IEC 62366:2007 - Is FDA Usability Engineering Standard a Requirement in Canada?

[melaniewalls]

I've been hunting around to try to find out whether this FDA usability engineering standard is a requirement in Canada - can anyone point me in the right direction?
Also, is 14971:2007 a requirement? I'm wondering if 62366 would be bought in by association if so as they are linked.
Mel

 

[Mondo 22]

Mel,

here is a list of standards recognized by Health Canada - http://www.hc-sc.gc.ca/dhp-mps/md-im/standards-normes/md_rec_stand_im_norm_lst-eng.php#a11

It doesnt make reference to IEC62366:2007 but does reference 14971:2009

Regards,
Ray

 

[Pads38]

That list includes CSA C22.2 NO 60601-1 CAN/CSA:2008. Also listed is the Usability collateral standard IEC 60601-1-6:2006. Being collateral means, in effect, that it is a compulsory extension to the base standard.

60601-1-6:2006 is very similar to 62366.
The new version of 60601-1-6:2010 states as a requirement that "a usability engineering process complying with 62366 has been carried out"

It's difficult to escape.

 

[MIREGMGR]

That list includes CSA C22.2 NO 60601-1 CAN/CSA:2008. Also listed is the Usability collateral standard IEC 60601-1-6:2006. Being collateral means, in effect, that it is a compulsory extension to the base standard.

60601-1-6:2006 is very similar to 62366.
The new version of 60601-1-6:2010 states as a requirement that "a usability engineering process complying with 62366 has been carried out".

Importantly, though, this chain of standards in effect only requires usability analysis for devices that are within the scope of IEC60601-1, i.e. medical electrical equipment.

Other device types apparently do not require usability analysis per Health Canada.

 

[Stephen.Robinson]

Health Canada references: IEC 60601-1-6:2010-Ed.3.0
Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability

This version of IEC 60601-1-6 cannot be completed without the use of IEC 62366.

 

[J0anne]

Gone to read 60601