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Device Labeling Standards: Is ISO 15223:2000 Replacing EN980?


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  Post Number #1  
Old 16th January 2004, 12:15 PM
RG Ohidy

 
 
Total Posts: 62
Question Device Labeling Standards

I am currently using "EN980-Graphical Symbols for use in the labelling of Medical Devices". Is this standard being phased out and replaced by ISO 15223:2000?
I am going crazy lately with all of these standard changes. I get over one hurdle and am faced with another. Such is life.
Rich

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  Post Number #2  
Old 16th January 2004, 04:39 PM
Aaron Lupo's Avatar
Aaron Lupo

 
 
Total Posts: 908
Re: Device Labelling Standards

Rich-

I would say no, but at this point it is a guess. EN980 is 2003 revision, I know the EU has subtle differences in their labelling techniques. I will see if I can come up with a better response for you.
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  Post Number #3  
Old 18th January 2004, 05:46 AM
wrodnigg's Avatar
wrodnigg

 
 
Total Posts: 254
Re: Device Labelling Standards

The "homepage" for all kinds of CE-marking can be found at the New Approach

There is also a list of the harmonized standards

EN 980 was revised and published last year and is the newest standard for the use of symbols on medical devices and IVDs.
This new document replaces EN 980:1996, EN 980:1996/A1:1999, and EN 980:1996/A2:2001. It also includes new IVD symbols.

ISO 15223:2000 is not listed in the harmonized standards of the EG directives.

And we advice device manufacturers to use the new EN 980 for labelling questions.

p.s. For CE marking you should follow EN 980 (because this is an EN), FDA Recognizes Selected ISO 15223 and EN 980 Medical Device Symbols and has recently issued a Draft on labelling.

pp.s. There is also an EN 1041 "Information supplied by the manufacturer with medical devices "

Last edited by wrodnigg; 19th January 2004 at 06:59 AM.
Thanks to wrodnigg for your informative Post and/or Attachment!
  Post Number #4  
Old 19th January 2004, 02:37 PM
RG Ohidy

 
 
Total Posts: 62
Re: Device Labelling Standards

Thank you very much for the information. I find that I need the latest revision of EN980.
Rich
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