Non-sterile - Does anyone know of a universal symbol?

B

Bridget

#1
Hello Cove Folks,
Does anyone know of a universal symbol that signifies "Non-Sterile"? I have not purchased the new version of EN 980 because the last time I paid for a new version the only change was to one sentence, no new symbols! I am not asking for the symbol but can anyone tell me where I can find it so I don't waste money purchasing a document I don't need.
Thanks,
Bridget
 
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Wes Bucey

Quite Involved in Discussions
#2
Bridget said:
Hello Cove Folks,
Does anyone know of a universal symbol that signifies "Non-Sterile"? I have not purchased the new version of EN 980 because the last time I paid for a new version the only change was to one sentence, no new symbols! I am not asking for the symbol but can anyone tell me where I can find it so I don't waste money purchasing a document I don't need.
Thanks,
Bridget
You want ANSI/AAMI/ISO 15223:2000/A1:2001
You can find it here:
http://marketplace.aami.org/eseries/scriptcontent/docs/15223a0111.pdf
The symbol is a triangle with the English NON STERILE in all caps.
The triangle is usually an alert symbol with a mark or symbol inside. Typical is a triangle with just an exclamation mark (!) inside, which alerts the reader to look elsewhere on the label for an explanation. In the case of a "nonsterile" alert, labels usually give instructions for sterilization procedure prior to use.

If ISO or European Union has come out with a different symbol, I haven't seen or heard of it, yet. Anyone with more info? more recent info?
 
W

wrodnigg

#3
In Europe the actual harmonized standard for "Graphical symbols for use in the labelling of medical devices" is EN 980:2003 (ISO 15223 is not a harmonized standard with the EC directives). Although many symbols are referenced to ISO 15223.

(btw, you can get Amd2 :2004 (two more symbols) here and Amd1:2004 at AAMI)

In EN 980:2003 there is no symbol meaning "non sterile".

p.s.: There is a FDA Draft Guidance for the use of symbols.
 
Last edited by a moderator:
B

Bridget

#4
Example located

Thanks Wes and Wrodnig:

I have located an example of the non sterile symbol on one of our suppliers labeling. Thanks for your help.
Bridget :thanks:
 
B

Bridget

#6
Thanks for the link

Thanks Al, the link was very helpful and now I know I do not need to purchase a new 980 yet. None of the new symbols are needed by us.
Bridget
 
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