SBS - The best value in QMS software

USB powered handheld medical device - Isolation requirements

#1
Hello,
I have to develop a medical device which is connected to a standard PC by a USB cable.
The device will take power from the USB port. The cable will do directly into the handheld section (no connector) - which is a large lump of plastic, and there are no accessible metal parts. The closest a fingertip could possibly get to any internal conductors would be if the user held the cable with their tingertips.
Am I correct in thinking that there would be no requirement for galvanic isolation from the PC USB port, as the plastics already provide all the galvanic isolation required?
Any advice gratefully received.
 
Elsmar Forum Sponsor

Peter Selvey

Staff member
Moderator
#2
The decision is mostly based on the way the device interacts with the patient. It's OK for the user to contact the USB circuit directly, it is "safe" on the assumption that the PC complies with the relevant safety standard (IEC 60950-1).

However, 950 isolation is not good enough for the patient, so to comply with IEC 60601-1 there will need to be some additional barrier to the patient. Sometimes this is inherent in the design (the parts that contact the patient are naturally plastic), sometimes another isolating barrier is needed. And in some cases it could be argued that even though it technically fails IEC 60601-1, the type contact with the patient is nothing special so the additional requirements in that standard don't make sense. Anyway, it all comes down to the type and nature of patient contact.
 
Thread starter Similar threads Forum Replies Date
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
S Medical watch Class II (AP Type CF) with USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
R Classification of USB DC operated medical equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K USB VID/PID certification Various Other Specifications, Standards, and related Requirements 2
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
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
S Battery powered device - electrical protection requirement IEC 60601 - Medical Electrical Equipment Safety Standards Series 18
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 11
J Powered wheelchairs (Class IIa) in the process of CE marking and use in hospitals CE Marking (Conformité Européene) / CB Scheme 4
R ISO 10079-1:2014 on electric powered nasal aspirator Other US Medical Device Regulations 0
L DC Powered Medical Device Fuse / 15.4.3.5 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
T Battery Powered Device - MOP and Patient Auxiliary Currents IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
J IEC 60601-1 Electrical Safety testing - Class 1 ME externally powered - Earth resistance testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E CB scheme applicability for battery powered medical devices CE Marking (Conformité Européene) / CB Scheme 0
F MOPP in battery powered device with metal enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C Lithium battery powered Medical Device - 15.3.3 Impact test, broken enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
B Dielectric Test of Battery Powered Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
E Electrical safety (battery-powered medical device) EU Medical Device Regulations 1

Similar threads

Top Bottom