ISO 80369-7 standard - Interpreting which Parts should be in scope

#1
Hi Guys
I need some help in interpreting the scope of this standard.
The scope in ISO 80369-7 states that "....These small bore connectors are used in medical devices or accessories intended for use with a PATIENT.

How to interpret "with a PATIENT'.

I have got 2 situations:
1. This single use device has a luer connector but as per IFU that should be used for flushing the device outside the patient but in some rare circumstances the surgeons use that connector when the device is connected to the patient. would classify this connector a Luer.
2. In the above device there is another 'Luer' shaped connector which is connected via a tubing to first connector...in turn connecting to the device. this connector is not supposed to be used by the doctor but they can take both the Luers and tubing off exposing the female Luer on the main device. so would you classify the second connector as Luer.

I am sure I have confused some of you.

Any feedback will be appreciated.

Regards
 
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#3
Ronen
Thanks for the comment.

In scenario 1 the Luer is used to flush the device outside the patient. it is more like a preparatory step than actual usage on the patient. would you still classify that as being used "with a patient".

In scenario 2 the 'another Luer' is an intermediary and as per IFU the physician is not supposed to access it but the current design allows it.

Thanks
Daljit
 

Ronen E

Problem Solver
Staff member
Moderator
#4
The scope in ISO 80369-7 states that "....These small bore connectors are used in medical devices or accessories intended for use with a PATIENT.
I'm not sure where you took this phrase from - I don't see it in the Scope section of ISO 80369-7:2016.
 
#6
I think it will come down to how we define 'with a PATIENT'.
Does it mean whether the Luer part directly connects with the patient?
 

Ronen E

Problem Solver
Staff member
Moderator
#7
In my understanding of the English language, In that sentence the phrase intended for use with a patient qualifies accessories or medical devices and accessories (the latter seems a bit redundant since medical devices, by definition, are intended to be used "with a patient"). Not small-bore connectors. So as long as the connector is part of a device/accessory that is intended for use with a patient, that connector is within the scope regardless of the connector's exact role in that device/accessory.

In a less linguistic view, I can't imagine you convincing any auditor that a Luer connector which is part of a medical device is not within the scope of ISO 80369-7, unless your device falls under one of the intended uses explicitly excluded in ISO 80369-7's Scope section.
 
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