IEC 62366 Test Report Form

tazer

Involved In Discussions
:bigwave: 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

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


Envoyé de mon iPhone en utilisant Tapatalk Pro
 

tazer

Involved In Discussions
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

Diapason Consulting
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

Inactive Registered Visitor
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.
 
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Marcelo

Inactive Registered Visitor
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

Involved In Discussions
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"
 
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