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
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.
 
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
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 4
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
B ISO 17025:2017 risk management Risk Management Principles and Generic Guidelines 0
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet ISO 26262 ISO 26262 - Road vehicles – Functional safety 3
Marc ISO 26262- Road vehicles – Functional safety ISO 26262 - Road vehicles – Functional safety 0
John C. Abnet ISO 26262 IATF 16949 - Automotive Quality Systems Standard 0
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
K PDCA cycle and ISO processes alternative model Quality Management System (QMS) Manuals 14
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
D Which ISO Standard to purchase? ISO 13485:2016 - Medical Device Quality Management Systems 7
V ISO 10360-5: 2020 Gap analysis and Action plan Excel .xls Spreadsheet Templates and Tools 1
Q ISO 9001 - Reseller Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 45001 6.1.2.1 Hazard Identification Occupational Health & Safety Management Standards 1
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2
S Any ISO standards around Artificial Intelligence and Machine Learning? Medical Information Technology, Medical Software and Health Informatics 4
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
N ISO 9001 - Training business with fewer than 5 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
J Opportunity in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
B ISO 6508 and portable hardness measurement instruments General Measurement Device and Calibration Topics 0
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2

Similar threads

Top Bottom