Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU?

bolesen

Starting to get Involved
#1
We are in process of getting our CE Mark and went through a MDD gap audit and received a non-conformity for our label.

Since a physical label cannot be provided for this software, we need to provide all these required elements along with their corresponding and appropriate symbols:
• Manufacturer's name and address;
• EC-Rep name and address;
• Software version number;
• CE mark.
Also since we note there are a number of precautions and warnings mentioned in the IFU, it would be preferable to also add the IFU symbol and the caution symbol.
And it was noted that all symbols shall be taken from EN ISO 15223-1:2016.

If I purchase EN ISO 15223-1:2016, does this include all the graphic symbols that I can add to our software someplace?
 
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Jean_B

Trusted Information Resource
#3
Note of caution: representations of the symbols are of a resolution allowing adequate reproduction, but they are not in a graphics format which can immediately be used within designs.
 

Pads38

Trusted Information Resource
#4
Note of caution: representations of the symbols are of a resolution allowing adequate reproduction, but they are not in a graphics format which can immediately be used within designs.
That is true. But it does also give the ISO 7000 reference number. Using that online database allows download of the symbols in several graphic formats - at extra cost.
 

bolesen

Starting to get Involved
#5
Yes 15223 does contain all the symbols to use, along with examples and also 'how not to do it' information.

Example A.15 shows how the 'Instructions for Use' symbol can be used alongside an indicator of where to find electronic IfU (could be a web site etc).

Get a multi user license copy for about 20 euro here:

EVS-EN ISO 15223-1:2016 - Estonian Centre for Standardisation
I am wanting the EN ISO 15223-1:2016 in pdf format so I can attach it and reference it in our QMS system.
I just want to make sure the link you sent me will give me access to the full ISO reg document and allow me to download as PDF and attach to QMS.

Thanks,
 

Pads38

Trusted Information Resource
#6
Yes it will.
The multi user licence is an plain pdf, with the licence holder identified with marking in the margin.
(The single user licence requires a separate 'app' to open and is only a few euro cheaper).
 

bolesen

Starting to get Involved
#7
Yes it will.
The multi user licence is an plain pdf, with the licence holder identified with marking in the margin.
(The single user licence requires a separate 'app' to open and is only a few euro cheaper).
Thanks for you quick response's.
Just out of curiosity how do the sell this ISO doc so much cheaper than here in the states? Just want to confirm this will be the official ISO 15223-1:2016 document before purchasing.
Sorry for all the questions I am new to MDD/MDR regulations and a little overwhelmed with CE Mark process to market our software in EU.

Also does EVS offer the different formatted graphical symbols to be downloaded that Jean-B references above?That is true. But it does also give the ISO 7000 reference number. Using that online database allows download of the symbols in several graphic formats - at extra cost.
 

Pads38

Trusted Information Resource
#8
I believe that Standards Estonia makes their standards available at low cost to help and boost their own country's manufacturers and business. Some of the other Baltic states do likewise - its just that the EVS site is very easy to use.

EVS do not publish all standards; typically Technical Report (TR) standards are not 'converted' to EVS standards.
As Estonia is a EU member and the standards being published are 'EN' standards you can be sure that they are identical to all other EN standards (official European standards) except for an Estonian language foreword.

EVS do not do ISO 7000. It is available here:

https://www.iso.org/obp/ui/#iso:pub:PUB400001:en

You can purchase a yearly subscription to the entire database, or click on the symbol you want (using that reference number from 15223) and purchase a download in grahics formats (AI, DWG, EPS).
Personally, I just draw them myself.
 

bolesen

Starting to get Involved
#9
I believe that Standards Estonia makes their standards available at low cost to help and boost their own country's manufacturers and business. Some of the other Baltic states do likewise - its just that the EVS site is very easy to use.

EVS do not publish all standards; typically Technical Report (TR) standards are not 'converted' to EVS standards.
As Estonia is a EU member and the standards being published are 'EN' standards you can be sure that they are identical to all other EN standards (official European standards) except for an Estonian language foreword.

EVS do not do ISO 7000. It is available here:

https://www.iso.org/obp/ui/#iso:pub:PUB400001:en

You can purchase a yearly subscription to the entire database, or click on the symbol you want (using that reference number from 15223) and purchase a download in grahics formats (AI, DWG, EPS).
Personally, I just draw them myself.
Interesting. So, It is not a requirement to be complaint to use the actual downloaded symbol from ISO?
 

Jean_B

Trusted Information Resource
#10
Correct. There is no licensing obligation. Merely requirements to the appropriate use and depiction of the symbols, found in the standard(s).
 
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