SBS - The best value in QMS software

Question: Do we consider 60601-1-2 (4th ed) EMC testing a mode for a diagnostic port?

T

titanius

#1
Hello Everyone, i have a question.

We have this handheld device (class II) that is powered by an alkaline battery for a 510k. It also has a USB port that is strictly for offline downloading of data by connecting to a computer (and in no way can be used to charge the device) and at that time the main device screen (that shows vital) is disabled.

With regards to 60601-1-2 (4th ed) & 510k, what should be the possible test modes:
1. An internally powered handheld device - we already considered and it passed 60601-1-2.
2. Do we have to EMC test the data downloading through the USB as a separate mode?
OR
Can we argue (for not doing this is) that the port is strictly for offline data transfer and put cautions/warnings in the instructions instructing users (along with risk analysis,etc)? And if the user does it anyways and connects to a USB charger/computer it shows a screen to disconnect USB (and disables showing the current vital values). Will that be sufficient?

Thank you for reading ! Any insights are most appreciated!
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Re: Question: Do we consider 60601-1-2 (4th ed) EMC testing a mode for a diagnostic p

Due to Good Friday and Easter Sunday holidays, you may find some delay in response. Please wait, till some 60601 experts here will come up with a response....
Thanks for joining Elsmar and WELCOME to the Cove.
 

shimonv

Trusted Information Resource
#3
Re: Question: Do we consider 60601-1-2 (4th ed) EMC testing a mode for a diagnostic p

Hello Everyone, i have a question.

We have this handheld device (class II) that is powered by an alkaline battery for a 510k. It also has a USB port that is strictly for offline downloading of data by connecting to a computer (and in no way can be used to charge the device) and at that time the main device screen (that shows vital) is disabled.

With regards to 60601-1-2 (4th ed) & 510k, what should be the possible test modes:
1. An internally powered handheld device - we already considered and it passed 60601-1-2.
2. Do we have to EMC test the data downloading through the USB as a separate mode?
OR
Can we argue (for not doing this is) that the port is strictly for offline data transfer and put cautions/warnings in the instructions instructing users (along with risk analysis,etc)? And if the user does it anyways and connects to a USB charger/computer it shows a screen to disconnect USB (and disables showing the current vital values). Will that be sufficient?

Thank you for reading ! Any insights are most appreciated!
Hi titanius,
I am not an expert on EMC test but this is my two cents worth:
Your argument plus risk analysis plus mitigation makes sense providing that the offline download does not occur in the patient environment. I don't know what the workflow is but if you are near the patient while downloading you should - in concept - check for immunity and interference.

-Shimon
 
M

MedMartin

#4
Re: Question: Do we consider 60601-1-2 (4th ed) EMC testing a mode for a diagnostic p

Hi Titanius,

best is to talk to your test house for their opinion.

For the designs I was involved we tried to test all modes of the devices.
One design was very similar to yours, a handheld and no measurement while USB connected. We tested also in the USB communication mode as we considered the data transfer critical for immunity. And emission testing is also necessary.

The 4th edition of the 60601-1-2 also recommends testing e.g. in standby modes which would also support testing USB communication mode.

Best regards
Martin
 

VinceTech

Involved In Discussions
#5
Re: Question: Do we consider 60601-1-2 (4th ed) EMC testing a mode for a diagnostic p

Hi,

If the USB is not restricted to be used by operator or patient, it's SIP/SOP. Then EMC test shall include it. If USB is restricted only to be used for engineering 'for example, for development or factory use', it maybe exempt from EMC test.

Regards,
 
T

titanius

#6
Re: Question: Do we consider 60601-1-2 (4th ed) EMC testing a mode for a diagnostic p

Thank you VinceTech, MedMartin, shimonv, somashekar!

:thanx: so much! this helps a lot.

Your arguments totally make sense. The test house didn't recommend data download mode due to the 'development nature' of the connection.Maybe I might need to rethink about this.
 
Thread starter Similar threads Forum Replies Date
D Work Instruction Question ISO 13485:2016 - Medical Device Quality Management Systems 5
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
John C. Abnet VDA 6.3 - Question 7.3 - "blocking of parts" VDA Standards - Germany's Automotive Standards 4
D Approved supplier list - Distributors question ISO 13485:2016 - Medical Device Quality Management Systems 6
D Equipment Register and PM question ISO 13485:2016 - Medical Device Quality Management Systems 2
D Question regarding "storage and distribution" ISO 13485:2016 - Medical Device Quality Management Systems 1
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 1
D Question regarding customer feedback process ISO 13485:2016 - Medical Device Quality Management Systems 3
A Quality engineering positions in US - question Job Openings, Consulting and Employment Opportunities 1
D Equipment Register related question ISO 13485:2016 - Medical Device Quality Management Systems 1
S Study sign off question / responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 3
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 2
M Question for Auditors - "Off the Record" Conversation? General Auditing Discussions 14
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
A Question on Authorized Representative in Malaysia Other Medical Device Regulations World-Wide 3
D Limited Scope for second site Question? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
Anonymous16-2 Labeling Question (Dietary Supplements/Food) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
T Question for: Cg & Cgk calculation General Measurement Device and Calibration Topics 3
N ASL Question for GitHub ISO 13485:2016 - Medical Device Quality Management Systems 6
hogheavenfarm GDT Flatness measurement question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 11
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Another DFAR question 252.225-7009 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
F Conflict Mineral Smelter Question RoHS, REACH, ELV, IMDS and Restricted Substances 8
R NRTL - Scope Question - Off-the-Shelf Plug In IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D API 6A Certification Question Oil and Gas Industry Standards and Regulations 4
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
R DHR question: Traceability of components ISO 13485:2016 - Medical Device Quality Management Systems 2
C MDR - Question around software accesories EU Medical Device Regulations 2
K My question is, what/when is a nonconformity? Therefore what requires an NCR? Nonconformance and Corrective Action 9
Watchcat Authoritative References about the Research Question? Quality Tools, Improvement and Analysis 0
T Question about Quality Department employee position titles Quality Manager and Management Related Issues 10
N Question on creepage/clearance requirements for HF Active Accessories for 2nd edition 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
J Question: How to create an IMDS RoHS, REACH, ELV, IMDS and Restricted Substances 3
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
B QMS question in regards to multiple medical devices/products and N/A activities Other Medical Device Related Standards 12
C NB approval - Basic question about Notified Bodies and their role EU Medical Device Regulations 10
G Question about Non-conformances during New Product Introduction Nonconformance and Corrective Action 14
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
O Mitutoyo Digital Caliper to PC USB question General Measurement Device and Calibration Topics 2
R Probability - Need a help to solve the below question Statistical Analysis Tools, Techniques and SPC 5
B Minitab Type 1 Gage Study on True Position Question Measurement Uncertainty (MU) 1
Q Supplier audit question cataloque VDA Standards - Germany's Automotive Standards 0
Ed Panek Inactive key supplier question - We are not actively buying from them ISO 13485:2016 - Medical Device Quality Management Systems 2
T Potential Off-Label Use question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R Question on determining defective units - I am not recording fixture to part rejected Statistical Analysis Tools, Techniques and SPC 5
Ed Panek Rule 11 Question - CE approvals for software as well as the medical device EU Medical Device Regulations 6
H Question about implications of performing Firmware upgrade via MDDS - Medical Device Data Systems 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom