CE Mark Label Symbol Requirements on a Medical Device

[cadevon]

Hello,

My company is pursuing a CE mark on a medical device, and a question has come up regarding how flexible the label and symbol design is while still complying with ISO/CE standards.

Are the symbols specified in documents like 60601-1-8 or 60601-1 exactly what should be used in the design? or is there some flexibility as far as the specifics (color, rounded edges, etc.). We have noticed that other designs for similar products have more attractive symbols used than those specifically stated in the standard.

Thanks!

 

[c.mitch]

Re: Symbol Question for CE Mark

Hi cadevon
Imho this is a non-conformity to modify standardized symbols.
I already had the case with a notified body auditor, who cast an observation about symbols colors not in black.

 

[Marc]

Re: Symbol Question for CE Mark on a Medical Device

Not necessarily specifc to the question, but I found these. I didn't see anything about symbol color, though I only did a quick scan.

Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use

and the attached.
.

 

[J0anne]

Hello,

My company is pursuing a CE mark on a medical device, and a question has come up regarding how flexible the label and symbol design is while still complying with ISO/CE standards.

Are the symbols specified in documents like 60601-1-8 or 60601-1 exactly what should be used in the design? or is there some flexibility as far as the specifics (color, rounded edges, etc.). We have noticed that other designs for similar products have more attractive symbols used than those specifically stated in the standard.

Thanks!

Where colours for safety symbols are specified, they cannot change (60601-1).

The CE Marking dimensions cannot be changed either (93/42/EEC).

Symbols required by 60601-1 shall conform to the requirements in the referenced IEC or ISO publication (7.6.2)