USB VID/PID certification

KrishQA

Starting to get Involved
#1
Hello All,

I am not sure this is the right forum but posting anyway.

So we have a medical drug dispensing device that has the capability to connect to a PC via a cable to download the logs. The question I have is when does it become important to have USB certification and get a VID/PID? The company would not need to advertise the USB capability or anything, it is just a fringe requirement where the user may choose to use it for the logs.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
I don't know about USB certification but you are saying a) you're a medical device; and b) have an external access port. For a) you just have to comply with applicable medical device regulations, including electrical concerns, possibly including labeling for the cable, etc. The fact that you have an external access port is probably going to be your bigger headache. Now you have cybersecurity concerns, data protection concerns, usability concerns, ...
 

KrishQA

Starting to get Involved
#3
@yodon Yes, we have identified cyber security risks and respective mitigations. The early call was to disable the USB due to cybersecurity concerns. The stakeholders later decided to have it just to collect some logs from the device.

The conversation then moved to USB certification. From my initial research I can see that the certification is more for marketing purposes and using the trademarked logos. None of the medical regulations talk about it (I haven't seen them anyway)
 
Thread starter Similar threads Forum Replies Date
S Medical watch Class II (AP Type CF) with USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
F USB powered handheld medical device - Isolation requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Classification of USB DC operated medical equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
E SIP/SOP requirements for USB port used for charging IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Isolation requirements for USB/Ethernet IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
O Mitutoyo Digital Caliper to PC USB question General Measurement Device and Calibration Topics 2
K USB DC operated medical equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B USB-Connection - Creepages and Clearances IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Medical Device Software Distribution for a CE-marked medical device via a USB memory stick EU Medical Device Regulations 8
S Development of 2xMOPP galvanic isolator for USB-connected device IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
L PC in patient environment - BF applied part that uses USB to connect to PC IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
N USB Powered EEG - USB provides 1 MOPP want 2 MOPP IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
M Labelling Requirements for USB-Powered Device Other Medical Device Related Standards 1
K UL 6601 - Would an off-the-shelf Android tablet, powered by USB, pass UL 6601? Other Medical Device Related Standards 3
R USB power between Medical Device Data Collection Device Component IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
P HIPAA Privacy - Login password or USB Access key? Other US Medical Device Regulations 3
U USB Connector Operator Protection (MOPP) IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
E Safety Requirements for Bioimpedance Measuring Device Power via USB Cable IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K USB Charger Adapter/USB Cable - A Medical Device Accessory? EU Medical Device Regulations 2
C Medical device worn on body with USB, isolation, 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S How can I justify adequacy of USB connector soldered on the product Reliability Analysis - Predictions, Testing and Standards 4
J Cost Effective Solution for Isolating USB 5V 500mA Power IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Off the Shelf Parts - Serial to USB adapter for a Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q Mitutoyo USB Cables for Variables Data Collection using a Dial Snap Gage Statistical Analysis Tools, Techniques and SPC 2
T USB Drive Encryption and Protection After Work and Weekend Discussion Topics 5
C USB, Clearances and Earth Leakage - Medical Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S Off the shelf Serial to USB Adapter Impact on 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S USB Cable (an accessory to our data management software) Changes and 510k IEC 62304 - Medical Device Software Life Cycle Processes 2
I Minitab 14 USB Hardware Key Availbility Using Minitab Software 7
C USB dongle licensing system for Medical Imaging Software Other Medical Device and Orthopedic Related Topics 1
A Medical device with NON medical PC - USB galvanic insulation ISO 13485:2016 - Medical Device Quality Management Systems 2
A USB Port Isolation as per IEC60601-1 - Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
R USB Port (Signal I/O) Isolation as per IEC60601-1 - Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 40
T Calibration of a digital usb temprature probe. General Measurement Device and Calibration Topics 3
Jen Kirley Have you tried recording vinyl to MP3s and or CDs? Turntable with USB port? After Work and Weekend Discussion Topics 22
Marc Credit Union Audit - Social Engineering, the USB Way After Work and Weekend Discussion Topics 2
J Free USB Drive from Microsoft! After Work and Weekend Discussion Topics 47
L Class 2b USB enabled diagnostic devices...Clinical trials ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom