Luer Taper Tolerances - 6% or otherwise - Dimensional Accuracy

Wayne

Gage Crib Worldwide
Does anyone know of a calibration source for these gages. I am having a hard time finding someone who is even knowledgeable about the ISO594/1-1986 requirement.:confused:
Dwight;

In keeping with the rules of The Cove, I try not to be blatantly self-promoting; however, since you ask directly, the company I work for offers calibration services for ISO 594 gages.

Contact Cynthia at [email protected].

Marc, if you need to remove this I will understand.

Wayne.
 

Marcelo

Inactive Registered Visitor
Just as an additional information, please note that ISO/IEC is developing a series of standards on connectors (ISO/IEC 80369 - Small bore connectors for liquids and gases in healthcare applications) which aims to to prohibit the uses of luer locks in most of the applications anddefine different connectors for the different types of application.
 
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Pat McGhie

Wayne,
I know this thread is several years old but I wanted you to know that your links provided me the tools to explain these gages and use to some of our employees..

Pat in NH
 

Wayne

Gage Crib Worldwide
I know this thread is several years old but I wanted you to know that your links provided me the tools to explain these gages and use to some of our employees..
:D I am glad that I was able to be of assisstance. Your post to this thread has caused me to read it again and I notice that I have new information to add. :agree1:

TNHunter said:
Does anyone know of a calibration source for these gages. I am having a hard time finding someone who is even knowledgeable about the ISO594/1-1986 requirement.
Calibration of ISO 594 Luer Reference Fittings and Luer Gages is now available from an A2LA Audited, ISO 17025 Calibration Laboratory which has ISO 594 Luer Reference Fittings and Luer Gages listed in their ISO 17025 Registration Scope.

This is a unique thing. As of this writing I know of no other ISO 17025 Registered Calibration Laboratory with ISO 594 Luer Reference Fittings and Luer Gages listed in their ISO 17025 Registration Scope.

I have had people ask me to have their gages calibrated at their favorite ISO 17025 Registered Calibration Laboratory. While I have no problem with this in theory, I usually find that the ISO 17025 Registered Laboratory is not qualified to check Luer Gages. The worst instance was an ISO 17025 Registered Laboratory which had a Scope that only covered Part Inspection via CMM. :lmao: Read their Scope before sending gages to them. :read:

As always, I hope someone finds this information useful. :yes:
 

Ronen E

Problem Solver
Moderator
Would anyone care to share their experience of the dimensional accuracy of the conical Luer fittings that I perhaps naively believed should have an included angle represented by a 6% slope?

Briefly, we have an issue relating to the mating of an OEM supplied female Luer non-return valve with 'standard' disposable syringes as found ubiquitously throughout the world's healthcare system.

Until very recently I had not needed to consult ISO 594/1 which describes typical dimensions of male and female conical fittings and goes on to describe the requirements in terms of gauging, air & liquid leakage, separation force and stress cracking. So far so good.

However having assembled a collection of disposable syringes made by five different manufacturers and measured the dimensions of the male conical fittings using Vernier callipers it is clear that that actual included angles of this admittedly small sample vary from 4.25 to 5.14%. These items may all meet the gauging and other requirements of the standard, but they certainly don't approach 6%. I do not possess the requisite ring and plug gauges to assess this point at present. Clearly fittings with a more acute angle than nominal would be expected to enter into a mating fitting further than one closer to the nominal.

Is it possible that a female fitting similarly departing from the nominal in the obtuse direction, but still meeting the requirements of the standard would result in the two components bottoming out before a secure joint is made?

Is the range of angles represented by my sample common or expected and would they normally be expected to mate satisfactorily with female fittings that might exhibit a similar variability?

Any experience that you might care to share will be gratefully received.

Mike

Hello,

I realize that this is an oldish thread and that the OP may not be around any more, but I think my comments below may still be relevant as general ones.

Luer tapers (ISO 594-1) are not formally defined in terms of slope %. Although the Luer taper is termed as a "6% taper", it's dimensionally defined (including tolerances) through diameters and lengths. A carefull telerance analysis of the various cases could yield the resulting allowed % range, however, to determine whether a given (actual) taper meets the dimensional requirements of the standard, it'd have to be judged by the dimensions specified in the standard, not by the slope % alone.

Further, I find that measuring a Luer taper with Vernier calipers, for formal purposes (such as determining compliance with a standard's requirement), would likely be inappropriate, because (a) taking measurements off a taper is not very reliable this way, especially when the diameter is specified at a certain location along the taper; (b) The real precision of most Vernier calipers would not suffice; and (c) the gauge R&R rating of such measurement would most likely be too low.

Theoretically, any combination of an ISO 594-1 compliant male Luer tip and an ISO 594-1 compliant female Luer bore would not bottom out before a secure connection is achieved (I refer to "secure" as meaning "meeting all functional / performance requirements specified in the standard"). However, construction materials of both fittings, and the presence of any use liquids / contamination (serving as lubricants), have a significant bearing on the actual axial travel under a given engagement force. As noted in another post, the common use of semi-rigid (viscoelastic) materials such as PE and PP complicates the theoretical analysis and takes it beyond a simple dimensional analysis that may have sufficed for steel (such materials also introduce time dependency). It's also true, and not uncommon through the industry, that fittings not meeting the standard's dimensional requirements do meet its functional / performance ones.

Cheers,
Ronen.
 
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Wayne

Gage Crib Worldwide
Ronen;
Your post was extremely well worded and displays an intimate understanding of Luer Connectors. You have my respect.
Wayne
 

Ronen E

Problem Solver
Moderator
Ronen;
Your post was extremely well worded and displays an intimate understanding of Luer Connectors. You have my respect.
Wayne

...And vice versa. Members of the Luer Order recognize each other on sight!... :lol:

Cheers,
Ronen.
 
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Pat McGhie

Wayne, I am having a problem locating sources to purchase Luer gages from. The last time we bought, that source is no longer available and a quick Google search is returning tons of fittings but so far no gages.

Can you or anyone else on the Cove provide me some sources?

Thanks to all!

Pat in NH
 

Wayne

Gage Crib Worldwide
I am having a problem locating sources to purchase Luer gages from. … Can you or anyone else on the Cove provide me some sources?
Pat;

I can provide the source you request, :cool: but first let us discuss exactly your requirements. :agree1:

I assume that you desire to check Luer per ISO 594/1 and/or ISO 594/2 and not the obsolete ANSI/HIMA MD70.1. If you are still making product per ANSI/HIMA MD70.1 you are going to have trouble finding gages for that obsolete specification. Click here to read more on ANSI/HIMA MD70.1.

Moving on to the current specification ISO 594/1, I assume that you have copies of ISO 594 and ISO 594/2. If you do not have copies of the standards, buy them. :read: They are inexpensive as standards go and they contain all the instructions for testing the Luer fittings. If you need a source for the standard, here is a page which lists several options for Authorized Resellers of standards.

… a quick Google search is returning tons of fittings but so far no gages.
When you say that you find tons of fittings, I assume that you are speaking of Luer product fittings for end user use. I desire to clear this question because Luer connections are tested by using a combination of Gages and Reference Fittings.

Looking in ISO 594/1 you will find three gages listed: Fig 3a; Fig 3b; and Fig 3c. You will also find two reference fittings listed: Fig 4 and Fig 5. In ISO 594/2 you will only find four Reference Fittings: Fig 5; Fig 6; Fig 7 and Fig 8. These are the measurement tools you will need to evaluate the Luer connection. :caution: Because of the difficulties of measuring Luer Product Fittings, as stated in previous post by Ronen E, the three ISO 594/1 gages are only part of the measurement requirements.
 

Wayne

Gage Crib Worldwide
Can you or anyone else on the Cove provide me some sources?
Pat;

In keeping with the rules of The Cove, I try not to be blatantly self-promoting; however, since you ask directly, the company I work for sells ISO 594 Gages and Reference Fittings.

For product information go to these web pages:
ISO 594/1
ISO-594-2

Marc;
I put this in a separate post to make it easy for you to remove is you deem it necessary.

Wayne
 
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