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

[chris1price]

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

[Marcelo Antunes]

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]

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 Antunes]

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.

[KaCey1]

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

[pseudoazurin]

Any update on the progress of ISO 80369 series?

[Marcelo Antunes]

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 Antunes]

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.