Application of IEC 62366 - Usability of Non-Active Medical Devices

Chrisx

Involved In Discussions
#1
Does anyone have any examples they could share on the application of IEC 62366 to a non-active medical device (non-electical). Since the standard was issued by the IEC from a subcommitted focused on electric medical devices, naturally the standard is focused on electrical devices. However, this is the only harmonized standard for usability in the EU and essential requirement #1 requires that I reduce the risk of use error as far as possible.

I know auditors that have written findings that IEC 62366 was not considered for a non-active medical device. Of course the standard is not law, but I must justify the equivalence of any alternative approach that I take.
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
Re: Usability of non-active medical devices

Although IEC 62366 was based on IEC 60601-1-6 (and a lot of the examples com from electrical medical devices), the process in fact is not really focused on electrical, because it?s focused on user interface (which is defined as means by which the user and medical device interact) design. So it?s works for any device, you just need to focus on the device-user interaction.
 

Chrisx

Involved In Discussions
#3
Re: Usability of non-active medical devices

I understand that the standard can be used for any device. However, I see limited value in defining the user interface, frequently used functions, primary operating functions, frequently used functions, usability verification/validation plan of a screwdriver. It is a lot to digest for class I instruments. I was hoping maybe someone would have an example of implementation. I have a few hundred instruments to do this with.
 

Marcelo

Inactive Registered Visitor
#4
There?s a requirement in 4.3 regarding the scale of the usability engineering process. If some of the requirements do not fit your device or are not value-adding, you usually can bypass them with a simple justification. Or you can perform a very, very simple full-process.
 

Sam Lazzara

Trusted Information Resource
#5
Re: Usability of non-active medical devices

Sounds like all of your devices are hand tools, so the hand/tool interface is your user interface. There is a chapter in AAMI HE75 dedicated to hand tools. I have been working with non-active devices (mostly implants) for some time now, and I have a few ideas for you.

My strong recommendation is to NOT to create separate procedures for useability engineering, but to INTEGRATE those concepts/requirements into your existing design control and risk management procedure(s).

This means you may need to update your design control and risk management procedure(s) to reflect the requirements of 62366. You are already doing design verification and design validation - hopefully that meets the requirements for user interface/usability verification and validation. If everything is integrated, your existing Design History File can also serve as your Usability Engineering File.

I do recommend that you hit the Application Specification head-on by adding a section to your existing Design Input specification document with that name. Here is a link to an example.
https://medicaldevicequality.egnyte.com/publicController.do?folderName=20130206&fileName=9e8f4abe794f449f

Regarding the connection between risk management and usability, if you look at the questions to identify safety-related device characteristics in the informative annexes of 14971 (Annex C) and 62366 (Annex E), you will see they are virtually identical.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: Usability of non-active medical devices

I very much concur with Sam, however I have a slight reservation regarding the following phrase:

You are already doing design verification and design validation - hopefully that meets the requirements for user interface/usability verification and validation. If everything is integrated, your existing Design History File can also serve as your Usability Engineering File.
Proper design verification and design validation can in theory meet the requirements for user interface/usability verification and validation, "by chance"; however, from my limited experience, this is seldom the case unless an intentional effort has been made in that direction. Typically, organizations that are not yet fully aware of usability engineering aspects, miss out on thoroughly addressing those aspects, in their design verification and design validation.

Cheers,
Ronen.
 
Q

Quality Julie

#7
I am struggling with this standard for a simple IVD like a home pregnancy test or a professional ELISA kit. Seems like a lot of work when we follow the IVD standards that include user testing for self-testing products. User interface for a common ELISA that is done by a licensed clinical laboratory? Really, they should know how to use a pipette (that we don't supply). Just reagents. For our products that are self-testing, we follow those standards for self-testing which include user studies, etc.

Also, the organization that produced the standard is Cenelec, which is the European Committee for Electrotechnical Standardization. How can an organization for an active medical device develop a standard for an IVD that has no active equipment associated with it. :bonk:

-Julie
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Hi,

Every device has a user interface; otherwise it wouldn't have been able to be used. Some interfaces are simple, other are complex. If the interface is simple and the interaction is straightforward and error-proof, there's no need to ever-complicate things. The intended user population should be factored into any usability study, so if those are professionals it should have an effect on the process and on the results.

The keyword is "Misuse". The device is intended by the manufacturer to be used in a certain way. Using it in ways other than that is (in most cases) misuse. Usability analysis relates to risks associated with misuse, and usability engineering relates to weeding out (or preventing upfront) such risks that are unacceptable. It is a universal approach, and has little to do with any device's specifics. 62366 explains the concepts pretty well, and there are plenty of other resources available.

Cheers,
Ronen.
 
Q

Quality Julie

#9
Thanks Ronen,

I have read the standard cover to cover many times, and quite honestly ditched it and read the FDA guidance document on human factors which was clearer to me - I'm from the US so that might have a bearing.

I was actually seeking practical help from someone who has done this for an IVD. I understand that human factors need to be considered but we comply with standards related to self-testing products which contain clear guidance on how to address human factors. Really mirrored a scaled down version of 62366 and I really didn't want to duplicate efforts. So I just referenced 62366 in our Risk Analysis SOP and made a statement in our design control SOP that our DHF serves as our Usability Engineering File. We'll see if our ISO auditor will buy off on it but it's a rather pathetic standard for a simple IVD designed for someone at the 8th grade level and where every example in 100 pages is for an active device.

Thanks,

-Julie
 
Q

Quality Julie

#10
Ronen,

I have thrown this out to many IVD forums and not one IVD manufacturer claims to be following this standard or can provide a single example of how to apply this specifically to an IVD so I don't think it's a simple thing. Not one consultant in LinkedIn that generally spouts advise (primarily theoretical rhetoric) could address the question. I really don't see that when I stated I have read the standard cover to cover, that your advise to read the standard and it's really easy is sound advise. I was looking for specific examples.
 
Thread starter Similar threads Forum Replies Date
P SOUP anomaly evaluation for MMA (Mobile Medical Application) IEC 62304 clause 7.1.3 IEC 62304 - Medical Device Software Life Cycle Processes 6
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Y Application of IEC/EN 62304 at an advanced stage of software development IEC 62304 - Medical Device Software Life Cycle Processes 4
M Application of IEC 60601.2.2:1999 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
Hershal PAC (Pacific Accreditation Cooperation) guidance on application of ISO/IEC 27000 IEC 27001 - Information Security Management Systems (ISMS) 0
L When IEC 60601-1 2nd edition can not be used for CE mark medical device application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Marc ISO/IEC 90003:2004 Software Engineering - Guidelines - Application of ISO 9001:2000 Other ISO and International Standards and European Regulations 6
shimonv Where do you place Human Factors report in a 510(k) application? Other US Medical Device Regulations 3
Jessesun The application of ozone sterilization in medical treatment US Food and Drug Administration (FDA) 0
L API Q1 Application Oil and Gas Industry Standards and Regulations 2
I Software (SaMD) mobile application verification testing: objective evidence Medical Information Technology, Medical Software and Health Informatics 2
D Dental application - medical product or not? Other US Medical Device Regulations 8
T Including a class 1 camera in the 510k application of class 2 therapeutic technology? US Food and Drug Administration (FDA) 18
shimonv Can you submit a traditional application for a class I device? Other US Medical Device Regulations 7
A Should we assign the PRRC before the date of application of MDR (26 May 2021)? EU Medical Device Regulations 0
T Google Fit Health datas and Medical devices Application Medical Information Technology, Medical Software and Health Informatics 2
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
lanley liao Are there guidelines for application of all API monogrammal product? Oil and Gas Industry Standards and Regulations 2
G Application to Chartered Quality Institute - MCQI ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
supadrai Possible to Submit a 510(k) if you have never, do not and cannot produce the device for which you're submitting the application? US Food and Drug Administration (FDA) 4
M Surgical angle measurement guide device with an application software Medical Device and FDA Regulations and Standards News 4
Sidney Vianna IATF 16949 News Update on the IATF CARA Project (“Common Audit Report Application”) - 12/2020 IATF 16949 - Automotive Quality Systems Standard 1
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
U GMDN CODES application ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Monolithic application and medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
R CAMBODIA - Application of AMDD Other Medical Device Regulations World-Wide 3
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
C New Class III medical device application for Health Canada Canada Medical Device Regulations 6
T Commission proposal being drawn up for postponement for date of application of MDR (2017/745) EU Medical Device Regulations 7
N Program or application for standard time measurement in industry from video surveillance? Human Factors and Ergonomics in Engineering 1
J Are DAM tools, Mobile application, clinical dashboard, etc. considered accessories to medical device or supportive functions? Manufacturing and Related Processes 4
J Application of mains voltage on SIP/SOP connectors of medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L External power supplies: How close does the safety report have to match the end-use application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Informational TGA presentation: How to submit an effective good manufacturing practice clearance application Medical Device and FDA Regulations and Standards News 0
C ISO 9001:2015 Monitoring and measuring resources. Application a service industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Z Role of economic operators (EO) post the EU MDR Date of application in May 2020 EU Medical Device Regulations 1
M Informational EU – Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC Medical Device and FDA Regulations and Standards News 2
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
A Validating my own application developed with Agile Qualification and Validation (including 21 CFR Part 11) 5
M Informational EU – Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council o Medical Device and FDA Regulations and Standards News 2
Sidney Vianna Informational ISO 18091 - Guidelines for the application of ISO 9001 in local government Other ISO and International Standards and European Regulations 1
S Internal Audit Checklist for Application/Software development IEC 27001 - Information Security Management Systems (ISMS) 1
M Informational MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017 Medical Device and FDA Regulations and Standards News 0
D I'm new in IMDS special using the IMDS application Manufacturing and Related Processes 8
M Medical Device News NB-Med and Team-NB have jointly edited a white paper entitled “White Paper – One Year of Application” Medical Device and FDA Regulations and Standards News 0
S IATF 16949 9.1.1.3 Application of statistical concepts - Our technicians are quizzed for statistical knowledge IATF 16949 - Automotive Quality Systems Standard 3
supadrai Informational Japan Minor Change Notification Application Form - Found it? Japan Medical Device Regulations 0
M Some possible misunderstandings on the application of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 10
K Need feedback: FMEA Web Application FMEA and Control Plans 5
I FAR Part 43 and Application to 17025 Accredited Cal Lab Federal Aviation Administration (FAA) Standards and Requirements 2

Similar threads

Top Bottom