IEC 62366 Test Report Form

[tazer]

Hi all,
I'm very glad to converse here again after a moment passed out of medical devices develpment.

To ensure that the 60601 V3.1 is respected, I need to check 62366 too. For this I look for a test report form as the one exists for the 60601 and 62304.
Did you know where I can get it, I have take a look in IECEE web site without succes.
Many thanks.

 

[Vitalix]

Hi Tazer, since you've mentioned that, where can I get the trf for 62304?


Envoyé de mon iPhone en utilisant Tapatalk Pro

 

[Pads38]

where can I get the trf for 62304?

https://webstore.iec.ch/publication/8791

There does not seem to be a TRF for 62366, but there is one for 60601-1-6

https://webstore.iec.ch/publication/8225

 

[tazer]

Resolved.
A collegue has bought it from IECEE, he does not remember where.
The title is : TEST REPORT IEC 62366 Medical devices – Application of usability engineering to medical devices
It is for the 2007 version.
Thanks to all.

 

[marmotte]

I just bought 62366-1:2015 and I don't have :2007

A/ Is it a big risk to build my usability file based on this newer one even though it is not yet harmonized? (our product was CE-marked and released years ago so I'm plugging holes in the documentation rather than building an application)

B/
2015 sounds weird to me :

4.1.2 * RISK CONTROL as it relates to USER INTERFACE design
To reduce use-related RISK, the MANUFACTURER shall use one or more of the following options, in the priority listed (as required by ISO 14971:2007, 6.2):
a) inherent SAFETY by design;
b) protective measures in the MEDICAL DEVICE itself or in the manufacturing PROCESS;
c) information for SAFETY.


This is somehow conflicting with the latest updates to 14971 regarding information for safety which cannot be used as a RCM ???

 

[Marcelo]

This is somehow conflicting with the latest updates to 14971 regarding information for safety which cannot be used as a RCM ???

There's no update to ISO 14971:2007 (yet).

What you are mentioning is related to EN ISO 14971:2012 (which has the weird content deviations), and in fact the content deviation does not preclude using information for safety as a risk control measure anyway.

 

[marmotte]

Isn't EN ISO 14971:2012. harmonized?

 

[Ronen E]

Isn't EN ISO 14971:2012. harmonized?

Yes. I believe that Marcelo was referring to EN ISO 14971:2012 (a typo).

 

[Marcelo]

I believe that Marcelo was referring to EN ISO 14971:2012 (a typo).

Yes, thanks.

It's harmonized to the Eu directives. It's not an international standard.

 

[tazer]

In the french version of the NF EN 14971 of 05/01/2013: It is writen:
"La Norme européenne EN ISO 14971:2012 a le statut d'une norme française et
reproduit intégralement la Norme internationale ISO 14971:2007."

This means : "The EN ISO 14971: 2012 has the status of a French standard and Reproduces in full the ISO 14971: 2007"