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
 
Elsmar Forum Sponsor
#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
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
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.
 
Thread starter Similar threads Forum Replies Date
P ISO 80369 and endoscope port/lumen Other ISO and International Standards and European Regulations 4
E Compliance to standards (ISO 80369) but the ID is out of specification Other ISO and International Standards and European Regulations 0
R ISO 80369-7 Publication Date - 10/14/2016 Other Medical Device Related Standards 7
chris1price ISO 80369 Part 3 Status - Small-Bore Connectors for Liquids and Gases in Healthcare ISO 13485:2016 - Medical Device Quality Management Systems 17
K Applicable ISO 9001 clauses for Human Resources? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Clinical Trial using Prototype devices (EU MDR & ISO 14155) EU Medical Device Regulations 3
I IEC 60812 or ISO 14971 for PFMEA? What should we use? ISO 14971 - Medical Device Risk Management 3
I ISO 9000 Where to Start ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
M ISO 13485 consultants and auditors with design oriented focus ISO 13485:2016 - Medical Device Quality Management Systems 5
D ISO 9001:2015 Internal Audit Check Sheet ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
H Does ISO state in anyway that we MUST keep physical first piece parts? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B ISO cl. 5.3 - Ensuring that the integrity of the QMS is maintained ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A ISO 9001- any advise please with transitioning from a paper based system to eQMS and multi site scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
L ISO 20417 crucial changes Other Medical Device Related Standards 1
R ISO 27001 Mandatory Policies , Procedures and Records IEC 27001 - Information Security Management Systems (ISMS) 0
R Use of historical version of ISO standards CE Marking (Conformité Européene) / CB Scheme 3
I QMS and ISO 9001 Misc. Quality Assurance and Business Systems Related Topics 11
E ISO 17025 Key Performance Indicators (KPIs) ISO 17025 related Discussions 5
A ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J ISO 9001:2015 Clause 8.2.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
LabCat Internal SOP for a validated (ISO) method? ISO 17025 related Discussions 2
L Confusion about ISO 14644 Other Medical Device Related Standards 2
GStough Audit Nonconformances (?) for Suppliers Not Registered to ISO and No Supplier Quality Agreement Exists General Auditing Discussions 24
S Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require? EU Medical Device Regulations 2
M Is complete testing required as per ISO 10993 for materials used in orthopedic implants or is literature review route possible Other Medical Device Related Standards 3
Aliken Recommendation for the ISO 13485 certification company ISO 13485:2016 - Medical Device Quality Management Systems 7
ISO-tired ISO 13485: file structure overview ISO 13485:2016 - Medical Device Quality Management Systems 11
J ISO 10993-1:2018 Format to Perform Risk Management Process US Food and Drug Administration (FDA) 1
B ISO 9001:2015 Registered Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C ISO Cert and Parent Company is not Certified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
B Is 14971 Annex C checklist now in ISO/TR 24971 required to complete prior to 510k filing? ISO 14971 - Medical Device Risk Management 3
Q ISO Training Providers to fix careless workers? Training - Internal, External, Online and Distance Learning 19
M PROBLEM IN SCOPE OF ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
S ISO 13485 signing of Procedures etc. ISO 13485:2016 - Medical Device Quality Management Systems 10
N ISO 13485 Scope Reduction Other ISO and International Standards and European Regulations 2
Sidney Vianna ISO 37301 - Compliance management systems – Requirements with guidance for use Other ISO and International Standards and European Regulations 2
S ISO 3497 Metallic Coatings Other ISO and International Standards and European Regulations 1
R Basic Lab Practices - related to ISO 17025 testing labs ISO 17025 related Discussions 1
JDJohnson Micrometer & Caliper Calibration (ISO-9001) General Measurement Device and Calibration Topics 26
M Can veterinary implants be ISO 13485 certified? ISO 13485:2016 - Medical Device Quality Management Systems 23
D Audit Report details when ISO 13485:2016 and cGMP 21 CFR 820 are applicable ISO 13485:2016 - Medical Device Quality Management Systems 6
G Why do you guys think ISO 9001 doesn't ask specifically for preventive maintenance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
D Training for ISO 17025 ISO 17025 related Discussions 2
R Looking for ISO 13485 Internal Audit Checklist ISO 13485:2016 - Medical Device Quality Management Systems 8
FuzzyD ISO 13485 change in process ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 9001:2015 Calibration Procedures Manufacturing and Related Processes 16
R Interesting Discussion Chapter 7.5 of ISO 13485 for manufacturers of mobile medical applications ISO 13485:2016 - Medical Device Quality Management Systems 4
J ISO Certificate Expiration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
V ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION? ISO 13485:2016 - Medical Device Quality Management Systems 4
G Auditing Top management: 6.3 ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7

Similar threads

Top Bottom