IEC 62366-1:2015 Usability Verification / Validation Plan example wanted

mvroops

Starting to get Involved
#1
Hi All,

I would like to prepare usability verification and validation plan for ISO 62336.

Anybody having sample template for the same?
if kindly share
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#3
Usability is so specific to the item being examined, I don't think a generic template would be possible.

The standard calls for (one or more) formative studies. Each formative study could be for a different aspect of the UI and they are intended as much for learning as anything. The basics would be to define what what you want to assess, define who you want to be involved, gather data regarding the use / usability of the aspect under the study, and then refine, as necessary, the UI (and update the Risk Analysis if appropriate). The data could be based on user feedback (i.e., usability scores) or from observation (was the user able to do the function).

The summative study is designed to confirm that the use / usability controls are in place to ensure the device is used safely. Depending on the actors involved, this could be multiple studies also. And, as you might guess, a summative study for a tongue depressor would be vastly different from a summative study involving an infusion pump.

If you don't have the standard, you should get it plus IEC TR 62366-2:2016 (the guidance on the application of the standard) plus ANSI/AAMI HE75. Good information in all those about usability / usability engineering (process).
 

tazer

Involved In Discussions
#4
I'm working on this document. I took as a starting point the Annex H of 62366. It gives a good template to begin with.
 
F

fayyaz NDT Level 3

#7
:thanx:
Hi All,

I would like to prepare usability verification and validation plan for ISO 62336.

Anybody having sample template for the same?
if kindly share
Dear Ajit,

I am from line pipe manufacturing organization (pipe mill as per API 5L).We have included design and development in our scope.
we manufacture a range of pipe diameters and these sizes are repeated time to time.does it need to repeat design validation every time or limited to once for any pipe size.
our manufacturing processes are well defined and all process inputs (machine,manpower,parameter range) is same under same product standard (API 5L).

We manufacture pipes under same product specification or even for same client.All the process (NDT,WELDING,HYDROTEST,BEVELING) are qualified and tested for all pipe sizes many times.
do we also need to repeat validation each time.
based on our previously qualified designs,can we continue our regular production after one or two initial pipes are manufactured and tested satisfactorily & we maintain and adjust all parameters for ongoing production.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
:thanx:
Dear Ajit,

I am from line pipe manufacturing organization (pipe mill as per API 5L).We have included design and development in our scope.
we manufacture a range of pipe diameters and these sizes are repeated time to time.does it need to repeat design validation every time or limited to once for any pipe size.
our manufacturing processes are well defined and all process inputs (machine,manpower,parameter range) is same under same product standard (API 5L).

We manufacture pipes under same product specification or even for same client.All the process (NDT,WELDING,HYDROTEST,BEVELING) are qualified and tested for all pipe sizes many times.
do we also need to repeat validation each time.
based on our previously qualified designs,can we continue our regular production after one or two initial pipes are manufactured and tested satisfactorily & we maintain and adjust all parameters for ongoing production.
This thread has a medical devices perspective. Are your products related to medical devices?
 

yodon

Staff member
Super Moderator
#10
Could anyone please give a copy of Annex K of the 62366-2?
Short answer: no; it's copyright material.

As I presume you're aware, it's a discussion on the number of participants ('sample size') in a usability test. The gist is that after 15 participants, likelihood of finding new issues drops significantly.

FDA has a guidance document (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm259760.pdf), "Applying Human Factors and Usability Engineering to Medical Devices" that echoes (see Appendix B) much of what's in Annex K, including the recommendation of 15 study participants.
 
Thread starter Similar threads Forum Replies Date
K Primary Operating Functions (POF) in IEC 62366-1:2015. IEC 62366 - Medical Device Usability Engineering 7
C Usability IEC 62366-1:2015 and MDR 2017/745 - Risk based approach IEC 62366 - Medical Device Usability Engineering 1
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
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
adir88 Amendment 1 of IEC 62366-1 - Details yet? IEC 62366 - Medical Device Usability Engineering 2
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
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
T I need to make test reports according IEC 62304 & IEC 62366 IEC 62366 - Medical Device Usability Engineering 2
T IEC 62366 Test Report Form IEC 62366 - Medical Device Usability Engineering 20
S IEC 62366 - Usability Test Protocol format Imported Legacy Blogs 0
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
T IEC 62304 : Risk control for SaMD IEC 62304 - Medical Device Software Life Cycle Processes 8
G IEC 60601 Compliance IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
W IEC 60601-1 clause 8.8.3 - Dielectric Strength IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
L ISO/IEC 20000-6 Technical Areas IT (Information Technology) Service Management 0
B IEC 60601-1 Clause 14.8 - Architecture IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
T Infusion pump and IEC 62353 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
F IEC 62304 agile development EU Medical Device Regulations 1
R IEC 60601-2-57 light source classification IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
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 5
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

Similar threads

Top Bottom