Graphical Symbols - EN 980 - Labeling of Medical Devices and EN 60601-1 Symbols

NhuTuyet

Starting to get Involved
#11
Hi everyone,

You can download the symbols of the EN 980 standards on the TUV website under document download of the medical devices chapter (sorry I can't post url because I haven't posted enough messages).

I have a question : I work for a medical device manufacturer and we are working on the package of our products. Actually we are using the EN 980 standard for the symbols (only the symbols except for the "do not use if the package is damaged" for which we have put the text). Will it be ok for the FDA or does the FDA not recognized those symbols so we have to add all the symbols' texts ?

Thank you for your answer.

NT
 
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M

MIREGMGR

#12
There are various versions of the FDA's current stance, depending on who you ask.

A written guidance says that a limited set of symbols by themselves are acceptable for IVDs for professional use, but not elsewhere. The implication is that symbols are ignored, and the FDA pays attention only to English text.

Some examiners and some DSMICA personnel say that the IVD-guidance symbol set is accepted on all types of professional-use devices without English subtext, but anything for which one of those limited-set symbols is not available must be communicated in English text.

There seems to be general agreement that consumer products must be described using English text.

In any case, the FDA does not recognize EN 980 and ISO 15223 directly, and does not recognize conformance to those standards.
 

NhuTuyet

Starting to get Involved
#13
Thanks for your answer MIREGMGR!!

However, I am confused and i don't understand this part

In any case, the FDA does not recognize EN 980 and ISO 15223 directly, and does not recognize conformance to those standards.
On the FDA website, ISO 15223: 2000 and EN 980: 1996 are recognized standards but for IVDD only.

We sell implants that are not IVDD: Will it be safer for us to put the symbols' texts on the IFU (in english of course)?

Thanks a lot.

Have a nice day.

NT.
 
M

MIREGMGR

#14
On the FDA website, ISO 15223: 2000 and EN 980: 1996 are recognized standards but for IVDD only.
Yes, of course you're right, but note that the symbol acceptability is limited to the defined set of symbols.

You had mentioned that your company makes devices, and I was answering from a device (non-IVD) perspective. Sorry to have been incomplete.

Will it be safer for us to put the symbols' texts on the IFU (in english of course)?
If the IFU is separate, then any content there is--from an FDA perspective--irrelevant to the completeness of the label itself. Symbols on the label (perhaps, depending on your interpretation of the informal stance regarding non-IVD applications of the IVD guidance) must be directly accompanied by equivalent English text.

Be aware of course that single-language text on a label is inconsistent with many other nations' formal labeling expectations. I don't know of any way around that conflict.
 
A

Adele

#15
We were recently asked by the FDA to add English translations next to certain symbols on labelling submitted as part of a 510(k). The symbols included the 'Manufacturer' symbol from EN 980 and the 'Caution' symbol from IEC 60601-1 (3rd ed).

We successfully argued against including English translations. Our main point was that our labels have all FDA-required labelling information and the use of the symbol doesn't detract from that. Additionally, we stated that the IEC 60601-1 symbol was due (at that time) to be recognised by the FDA and that included the symbols.
 
M

MIREGMGR

#16
I don't suppose you'd be willing to post the 510(k) number in question?

That decision might be usable by others as legal precedent.

Among other things, if that precedent were established, it would represent a major strategic FDA position-shift toward harmonization.

Very interesting.
 
N

NickM

#17
Hi everyone,

You can download the symbols of the EN 980 standards on the TUV website under document download of the medical devices chapter (sorry I can't post url because I haven't posted enough messages).

I have a question : I work for a medical device manufacturer and we are working on the package of our products. Actually we are using the EN 980 standard for the symbols (only the symbols except for the "do not use if the package is damaged" for which we have put the text). Will it be ok for the FDA or does the FDA not recognized those symbols so we have to add all the symbols' texts ?

Thank you for your answer.

NT
NhuTuyet,

Which TUV website are you referring to for the EN 980 symbols?
 
S

swtlilangelz

#18
Another option is to purchase BIP 3083:2009 - Graphical symbols for use in the labelling of medical devices CD-ROM. This is essentially a CD with the full text of BS EN 980 and graphic symbols in various useable formats (TIF, JPEG en EPS). Hope this helps!
 
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