IEC 60601-2-2:2017 Compliance Dates

[katastic2908]

Good Morning,

I have tried to find this on my own but not having any luck. Can anyone tell me for both US and EU what the transition period is for 60601-2-2:2017?

Both this revision and the previous revision are on the FDA's list of recognized standards, but I couldn't find anything else.

TIA

 

[Pads38]

That version of the standard (high frequency surgical equipment) is not yet shown on the Official Journal of the EU. The one shown is the 2009 edition.

See here:
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=uriserv:OJ.C_.2017.389.01.0029.01.ENG

That is a link to the OJ which is the official record of the currently recognised standards. The link is to the November 2017 OJ.

The OJ is irregularly published, perhaps every 9 months or so.

Once a new version of a standard is listed in the OJ there tends to be around 2 years before the previous version ceases to be recognised (DOCOPOCOSS !).

 

[QuinnM]

Hi,

Is it acceptable to use 60601-2-2:2017 even if not shown in the OJ?

Regards,
Quinn

 

[QAengineer13]

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."}