How to apply external voltage to SIP/SOP

Benjamin Weber

Trusted Information Resource
#1
Since SIP/SOP with external voltages is a current topic in some discussions here I would like to raise the following question:

Consider a ME equipment which has its own mains supply connection but that is controlled by another PC (no ME equipment) via USB. The ME equipment can only be operated when the PC is connected and a connection is established. If I wanted to apply mains voltage to the USB I couldn't operate the ME equipment properly, e.g. to bring it to its maximum power input. The ME equipment would just be in some kind of standby mode.

Do you think that is OK to do so? Or should I try to bring the ME equipment to operation and simultaneously apply mains voltage to the USB? I don't have any idea how this could be done, to be honest.

Best regrads,
Benjamin
 
Elsmar Forum Sponsor

VinceTech

Involved In Discussions
#2
Hi,
my understanding is.the ME equiomwnt is.connected to a PC through a USB. Before answer this question, you may need to determine how is this USB is isolated from the PC. Is PC's USB 2MOP isolated from mains? if the PC isolation is not specified, you need to apply mains to both ME and USB SOP/SIP. If PC &USB is 1MOP, MAINS shall be applied to SIP/SOP in SFC.

Just personal view, please advise.
 

Benjamin Weber

Trusted Information Resource
#3
OK, I try to explain my problem a little more detailled:

Let us assume the case I have seen most: The device itself is powered via a power supply cord from the mains supply. To operate the device a PC is connected via USB, there is no other way to control the device. The USB port shall be separated by 2MOPP for a working voltage of 240Vrms (maximum mains voltage) from accessible and applied parts. Mains voltage at the USB port is considered normal condition because there is no restriction from the manufacturer what kind of PC shall be connected, IEC 60601-1, cl. 8.1 a). In order to operate the device correctly and bring it to normal operation, the USB connection to the PC must be established and the control software must run at the control PC. Maybe there is even a relay in the device, that closes the mains part only when the USB connection is OK and the software can give the correct command.

If I wanted to apply 240 Vrms to the USB lines (all connected together incl. shield, otherwise I would probably have a breakdown in the USB connectors itself), the device will not operate, maybe the relay mentioned above wouldn't even close. Is it sufficient to perform e.g. touch current measurement this way? Or should I try to close the relay by an external signal voltage? OR should the manufacturer provide any means to operate the device, if it cannot be operated normally in this setting? Or should I consider the not-operating device as normal condition/operation because it would never be functional, if mains voltage is present at the USB lines?

Are there other testers, that would share their experience with us?

Kind regards,
Benjamin
 
Thread starter Similar threads Forum Replies Date
F Calibration Tags - External company applied their tags - Do I need to apply our tags Document Control Systems, Procedures, Forms and Templates 6
M Does 4.5 - Alternative RISK CONTROL apply to the Particular Standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J In-house (NHS) manufacture and use (by staff) of non-medical devices.. any regulations apply? UK Medical Device Regulations 6
S MDR - System and procedure pack article 22 and all sub processes that apply ISO 13485:2016 - Medical Device Quality Management Systems 0
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
shimonv Worthwhileness for a small startups to apply for EUA (Emergency Use Authorization) for COVID-19 US Food and Drug Administration (FDA) 17
qualprod Records where apply and stop recording everything? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Operator protection - When to apply table 7, Dielectric strength test voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
G Do HIPAA Rules Apply to a 3rd Party Logistics Shipper? Other US Medical Device Regulations 2
D Do purchasing controls apply to non-medical parts? ISO 13485:2016 - Medical Device Quality Management Systems 5
G Does pitch/increment/resolution of a ruled scale apply to measurement uncertainty as line item? Measurement Uncertainty (MU) 10
D Monitoring and measuring resources - Example of how section ISO 9001 7.1.5 would apply to a manufacture of software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C Does ITAR apply to Exporters only? Other ISO and International Standards and European Regulations 6
E Does CQI-23 (Molding Sys. Asses.) apply to RUBBER molding? IATF 16949 - Automotive Quality Systems Standard 2
M Informational From RAPS – UK NB Will Not Apply for EU MDR/IVDR Medical Device and FDA Regulations and Standards News 11
B Does EMC Directive 2014/30/EU cease to apply when the Machine Directive 2006/42/EC is applicable? CE Marking (Conformité Européene) / CB Scheme 4
E Discussion between co-worker on tolerance and uncertainty and how to apply it. Thoughts? 17025 ISO 17025 related Discussions 1
B How to assess which directives and standards apply - Brewing and distilling products CE Marking (Conformité Européene) / CB Scheme 1
N Student trying to apply Lean Six Sigma on a Construction project in my thesis Lean in Manufacturing and Service Industries 3
F Device Standards - Managing Changes to existing standards that apply to our devices Other Medical Device Related Standards 1
armani ISO 9001:2015 - How to apply 7.1.5 to an organization performing only design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
F What directives/regulations apply to Analyte Specific Reagents (ASRs) in EU EU Medical Device Regulations 0
F Can an individual apply for an MDEL in Canada, as an establishment? Canada Medical Device Regulations 6
N Apply control limits to a non-normal distribution Statistical Analysis Tools, Techniques and SPC 13
M IATF Clause 8.4.2.2 - What procedures does this apply to? IATF 16949 - Automotive Quality Systems Standard 1
S Optical coherence tomography (OCT) device - Do we need to apply IDE? Other US Medical Device Regulations 0
R Communication of CSR's throughout the organization and who they apply to IATF 16949 - Automotive Quality Systems Standard 4
M Apply for a job when no opening is posted? Career and Occupation Discussions 64
M AS9100 D - How to apply 8.1.1-8.1.4 to a coating service AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Does ISO 10993 Apply to Packaging? (e.g. Travel Case) Other Medical Device Related Standards 4
C Optic Patchcord Cables - Does 8.3 (Design) Apply Here? ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Does the Scope of 21 CFR Part 820.72 (Equipment) apply to Design? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Does IATF 16949:2016 Clause 7.3 (now 8.3) Apply to "Grandfathered" Products IATF 16949 - Automotive Quality Systems Standard 4
Moncia Tall Manufacturer - VDA Audit - Which parts of the audit apply to us? IATF 16949 - Automotive Quality Systems Standard 4
Q How to apply 21 CFR Part 11 and/or cGMP in the Life Sciences industry Qualification and Validation (including 21 CFR Part 11) 3
V When and How to apply the Bayes Success Run approach for Sample Size Determination Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
A 3 scenarios of accident and I want to apply OHSAS18001 Occupational Health & Safety Management Standards 2
I ISO 26262 standard may apply to automotive IC suppliers IATF 16949 - Automotive Quality Systems Standard 1
GStough Looking to Apply for IRCA Certification Using 2nd Party Audits Career and Occupation Discussions 2
M Does AS9120 (aerospace first article inspection) apply to all customers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J If/how to apply LVD (Low Voltage Directive) in this case CE Marking (Conformité Européene) / CB Scheme 6
A How soon can I apply for ISO 9001:2015 certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J Who needs to apply for a CLIA waiver 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Does Record Control apply to the company business processes as well? Records and Data - Quality, Legal and Other Evidence 6
P When can we apply DOE (Design of Experiments)? Six Sigma 8
L AS9100 7.5.2 Special Processes - Clean Room Apply? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Not sure what standards apply to non-electrical patient bed EU Medical Device Regulations 6
A Shall I apply for this job position (Quality Manager)? Career and Occupation Discussions 5

Similar threads

Top Bottom