ISO 80369 Part 3 Status - Small-Bore Connectors for Liquids and Gases in Healthcare

chris1price

Trusted Information Resource
#1
Hi

A new set of standards are being drafted to replace Luer Conntectors on medical devices. These are under the title of ISO 80369 "Small-bore connectors for liquids and gases in healthcare applications". Part 1 - "General Requirements" is currently out for discussion, and Part 2 is being worked on.

Does anyone know the status of Part 3 "Connectors for Enteral Applications"?

Chris
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
Re: ISO 80369 Small-bore connectors for liquids and gases in healthcare

The proposal for Part 3 is still under development. There will be a meeting of JWG 4 in January, and PG 3 on enteral will meet there. I hope the NWIP proposal will be finalized at this meeeting.

Just for an update for all: Part 1 is on DIS, and the DIS vote will end tomorrow. Part 2 is on CD and the vote ended last month. Part 6 is on NWIP and also ended last month.

I think this series of standards will have a big impact on medial device manufacturer and would like to hear opinions on that, if anyone has....i´m findind it difficult to raise the awareness on this here in Brazil.
 

chris1price

Trusted Information Resource
#3
Re: ISO 80369 Small-bore connectors for liquids and gases in healthcare

Thanks, I agree it will have a big impact on many types of device and it does have little visabity.

NWIP - New work Item Proposal??

From your experience, when do you think the draft of Part 3 will be available for comment and how long before the final standard is published?

Chris
 

Marcelo

Inactive Registered Visitor
#4
Re: ISO 80369 Small-bore connectors for liquids and gases in healthcare

NWIP - New work Item Proposal??

From your experience, when do you think the draft of Part 3 will be available for comment and how long before the final standard is published?
Yes, NWIP means New Work Item Proposal.

The WD of 80369-3 has been in development for almost a year, so i think it will be finished and circulated after the january meeting (please keep in mind that i´ve not been directly envolved up until now, but i will from now on, so this is information i´m gathering from docs).

Regarding the timeframe, after the proposal is accepted, there´s usually 2 to 3 years to publish..i would say that in this case i think 2 uears might be it.

I´m trying to decide if i´m attending the January meeting, but i´m not sure i will manage it due to another pre-planned trip, let´s see.
 
K

KaCey1

#5
Re: ISO 80369 Part 3 Status - Small-Bore Connectors for Liquids and Gases in Healthca

Hi,
I have a couple of questions regarding enteral connectors, and the implementation of the ISO 80369-3 standard (when it is released).

In Annex B of ISO 80369-3 there are two different table that are named B.1 and one named B.2.
In these tables there appears to be two different sets of dimensions for the male and female connectors. Does anyone know why this is, and which one should be used?

Also would anyone know what is meant by the following that is on page v of ISO CD 80369-3? Does it mean that a manufacturer should not try and make connectors that meet this standard until 3 years after publication as the Member Body will not adopt it until at least this time (for new equipment)?

"The attention of Member Bodies and National Committees is drawn to the fact that equipment MANUFACTURERS and testing organizations may need a transitional period following publication of a new, amended or revised ISO or IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production."

A steer in the right direction would be greatly appreciated!

Thanks
 

Marcelo

Inactive Registered Visitor
#7
Re: ISO 80369 Part 3 Status - Small-Bore Connectors for Liquids and Gases in Healthca

In Annex B of ISO 80369-3 there are two different table that are named B.1 and one named B.2.
In these tables there appears to be two different sets of dimensions for the male and female connectors. Does anyone know why this is, and which one should be used?
Are you talking about the last CD? The standards had not been published yet. There´s a problem with the tables, table B.2 will probably be removed.

Also would anyone know what is meant by the following that is on page v of ISO CD 80369-3? Does it mean that a manufacturer should not try and make connectors that meet this standard until 3 years after publication as the Member Body will not adopt it until at least this time (for new equipment)?

"The attention of Member Bodies and National Committees is drawn to the fact that equipment MANUFACTURERS and testing organizations may need a transitional period following publication of a new, amended or revised ISO or IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production."
This is just a reminder text and suggestion that is being used now in ISO and IEC. Although ISO and IEC don´t deal with the use of standard (only with creating them), they were asked to put a reminder (to users and to ones which might required the standard, such as regulators) that a transition period is desirable. Anyway, it´s just a suggestion.
 

Marcelo

Inactive Registered Visitor
#8
Re: ISO 80369 Part 3 Status - Small-Bore Connectors for Liquids and Gases in Healthca

Any update on the progress of ISO 80369 series?
The comments for the CDs of parts 2, 3 ,4, 5, 6 and 7 have just been circulated. They will be discussed in the next meeting of JWG 4 in Paris, in September. Part 1 will probably be revised. There´s a proposed new document on connectors for enteral feed/solution reservoirs.
 
K

KaCey1

#9
Re: ISO 80369 Part 3 Status - Small-Bore Connectors for Liquids and Gases in Healthca

Thank you Marcelo your comments help a lot. You are correct I was referring to the last CD.

Another couple of general questions if you don't mind! Is it possible for a small manufacturer to join the consultation process? and how is it possible to keep up to date with the progress of the proposed new standard (is there a particular body that companies can register with)?
 

Marcelo

Inactive Registered Visitor
#10
Re: ISO 80369 Part 3 Status - Small-Bore Connectors for Liquids and Gases in Healthca

Another couple of general questions if you don't mind! Is it possible for a small manufacturer to join the consultation process? and how is it possible to keep up to date with the progress of the proposed new standard (is there a particular body that companies can register with)?

Yes, the process is really open to anyone willing to participate.

You need initially do that thru your National Commmitte - NC (not sure where you are from). There´s a list of participating and observing countries on TC 210 with links to NCs here - http://www.iso.org/iso/home/standar...ical_committee_participation.htm?commid=54892.

Usually the NC has a mirror committee, and you need to begin participating in this mirror. The mirror committees receive draft, which they analyse and vote (participating countries have vote privilage, and they can also appoint experts to working groups in ISO - those experts are the drafter of the standards).

If there´s no mirror committee, you need to ask your NC how to participate.

For more information regarding the process, please refer to http://www.iso.org/iso/home/standards_development.htm
and http://www.iso.org/iso/home/standards_development/resources-for-technical-work.htm

Another good reads are the documents "Joining in Participating in International Standardization" and "My ISO Job - Guidance for delegates and experts", which i attached to this post.
 

Attachments

Thread starter Similar threads Forum Replies Date
P ISO 80369 and endoscope port/lumen Other ISO and International Standards and European Regulations 4
P ISO 80369-7 standard - Interpreting which Parts should be in scope Other Medical Device Related Standards 7
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
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 10
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