IVDD - Software and Graphics Standards or Guidance Documents

[ISO 13485 - Medical]

does anybody know of standards or guidance documents that I can use for and IVDD product and what symbols can be used with regards to graphics on the interface?

thanks in advance

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

[yodon]

I'm not a regulatory expert but I'll toss in my $0.02 to maybe get the ball rolling.

Kind of struggling with how to reply - it's a very open-ended question with a lot of factors to consider that are not communicated in the post. Always a good idea to go to the source, see especially sections 8.4 - 8.7 (I presume this is applicable):

http://eur-lex.europa.eu/LexUriServ/...8L0079:EN:HTML

Maybe more info or more specific questions on particular labels / labeling would get more feedback.

[sreenu927]

Hi
Below is the link to obtain the list of applicable harmonized standards for IVD products.
http://eur-lex.europa.eu/LexUriServ/...31:0034:EN:PDF

Related to labeling, apart from EN 980, EN 18113, ISO 15223 is also a good source to refer.

For "graphics on interface" what exactly you are referring? Just on the flash screen to show it as an IVD? If so, IVD symbol is sufficient.

Regards,
Sreenu