve pointed out).

Thanks for your help.
 

Marcelo

Inactive Registered Visitor
#6
The original standard for non-electrical beds was EN 1970 (Adjustable beds for DISABLED PERSONS – requirements and test methods).

IEC 60601-2-52 merged both IEC 60601-2-38 (Particular requirements for the safety of electrically-operated hospital beds), and EN 1970 (Adjustable beds for DISABLED PERSONS – requirements and test methods).

So IEC 60601-2-52 is applicable to non-electrical medical beds too, although it?s not clear on the title because it?s on the 60601 series.
 
M

milagre

#7
Oh great insight Marcelo. Thanks very much. I will definitely look into IEC 60601-2-52 then.
 
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