IEC 62366 Test Report Form

tazer

Involved In Discussions
#11
About your question (A):
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)
The version NF EN 62366: 2015 is the French standard and reproduces in full 62366: 2007 + amendment A1: 2014.
The difference with the 2007 and the addition of caluse 5.10 and annex K concerning the UOUP.
 
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Ronen E

Problem Solver
Staff member
Moderator
#12
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"
All EN ISO 14971:2012 derivatives (including the French one) reproduce in full ISO 14971:2007, but they also contain the "Z annexes" which created in that case a lot of confusion.
 
T

Talichek

#13
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.
tazer

i would be VERY glad if you have the possibility to share your copy.
If in any chance you have a test report of 60601-1-6 as well i would ask you my wife to name our next child on your name :)
:bigwave:
 

Al Rosen

Staff member
Super Moderator
#14
tazer

i would be VERY glad if you have the possibility to share your copy.
If in any chance you have a test report of 60601-1-6 as well i would ask you my wife to name our next child on your name :)
:bigwave:
The document is copyrighted and it's against the forum rules to request or share copyrighted material. please do not request or share copyrighted material in the forum.
 

tazer

Involved In Discussions
#15
As Rosen says, I could not. But, for the 60601-3.1 test report, what I can suggest you is look for some CB report on the internet to see how it is
 
B

BhupinderSinghPawa

#18
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 ???
The EN IEC 62366:2008 and 2015 are harmonized standard.

The EU recognizes EN 62366:2008. The FDA recognizes IEC 62366-1:2015.

A general recommendation for 'new product development' is to use latest revision of standards to keep up with state of art and be future proof.

Even though EN ISO 14971 has moved from 2007 revision to 2012 revision, most of the standards still refer to the 2007 revision. Note that EU recognizes EN ISO 14971:2012 for compliance to MDD and FDA recognizes ISO 14971:2007. This is another topic in itself.
 
Last edited:
T

Talichek

#20
Thank you tazer for the help.

The problem that they are for 60601-1 and not suitable..
i'm still looking to find the relevant ones
 
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