SBS - The Best Value in QMS software

IEC 62366 Test Report Form

tazer

Involved In Discussions
#1
: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.
 
Elsmar Forum Sponsor

tazer

Involved In Discussions
#4
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

Involved In Discussions
#5
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
#6
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.
 
Last edited:

tazer

Involved In Discussions
#10
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"
 
Thread starter Similar threads Forum Replies Date
T I need to make test reports according IEC 62304 & IEC 62366 IEC 62366 - Medical Device Usability Engineering 2
S IEC 62366 - Usability Test Protocol format Imported Legacy Blogs 0
adir88 Amendment 1 of IEC 62366-1 - Details yet? IEC 62366 - Medical Device Usability Engineering 2
K Primary Operating Functions (POF) in IEC 62366-1:2015. IEC 62366 - Medical Device Usability Engineering 7
V Applicability of IEC 62366-1 usability to resorbable bone substitutes IEC 62366 - Medical Device Usability Engineering 9
pashah Looking for Usability File Template acc. IEC 62366-1 and IEC 60601-1-6 IEC 62366 - Medical Device Usability Engineering 4
C Usability IEC 62366-1:2015 and MDR 2017/745 - Risk based approach IEC 62366 - Medical Device Usability Engineering 1
E Usability Process - Looking for a template (IEC 62366) IEC 62366 - Medical Device Usability Engineering 1
J IEC 62366 - Ethical approval IEC 62366 - Medical Device Usability Engineering 5
J IEC 62366 - Summative Evaluation IEC 62366 - Medical Device Usability Engineering 6
C IEC 60601-1-6 2010 maps to IEC 62366:2007 - What about 62366-1:2015? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
K Usability of ME Equipment - IEC-62366-1:2015 IEC 62366 - Medical Device Usability Engineering 3
M IEC 62366-1:2015 Usability Verification / Validation Plan example wanted IEC 62366 - Medical Device Usability Engineering 20
T IEC 62366:2015 Annex C - changed parts from 5.1-5.8 --> but what about 5.9? IEC 62366 - Medical Device Usability Engineering 3
M IEC 62366-1 published - March 2015 IEC 62366 - Medical Device Usability Engineering 7
S IEC 62366 vs. FDA Human Factors Requirements Human Factors and Ergonomics in Engineering 2
Z Final Validation Unit Requirements - Annex D of IEC 62366 IEC 62366 - Medical Device Usability Engineering 6
Z IEC 62366 and Medical Device Usability Validation IEC 62366 - Medical Device Usability Engineering 10
C Application of IEC 62366 - Usability of Non-Active Medical Devices IEC 62366 - Medical Device Usability Engineering 15
T IEC 62366 included in 3rd ed IEC 60601? IEC 62366 - Medical Device Usability Engineering 1
M IEC 62366:2007 - Is FDA Usability Engineering Standard a Requirement in Canada? Canada Medical Device Regulations 5
S IEC 62366 - Embedded Software in separate Usability Engineering File? IEC 62366 - Medical Device Usability Engineering 1
J Where to buy standards such as IEC 62366:2007 Other Medical Device Related Standards 2
S IEC 62366 for Stand-Alone Medical Device Software and Usability Engineering IEC 62366 - Medical Device Usability Engineering 16
D Training on IEC 62366 (Medical Device Usability Engineering) for CE Mark? IEC 62366 - Medical Device Usability Engineering 5
M What do you think the revision of IEC 62366 should bring? IEC 62366 - Medical Device Usability Engineering 16
A IEC 60601-1-6 last release or IEC 62366? IEC 62366 - Medical Device Usability Engineering 17
K How to apply IEC 62366 and what shall be changed in establishing a Technical File ISO 13485:2016 - Medical Device Quality Management Systems 2
D IEC EN 62366 Usability Retroactive Compliance Other Medical Device Related Standards 1
R ISO IEC EN 62366 Usability Engineering Essential Requirements IEC 62366 - Medical Device Usability Engineering 8
P IEC 62366 vs. IEC 60601-1-6 - Has IEC 62366 now replaced IEC 60601-1-6? IEC 62366 - Medical Device Usability Engineering 19
shimonv Working with a software developer who is not setup for IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
P Examples of quality plans in IEC 62304 US Food and Drug Administration (FDA) 2
L Top opening of enclsoure against fire in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S ISO/IEC 15408 - Is this is Certifiable Standard? Other ISO and International Standards and European Regulations 2
C EN 45502 vs IEC 60601-1-8 Other Medical Device Related Standards 0
Richard Regalado Informational ISO/IEC DIS 27001:2021, to be published soon. IEC 27001 - Information Security Management Systems (ISMS) 0
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
B 3-phase supply, overvoltage catogory, line-to-neutral and working voltage (IEC 61010-1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B European Harmonized vs IEC standard IEC 62366 - Medical Device Usability Engineering 2
E Software maintenance Process Software maintenance Process to IEC 6204? IEC 62304 - Medical Device Software Life Cycle Processes 3
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
JoCam IEC 60601-1 and 60601-1-2 retest after PCBA change IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K IEC 60601-1:2005/AMD2:2020, Why this standard version is 3.0? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B Reference to IEC 60950-1 in Amendment 2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C IEC 60601 - 8.8.3 Dielectric Strength test. 4kv being applied to the ground conductor?! IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 Clause 15.3.2, Push test IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5

Similar threads

Top Bottom