Symbol for manufacturing date - Is ISO 980 expired?

[Jonas Wistrand]

Hi all,

Does anyone know the symbol to use for stating what year the device was manufactured. Someone told me ISO 980 is expired.

Regards,
Jonas

 

[SteveK]

Re: Symbol for manufacturing date

Hi all,

Does anyone know the symbol to use for stating what year the device was manufactured. Someone told me ISO 980 is expired.

Regards,
Jonas

Hi Jonas,

In the repacement standard (ISO 15233-1, ref. 5.1.3) it is exactly the same as in ISO 980 i.e. the factory symbol (unshaded).

Steve

 

[Jonas Wistrand]

Re: Symbol for manufacturing date

OK thanks a lot Steve!

 

[SteveK]

Additional

Found this freely available on the 'net (for anyone unsure what the 'factory symbol' is) - so should not be a copyright issue.

Steve

 

[Lucasmf]

I also highly recommend ISO Online Browsing Platform for all ISO symbols. You can search and get pretty decent images of just about any symbol.

 

[J0anne]

On 31st january 2013 EN 980:2008 will be replaced with EN ISO 15223-1

This is expected to be harmonised under all EU medical device directives

 

[Jonas Wistrand]

Lucasmf and JOanne, thanks a lot for your replies. The Online Platform was great. I searched 15223 and got lots of search results. Symbols that are referenced by the specific standard.

The only downside with the platform is that there is no easy way to buy the symbols in high definition. "Purchase" links you to an e-mail.

Regards,
Jonas

 

[J0anne]

You can get the high definition symbols if you purchase 980.
It comes with a symbol library in three different graphic formats.
Jpg, bitmap and tiff if I remember rightly.

 

[ElisaS]

Hi

Can anyone tell if there is an intl symbol and what symbol should be used for "Manufactured For". We are a contract manufacturer.

Thanks!

 

[wrodnigg]

It is a bit a tricky situation with EN 980.

Theoretically EN 980 is still the MDD and IVDD harmonized standard for medical device symbols.

Unfortunately the harmonization process stopped over one year ago and therefore no new list of harmonized standards has been published in the EU gazette since then.

EN ISO 15223-1 was designated to replace EN 980, but there were some "flaws", so it has not been harmonized (and therefore did not appear in the last published list of harmonized standards Gazette 2013/C 22/02 published 24.1.2013).

And it was some kind of "editorial mistake" that EN 980 disappeared from this list:

For every superseded standard, the new standard is bublished togehter with the date of cessation of presumption of conformity of the superseded standard.
Since this information has not been published for the EN 980 standard so far, it can not have been superseded by any other standard.

Unfortunately EN 980 was declared as withdrawn without harmonization of the sucessor...

But don't worry, just use EN 980 or EN ISO 15223-1, both will work fine.