SBS - The Best Value in QMS software

Does the Banana connector deviate from the IEC 60601-2-25?

Roland chung

Trusted Information Resource
#1
Hello folks,

According cl.56.3 of 60601-2-25, the PATIENT CABLE to EQUIPMENT connector and any detachable ELECTRODE lead connectors shall, when separated from the EQUIPMENT or from each other, have no conductive PATIENT connected parts which are capable of contact with a flat conductive surface of not less than 100 mm diameter.

Now, there is a three lead ECG adapter cable. One connector of this cable to EQUIPMENT is DIN type, the other to PATIENT is Banana type (for use with larger alligator clips). Does the Banana connector of PATIENT end deviate from the standard?

Any thoughts would be appreciated.
Roland
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Old type exposed-male-element banana, or new type shrouded male banana?

If old type, I'd think the answer to your question would be yes.
 

Roland chung

Trusted Information Resource
#3
Thank you very much for your input.

It is exposed male banana connector (see attached) and is indeed not uncommon even in today's market. I am wondering if there is an exception for this kind of ECG cable.
 

Attachments

R

raymond02302

#4
This kind of configuration is acceptable,which is listed in the exceptions.This is to taken into account widespread pratice. Refer to rational in ANNEXE AA for this subclause.
 
Last edited by a moderator:
A

arios

#5
Is there a force requirement to pull these connectors out or to push them in into their counterpart connection?
 
Thread starter Similar threads Forum Replies Date
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
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 0
D Change to labelling - does it require a new 510(k)? US Food and Drug Administration (FDA) 5
M What does "constantly" mean ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
0 To which part of 13485 does this refer? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
lanley liao Does the customer`s trademark belong to customer-supplied property? Oil and Gas Industry Standards and Regulations 2
H How does a gas turbine work on diesel fuel? Oil and Gas Industry Standards and Regulations 12
G What does performance specification include? US Food and Drug Administration (FDA) 1
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
B Does anybody know how to get older versions of Minitab to work in Windows 10? Quality Tools, Improvement and Analysis 9
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S How long does it take to register a product with MHRA? UK Medical Device Regulations 8
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
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
N Does anyone have experience of GB/T 34986-2017? China Medical Device Regulations 1
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
B General Motors and Honda Alliance - What does this mean to suppliers? IATF 16949 - Automotive Quality Systems Standard 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18

Similar threads

Top Bottom