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
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