Use of Exact Text with the Graphical Symbols in User Guides

[sreenu927]

Hi All-

Is it mandatory to have the exact text of symbols in the user guides?

For example - on the label, if we use the the "open book with "i" symbol, and can we use the similar text having the same intent or the exact text from the EN 980 or ISO 15223 as such - "see user documentation" or "consult instructions for use.
And for temperature symbol - "temperature limit" as per the ISO 15223 std or a similar verbiage like "upper and lower limits of temperature" or "range of temperature?

Thanks,
Sreenu

 

[Marc]

A quick "Bump". Feedback appreciated! My Thanks in advance!

 

[J0anne]

See page 3, note 3 of 15223 - (BTW 980 has been withdrawn.)

 

[somashekar]

See page 3, note 3 of 15223 - (BTW 980 has been withdrawn.)

Thanks for telling here what it says ~~~

 

[sreenu927]

Hi J0anne,

Thanks. In between, could you pls share what exactly it was indicated in pg3. Sorry, I think, my subscription was expired with Techstreet and unable to open the std.

Thanks,
Sreenu

 

[pkost]

See page 3, note 3 of 15223 - (BTW 980 has been withdrawn.)

ISO 15223 is not currently a harmonised standard. EN 980 remains current (although due to an administrative error it was removed from the list)

Please see this post: http://elsmar.com/Forums/showpost.php?p=510525&postcount=14

(as part of http://elsmar.com/Forums/showthread.php?t=58227&highlight=15223)

 

[drewsky1]

I have a similar question in regards to ISO15223and the title of the symbol for Do Not Re-use. There is a note (see below) that speaks to synonyms for Do Not Re-use. Is is acceptable to use one of the synonyms such as "Single Use" instead of Do Not Re-use? Currently our labeling has the text "Sngle Use" beside this symbol and we feel it is okay to leave as is and still be compliant to ISO 15223. Does anyone agree/disagree?

5.4.2​

Do not re-use Indicates a medical
device that is
intended for one
use, or for use on a
single patient during
a single procedure.​

NOTE Synonyms for
?Do not re-use? are ?single​

use? and ?use only once?.

 

[sreenu927]

It is fine, if synonyms as indicated in the standard (15223 or 980) are used!

Regards,
Sreenu