Labeling Placement Requirements according to the 60601-1

muhammad sadiq

Starting to get Involved
#1
Hi, so we are working on a medical device(home healthcare device) that is potable(not transit operable), we have made the labels for it according to the 60601-1(clause 7) requirements it contains information like warning signs eg keep dry - information regarding the input power eg 220 VAC , Serial number, manufactures information.

you can make a single label that contains all this info or you can divide this label into one sticker that contains the Serial number lot number and a second sticker that has all other info ie warning signs, input voltages etc

So now my question is related to the placement of this sticker, in clause 7 of 60601-1 the legibility of labels is covered in which it defines when the labels should be visible to the user.

I need some clarity on this clause, again our device is portable + used in home health care + clinics as well, can I put the said label/sticker at the bottom of the machine, it will not be visible to the user until he picks up the machine, the normal use condition of the machine is when its placed straight on the table (hiding the stickers underneath), for reference the machine weighs around to 17 Kgs.

Or the sticker needs to be at the back of the machine clearly visible to the user (this for us will require a redesign of the enclosure).
if the above option is true then can I put the serial number part of the label underneath the machine while keeping the warnings and input voltages label on he back(in order to make it smaller)

thank you in advance.
 
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Peter Selvey

Leader
Super Moderator
#2
The applicable clause/requirement is 7.1.2, 3rd dash. This references "turning" the equipment, so strictly speaking it could be on the bottom.

I personally think it's good to have the mains related information near the power cord exit/appliance inlet, which is often at the back of the equipment, that is not specified in the standard but it makes it easy for the user to locate. Especially if the equipment is 17kg, you don't want to be rotating around trying to find the label.

Note that warnings should be visible from the position of normal use. This is different to ratings. So it is important to take care about what is really a "warning". The symbols used for 7.2.3 (read the IFU) are not usually treated as warnings.
 
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