USB power between Medical Device Data Collection Device Component

#1
Here is the current (no pun intended) state;

We make a medical device that has two components, a medical grade tablet computer and a proprietary data collection device which has been tested and meets 60601-1 requirements. Each is powered by its own medical grade external power supply.

The future state still has both of the components, The tablet computer is still powered by it external power supply, but the data collection device is powered via USB from the tablet computer.

My question is if I need to repeat the electrical safety testing on the data collection device since I have changed the way it is powered?

Thanks for your help,

Ray
 
Elsmar Forum Sponsor
P

philou49

#3
It depends on the way your insulation design is done. And the way your have promote your device to the test lab.
If the external power supply is part of your certification (as critical component) when removing it cancels the certificate.
If your device was tested as powered by USB port (with a statement that USB power provider is IEC60601 o r IEC60950 ) then you are quite safe.

Usually when using and external power, most of the safety (MOOP, MOPP) are inside the power.
So if it is powered by tablet, the tablet should insure the same safety level.
Take care also that if you tablet wasn't certified to provide power to other device, NB could ask to update your safety test for the tablet
 
R

Rini_simon

#4
If previously it was powered via external power supply and now being powered by Tablet (assuming the rating of the data collection device has not changed) and is same as when it was connected to external power supply ) which is already approved to 60601, then some points to keep in mind are:

a) you might not have to repeat all the tests, maybe a partial evaluation with USB connector (SIP/SOP).

b) if the data collection device can be used while it is being connected to Tablet (charging mode), then it would be better to specify in manual that it has to be connected to your tablet (model and mfr must be specified). If there are no restrictions placed in the manual then it depends on the test lab how they will assess this situation.
 
Thread starter Similar threads Forum Replies Date
E Safety Requirements for Bioimpedance Measuring Device Power via USB Cable IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J Cost Effective Solution for Isolating USB 5V 500mA Power IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
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
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
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
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
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
L Medical-grade power adapter labeling Other US Medical Device Regulations 2
A Calibration of Power Supplies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
B IEC 60601 Cl. 8.4.3 - ME EQUIPMENT intended to be connected to a power source by a plug / Plug discharge IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Proud Liberal Power Query to combine multiple tables of unequal number of columns Statistical Analysis Tools, Techniques and SPC 1
J Universal Power Cord with Adapters - IVD IEC 61010-2-101 CE Marking (Conformité Européene) / CB Scheme 6
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
L IEC 62368-1 / Electrical Energy Source vs. Power Source? CE Marking (Conformité Européene) / CB Scheme 2
B Need For BIS Standard Mark? Imported OEM's Power supply,Li-Ion Battery Other Medical Device Regulations World-Wide 0
I Containment procedure for parts after a power outage. IATF 16949 - Automotive Quality Systems Standard 1
P UDI labeling for power module IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
E IEC 61010-1 Dielectric strength test of inner power supply Other ISO and International Standards and European Regulations 0
S Power rating for medical devices in the US - Radiotherapy devices US Food and Drug Administration (FDA) 0
T Is anyone working with N299.1 (Supply/service to nuclear power plants)? Various Other Specifications, Standards, and related Requirements 0
E IEC 60335-1 power input deviation - Table 1 Values Other ISO and International Standards and European Regulations 0
H External power supply - requirements in safety/EMC test? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4

Similar threads

Top Bottom