Hi,
Is it acceptable to use 60601-2-2:2017 even if not shown in the OJ?
Regards,
Quinn
Quinn, yes you can use National standards which are not in the OJ, but the standards used should be a) "state of the art" AND
b) complying to harmonized standard as appropriate/applicable for manufacturers listed in official journal as Pads38 previous commentary.
{Ref: EU MDR "recognise the important role of standardisation in the field of medical devices, compliance with harmonised standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (15) should be a means for manufacturers to demonstrate conformity with the general safety and performance requirements and other legal requirements, such as those relating to quality and risk management, laid down in this Regulation."}