Connection to a generic separate power supply

Roland chung

Trusted Information Resource
#1
Hello everyone,

The clause 8.2.1 of 60601-1 3.1ed states that if a generic separate power supply is specified, then the specification in the accompanying documents is inspected.

Normally, the generic separate power supply doesn't provide with the medical device. It seems that the safety is guaranteed by the user manual only. But, the effectiveness of manual (as a risk control measures) is very weak, especially considering the reasonably foreseeable misuse. It is expected that 60950 grade, or worse power supplies (e.g. knockoff) may be used where 2 MOPP is required, especially for home-use devices (e.g. stimulators). So should 2 MOPP isolation be designed in the medical device when it is intended to be used with a generic sepatate power supply?

Could you please shed some light on this?

Thanks,
Roland
 
Elsmar Forum Sponsor

Pads38

Trusted Information Resource
#3
Hi Roland,

I think you have basically answered your own question. You have identified, by Risk Management, that using a "not controlled" power supply is reasonably foreseeable misuse, and the probability of such misuse is quite high.

So, if you cannot rely upon 2 MOPP in the PSU then you will need to provide it elsewhere, although you may be able to say that the PSU provides 1 MOPP.
 

Roland chung

Trusted Information Resource
#4
Thank you for your input.

The same question I also asked expert of IEC working group, the answer was that where a generic supply is used It must meet (at minimum) 60950-1 (and that must be required by the instructions). 60601-1 is based on normal use which by definition is as instructed in the IFU. If we assume no one reads or pays attention to the instructions devices are impossible to make safe!

Regards,
Roland
 

Pads38

Trusted Information Resource
#5
My concern with this is it might say it complies with 60950 but can you be sure?

There are so many bad copies of phone / computer chargers, and so many stories of fires being started by them.

To avoid that when we did a device with a "plug top" PSU we used a different connector to enforce the "only use our PSU" rule.
 
A

antonoia

#6
Hello Roland,
clause 7.2.5 gives some options to escape..one is to apply some marking on your connector as risk control.
Second option, you can limit the range of the power supplies that can be used giving details and specification of models and brands that you trust and for what is proved your device complies with the standard. Looking for other comments.. regards!
 
Thread starter Similar threads Forum Replies Date
D Defibrillation protection for patient connection except for electrodes 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 Is there any connection between PFMEA and Acceptance Plan FMEA and Control Plans 1
L Connection between IEC 62304 and Chapter 14 of IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J Connection between Technical File and Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
U PATIENT CONNECTION for HAND-HELD Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
F Functional connection between ME and non-medical equipment in different rooms IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B Detachable Power Supply Cable Connection ESD Clarification IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
Q ME System - Is a Wireless Connection a "Functional Connection"? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
R Appliance Connection for IEC 60601-1-11 Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Is protective earth connection regarded as a part of the applied part? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Wes Bucey Slow Internet Connection After Work and Weekend Discussion Topics 3
optomist1 Contour vs. Profile - Is there a connection between "Contour" & "Profile"? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
P Test Voltages for a Pulse Transformer used to Isolate the Patient Connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
I Connection of Secondary Circuits to Medical Weight Scale Enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
W Patient Circuits / Patient Connection / Applied Parts - Medical Device Definitions IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Jim Wynne Tech Guy Radio: Woman Wants Help in Getting Her Stolen Internet Connection Back After Work and Weekend Discussion Topics 2
Colin Cost of Internet connection in hotels Travel - Hotels, Motels, Planes and Trains 55
L Is there any connection betweeen ISO 14001 and RoHS? RoHS, REACH, ELV, IMDS and Restricted Substances 6
S What is the connection between Ford's phased PPAP and edition 4 from AIAG APQP and PPAP 4
M Connection between DFMEA and PFMEA - What must be transferred to the PFMEA? FMEA and Control Plans 9
T PPAP Appendix F.3 "Customer Plant Connection" - Bulk Materials - Steel Coil Supplier APQP and PPAP 4
V Generic IATF 16949 Audit Checklist wanted IATF 16949 - Automotive Quality Systems Standard 3
V ISO 50001 - looking for a generic checklist Various Other Specifications, Standards, and related Requirements 5
N Generic Rework/Reprocessing Procedure Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
V Generic requirements regarding capability study in automotive Capability, Accuracy and Stability - Processes, Machines, etc. 1
M Is IEC 60601 compliance possible when only generic power-supply is specified? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S Family / Generic type of FMEA & Control Plan and Symbols FMEA and Control Plans 3
Marc The Risks of Generic Drugs Coffee Break and Water Cooler Discussions 24
Marc Are you looking for ISO 31000 - Risk Management Principles and Generic Guidelines? ISO 14971 - Medical Device Risk Management 1
C Appropriate ways to address Competency? Generic vs Specific ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Marc Urine Spills Staining Image of Wockhardt?s Generic Drugs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
Ajit Basrur FDA - Guidance for Industry - Generic Drug User Fee Amendments of 2012 - Q & A US Food and Drug Administration (FDA) 0
M Engineering Change Management Generic Procedure Manufacturing and Related Processes 3
D FDA MDDS - Listing Obligations for a Generic Data Interface US Food and Drug Administration (FDA) 3
R Do generic forms bought over the counter need to be controlled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Should the FSMS have a Documented Generic Procedure for Verification and Validation Food Safety - ISO 22000, HACCP (21 CFR 120) 2
T Generic Guides for Procedure Writing Document Control Systems, Procedures, Forms and Templates 20
S Draft Guidance on Generic Drug User Fee Amendments (GDUFA) 2012 Other US Medical Device Regulations 0
C Control Plan Template (Generic) Document Control Systems, Procedures, Forms and Templates 0
AnaMariaVR2 Generic Drug User Fee Act (GDUFA) US Food and Drug Administration (FDA) 0
I Question on Declaration of Conformity for device subcategory or generic device groups EU Medical Device Regulations 2
P Generic Contract Manufacturing of Generic Prescription Medications Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
A Generic or Specific Gauge R&R on Standard Equipment (ie.: Micrometer) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
Hershal Couple of generic TickIT and ISO 27000 questions IEC 27001 - Information Security Management Systems (ISMS) 9
Q Numbering or Naming (Identification) of Generic Company Specifications? Document Control Systems, Procedures, Forms and Templates 3
S Complaint Process flow: Need a generic definition which would flag an "MDR" Customer Complaints 7
optomist1 Generic question regarding Two Way ANOVA Results Statistical Analysis Tools, Techniques and SPC 8
D Seeking Help: Nondisclosure vs. generic QMS documents Misc. Quality Assurance and Business Systems Related Topics 10
M Generic "Compliant Procedure" and "Non-conformance" forms needed Document Control Systems, Procedures, Forms and Templates 1

Similar threads

Top Bottom