Medical Device Marking - Power Input Ports

#1
Looking for recommendation on marking a medical device -specifically the input jack to our device--we use a 12V 15Watt external power supply to power our product. 60601 states "Model or Type of the specified power shall be permanently marked on the outside of the equipment..."
We use a generic medical approved power supply, so "model" wouldn't be appropriate. Is the Type? 12V 1.2A with a marker showing the polarity adequate for the "TYPE"?
What about font size?
Does the marking need to be adjacent to the jack or can it be on a label on the product?
Any help welcome!
 
Last edited:
Elsmar Forum Sponsor
P

philou49

#2
Re: Device Marking Help - Power Input

On our last certification in compliance with 60601-1 we had the same issue and here is what has been approved (We have an external 12V 2.5A power)
On the identification plate : 12V (symbol for DC voltage) 25VA
Near the jack connector: 12V (symbol for DC voltage) + polarity symbol.
But it may be lab dependant.
Note: do your lab accept "generic" medical power supply. Our lab requested that we identified all acceptable power supply in our IFU and to test all of them for power consuption + heat and also EMC (conducted and radiated) !
 

Mark Meer

Trusted Information Resource
#3
Re: Device Marking Help - Power Input

Our experience is the same, with the additional consideration of the Class II symbol (if applicable) as required by 7.2.6.

7.2.6 says "preferably adjacent to the connection point" (emphasis added), so it's a good idea to have a marking by the actual connector.

There is no specific requirement for font-size. ...but of course, it should be legible and permanently affixed.


...do your lab accept "generic" medical power supply.
Good point. Likely the test lab will list the power supply as a critical component. Thus, while your chosen power-supply may have been sourced as "generic", in terms of 60601-1 testing, the power-supply is "specific".
 
Thread starter Similar threads Forum Replies Date
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 2
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 8
A EAC Marking in Medical Device Other Medical Device Regulations World-Wide 0
CPhelan Do you require MDSAP for CE Marking of a Medical Device or is ISO13485:2016 with clinical data sufficient? CE Marking (Conformité Européene) / CB Scheme 6
S CE Marking requirements - A Medical device with different config sold under same name EU Medical Device Regulations 0
F CE Marking Algorithm for an IVD use only Medical Device EU Medical Device Regulations 7
M Partial Compliance to an ISO Standard for Medical Device CE Marking EU Medical Device Regulations 13
L Electrical Class (Class I, II & III) vs. Medical Device CE marking Class I, II & III ISO 13485:2016 - Medical Device Quality Management Systems 3
T Risk Analysis help for CE Marking Class I Medical Device ISO 14971 - Medical Device Risk Management 10
T CE Marking Medical Device and classification CE Marking (Conformité Européene) / CB Scheme 6
A Tests required for CE Marking a Class 2A Medical Device EU Medical Device Regulations 6
5 Help with Medical Device Class IIa Annex V CE Marking Document Control Systems, Procedures, Forms and Templates 1
P Class 1 Medical Device Labeling and CE Marking Requirement EU Medical Device Regulations 8
B Question for CE Marking of Medical Device (Directive 93/42/EEC) EU Medical Device Regulations 2
R Class II Medical Device Marking - Different IEC 60950 & IEC 60601 Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 17
B CE Marking Components of a Medical Device CE Marking (Conformité Européene) / CB Scheme 2
B CE-Marking on Class III Medical Device Products: How? CE Marking (Conformité Européene) / CB Scheme 5
A CE Marking - Annex II Requirements for Class IIa Medical Device EU Medical Device Regulations 5
C Medical Device Reporting Procedures compliant with FDA and CE Marking Requirements EU Medical Device Regulations 7
E IEC/EN 60601 Testing and CE Marking for a Non Medical Device CE Marking (Conformité Européene) / CB Scheme 11
bio_subbu Basic Primer on how to obtain European CE Marking for a Medical Device EU Medical Device Regulations 0
V CE Marking for Device under (Research and Education) Non Medical. CE Marking (Conformité Européene) / CB Scheme 3
M Medical Device Variants submission for CE Marking - Class II Medical Device EU Medical Device Regulations 8
J CE Marking a CE marked Class I Medical Device - To aid approval/registration in China EU Medical Device Regulations 7
N CE Marking Medical Device with Software - together or separate? EU Medical Device Regulations 4
L CE marking on medical device components/replacement parts EU Medical Device Regulations 5
R CE Marking for Research Instruments - Small Company - Class II Medical Device EU Medical Device Regulations 3
K Independent authorized CE Marking representative in UK or EU - Class 1 Medical Device EU Medical Device Regulations 11
N Could anybody suggest a routemap for CE marking for invitrodiagnostic medical device? ISO 13485:2016 - Medical Device Quality Management Systems 4
C Class I Medical Device - What is in a CE Marking Self-Declaration EU Medical Device Regulations 18
V CE Marking for Power Supply for Medical Device - Class IIb device per MDD, Rule 11 EU Medical Device Regulations 3
C CE marking - Medical Device - Must have our name and address on it? EU Medical Device Regulations 4
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3

Similar threads

Top Bottom