Labeling for Similar Connectors in a Medical Device

J

jayanthi

#1
Hi all,
In our medical device, we have two connectors in the back panel where we can connect foot switch and another accessory.Both the connectors are of same type .We can connect foot switch and other accessory in any of these two connectors.

In this case how to provide labeling, in the standard i found label for foot switch connection but how can i label another connector?

pl help me to figure out. thanks in advance.

Regards
Jayanthi.
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Hi all,
In our medical device, we have two connectors in the back panel where we can connect foot switch and another accessory.Both the connectors are of same type .We can connect foot switch and other accessory in any of these two connectors.

In this case how to provide labeling, in the standard i found label for foot switch connection but how can i label another connector?

pl help me to figure out. thanks in advance.

Regards
Jayanthi.
Hi Jayanthi.
Have you not established the risk management document for your product from the design stage where this was identified and the control planned accordingly ... ?
If not, please look into it.
Provide a small figure of the accessory as a label close to the correct connector.
 
J

jayanthi

#3
Hi Somasekar,
There wouldn't be any risk if u interchange the connection because both the connectors are internally connected to same port.In this case whether we need to have any control. pl let me know..

And for labeling , shall i put foot switch label near one connector and symbol of that accessory at another one? is it ok?
 

somashekar

Staff member
Super Moderator
#4
Hi Somasekar,
There wouldn't be any risk if u interchange the connection because both the connectors are internally connected to same port.In this case whether we need to have any control. pl let me know..

And for labeling , shall i put foot switch label near one connector and symbol of that accessory at another one? is it ok?
I wish to know if both the foot switch and the other accessory will be connected at the same time, and are operated concurrently. If so, is there still no risk involved.
 
J

jayanthi

#5
Dear Somashekar,
Both the things are connected at the same time , and we are using foot swich for swtiching on/off the equipment remotely and another one at the euipment end.
 

somashekar

Staff member
Super Moderator
#6
Dear Somashekar,
Both the things are connected at the same time , and we are using foot swich for swtiching on/off the equipment remotely and another one at the euipment end.
From the user's point of view, a clear and good label affixed close to the connectors must meet the requirements. (foot switch label; other accessory label)
Additional information can be in the manual with a figure of the connector side of the equipment showing all the labels and a short note of which accessory connects where. These can also be addressed in the risk management document closing the loop.
 
Thread starter Similar threads Forum Replies Date
A Purchasing Controls on Change Management of Literature/Labeling ISO 13485:2016 - Medical Device Quality Management Systems 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
D Hazard symbols and labeling ISO 13485:2016 - Medical Device Quality Management Systems 1
M IEC 62304 Software changes - Minor labeling changes on the GUI IEC 62304 - Medical Device Software Life Cycle Processes 3
D Labeling requirements for reagents, etc ISO 13485:2016 - Medical Device Quality Management Systems 4
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
Anonymous16-2 Labeling Question (Dietary Supplements/Food) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
L Medical-grade power adapter labeling Other US Medical Device Regulations 2
Y Labeling difference for storage and operating conditions EU Medical Device Regulations 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
JoCam Labeling to Customer Requirements EU Medical Device Regulations 1
Z Labeling for Medical Device Samples - Surgical instruments 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Change Control - Product Name Change and its associated labeling EU Medical Device Regulations 7
D Do User Manuals (Not Device Labeling) HAVE to be in their national languages for these countries? Will English Hardcopy not do? EU Medical Device Regulations 12
S How to decide which medical device symbols go on label and labeling? US Food and Drug Administration (FDA) 5
M MDR Legacy Medical Device Labeling compliance timeline EU Medical Device Regulations 3
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
M Labeling for off-label use - Prevention of off-label use of a medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations Medical Device and FDA Regulations and Standards News 0
P UDI labeling for power module IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
A Labeling - 2017/745 - EUMDR Requirements and Trademark Issues EU Medical Device Regulations 0
DitchDigger UDI, Labeling Accessories, General Insanity, Etc. US Food and Drug Administration (FDA) 1
K Labeling requirements - Date of manufacture for software devices EU Medical Device Regulations 5
E Annotated US Prescribing Labeling US Food and Drug Administration (FDA) 0
T Product Labeling - Modified the name of one of our products EU Medical Device Regulations 5
M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0
T Labeling Requirements - Creams in tubes EU Medical Device Regulations 3
K EU MDR Art. 22 - Device + insertion pack - User manual and Labeling EU Medical Device Regulations 4
M MDR 2017/745 sterile and non-sterile labeling EU Medical Device Regulations 12
M Professional Use Medical Software French Labeling for Canada -- Not Considered Medical Device Canada Medical Device Regulations 2
CPhelan Labeling template on QMS - Kitting and labeling documentation Manufacturing and Related Processes 9
G FDA UDI markings "label" vs. "labelling" (labeling)? US Food and Drug Administration (FDA) 4
G How is the labeling of units cleared for both Rx and OTC uses handled? US Food and Drug Administration (FDA) 4
E FDA Supplier Labeling Requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
M Scrubbed version of a labeling procedure that is MDR compliant wanted EU Medical Device Regulations 3
M UDI labeling MDR requirement for reusable medical device accessories EU Medical Device Regulations 12
T Change to Country of Origin on Medical Device Labeling Other Medical Device Regulations World-Wide 0
L EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) - Labeling Content EU Medical Device Regulations 5
I Medical Device Packaging Multilingual Labeling EU Medical Device Regulations 3
T FDA proposed labeling standalone software cloud based US Food and Drug Administration (FDA) 4
M Putting AR's name and address on label - Authorized Representative Labeling Requirements CE Marking (Conformité Européene) / CB Scheme 0
N IFUs with promotional labeling Other US Medical Device Regulations 0
I Requirements for different Labeling Levels 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
K UDI Labeling for Medical Device Samples 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom