Profile

Katarzyna Chrusciel

Contact Details

Italy

Contributions

1 to 5 of 50+ total

RE: Availability of ISO 15223 Symbols

Posted By Katarzyna Chrusciel 06-Jul-2023 11:21
Found In Egroup: Regulatory Open Forum \ view thread
Hi Here is the link https://www.iso.org/obp/ui/#home Select graphical symbols. K --------------------------------- Katarzyna Chrusciel ---------------------------------

RE: GSPR 12.2 of MDR

Posted By Katarzyna Chrusciel 03-Jul-2023 14:36
Found In Egroup: Regulatory Open Forum \ view thread
Thank you Richard! Yes, we have already prepared the BEP based on EN ISO 10993-1 and started to perform the tests. I will send the request to the NB if this will be acceptable for them. I will share their feedback. Kate --------------------------------- Katarzyna Chrusciel ------------------- ...

RE: Country of Origin Label

Posted By Katarzyna Chrusciel 02-Jul-2023 03:38
Found In Library: Regulatory Open Forum

RE: Country of Origin Label

Posted By Katarzyna Chrusciel 02-Jul-2023 03:38
Found In Egroup: Regulatory Open Forum \ view thread
Hi EMI, you can also be interested in use of harmonized symbol 5.1.11 (EN ISO 15223-1).  Kate ------------------------------ Katarzyna Chrusciel ------------------------------

GSPR 12.2 of MDR

Posted By Katarzyna Chrusciel 01-Jul-2023 14:16
Found In Egroup: Regulatory Open Forum \ view thread
Hello everyone. I have a question related to the general safety and performance requirement GSPR 12.2 of MDR. This is new requirement related to the devices composed of substances absorbed or locally dispersed (e.g. fillers). These devices must to comply with relevant requirements of Annex I to the ...