Medical Device Requirements - Labels - Embossing, Coloring

dr1vn

Involved In Discussions
#1
Two Questions:

1. Are there any specific requirements for determining if a medical device label can be embossed/debossed? I have read through the 60601-1 standard and noted that in Clause 7.1.2 there is mention of legibility of markings which would mean that embossing/debossing medical device labels into a device enclosure would be fine as long as one is able to read them.

2. Does the reading man in Annex D2, Symbol 10 (Refer to instruction manual/ booklet) have to be blue? Could one use green, black etc?

Thanks!
 
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Mark Meer

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#2
1. Are there any specific requirements for determining if a medical device label can be embossed/debossed? I have read through the 60601-1 standard and noted that in Clause 7.1.2 there is mention of legibility of markings which would mean that embossing/debossing medical device labels into a device enclosure would be fine as long as one is able to read them.
No problem with embossing. Like you say, just make sure it is legible and indelible for the stated lifetime.

2. Does the reading man in Annex D2, Symbol 10 (Refer to instruction manual/ booklet) have to be blue? Could one use green, black etc?
It does have to be blue (unfortunately).
See IEC 60601-1 7.5, Note 2: "The colours for safety signs are specified in ISO 3864-1 and it is important to use the specified colour."
 

Pads38

Trusted Information Resource
#3
As well as the legibility tests of 7.1.2 also consider the effect of multiple cleaning operations (as specified in your Instructions for Use and your expected service life). See clause 11.6.6.
 
N

NickM

#4
If you only have the ability to do black/white, you could consider using symbol ISO 7000-1641 (shown as symbol 11 in table D.1 of 60601-1) instead of ISO 7010-M002. M002 is used when it is a mandatory action to review the accompanying documents, whereas 1641 is more of a recommendation.
 
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