Medical Connector Conical Plug Gauge

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We offer Conical Plug Gages for the following specifications:
ISO 594-1
ISO 80369-2 (soon to be offered)
ISO 80369-3
ISO 80369-6
ISO 80369-7 (not identical to ISO 594)

ISO-80369 CONICAL PLUG GAGE FOR FEMALE MEDICAL LUER CONNECTORS

ISO 80369-7:2016 cancels and replaces the first edition ISO 594-1:1986 and the second edition of ISO 594-2:1998, clauses, subclauses, tables, figures, and annexes of which have been consolidated and technically revised. The new ISO 80369-7 specification does not define any gauges.

ISO-80369 Family of Specifications
The ISO-80369 family of specifications includes several non-interconnectable connectors used for specific purposes. The conical plug gauges we offer are designed to test the physical size and conical surface of the female conical connector as defined in Annex B of the identified specification. In use, the conical plug gage will identify violations of the MMC (Maximum Material Condition) of the female conical connector. The conical plug gage will ignore violations of the LMC (Least Material Condition) which is why these are not useful for validating full compliance with ISO 80369. They are useful for monitoring production or incoming products because any damage or wear to the production tooling will be evident by changes of the MMC.

ISO 80369-7 Only Defines Reference Connectors.
The authors of the ISO 80369 specification series thought that direct measurement and functional testing was the best ways to establish when a product meets the operational criteria of the specification. We agree that direct measurement and functional testing are excellent methods of validating compliance to the ISO 80369 specifications; however, we also know that these methods are is time-consuming and expensive. Because of the effort required for direct measurement and functional testing; these methods are usually only conducted for: New product approval; New tooling validation; Repaired tooling validation; and Periodic/annual validation of tooling.

So Do I Still Need Conical Ring or Conical Plug Gages?
While the authors of ISO 594/1 included Ring and Plug Gages in the specification; the authors of the ISO 80369 specification series decided to not include the physical testing conical gauges. This does not mean that the tapered plug and ring gages have no usefulness. Appropriate uses for the conical ring and plug gauges still exist and include: incoming material inspection and in-process production control. The ISO 80369 specified functional tests are not useful for monitoring fitting acceptance during manufacturing or spot-checking fittings at incoming receiving. These two operations require the fast and inexpensive testing accomplished only with conical ring and plug gages.

Since ISO 80369-7 has no gages; what can I use?
The good news here is that we offer conical gages designed following the design example of the ISO 594 gages. These gages test the conical surface MMC (Maximum Material Condition) and ignore any issues related to the LMC (Least Material Condition). Ignoring the LMC is acceptable for testing validated parts because any wear or damage to the mold or tooling will cause changes to the MMC, and the conical gage will find the change.

With Or Without 5 Newton Weight?
Luer Plug Gage without 5 Newton weight Luer Plug Gage with 5 Newton Weight

With Or Without 5 Newton Weight?
This is an internal decision for you to make.
We recommend with the 5 Newton weight because:
1. The historical best practice (initiated in ISO 594/1) demands that the conical plug gauge be applied to the part with a force of 5 Newtons.
2. Application of the 5 Newton force is an inaccurate cumbersome operation if the 5 Newton weight is not integral to the conical plug gauge.
3. The test results can easily be falsified or skewed depending on how much unregulated force is applied to the conical plug gauge.
4. If you desire repeatable results from the conical plug gauge, then select the 5-Newton weighted conical plug gage.
Follow this link if you wish a more in-depth discussion on the 5 Newton force.

How to Apply 5 Newton Force
I cannot make this decision for you, but I will supply you with some thoughts about this topic for discussion. What ever you decide you need to support logically to whomever requests your reasoning for your method.

The 5 Newton weight (approximately 18 ounces/510 grams) could be considered a 'light' weight. Neither ISO 594/1 nor ISO 594/2 apply a tolerance to the 5N force. Since there is no tolerance defined; we have considered the 5 Newton force as a nominal value and have applied a conservative tolerance to that. We have converted the 5 Newton force to grams; we use 509.86 grams +/- 0.75 grams.

What is a conservative Tolerance?
There is a 10% Tolerance Rule common in industry which basically uses 10% of the product specification as the tolerance. If we apply 10% of the 5 Newton weight as tolerance (5N+/-0.25N) we should have a conservative tolerance. There are many variables in the application of the 5 Newton force which can be controlled, but are illogical to control because of the expense involved in maintaining that control compared to the benefit of such stringent control. If this is the direction you wish to travel in using the ISO 80369-7 (ISO 594/1 Fig 3c) Luer Plug Gage; we offer it with 5 Newton total weight.

How Do I Use the Luer Plug Gage?
Since ISO 80369 gives no guidance for the use of the Luer Plug Gauge; we revert to the earlier requirements identified in ISO 594/1 to learn the historical best practices..

Procedure for using the Luer Plug Gage
The following data is extracted from ISO 594/1 and expanded for further clarification.

5.1 Gauging Test: The procedure shall be carried out as specified below in 5.1.1 to 5.1.4.

5.1.1 Carry out the test using corrosion resistant steel gauge as illustrated in ISO 594/1 Figure 3c.

5.1.2 Carry out the test at a temperature of 20°C +/-5°C.

5.1.3 Prior to testing, condition products made from hygroscopic materials at 20°C +/-5°C and 50% +/-10% relative humidity for not less than 24 hours. Conditioning is not required for products made from non-hygroscopic materials.

5.1.4 Apply the Luer Plug Gage to the conical fitting with a total axial force of 5 Newtons (see discussion below), without the use of torque. Remove the axial load.

4.1.2 Gauging test results:

a. The plane of the maximum diameter at the opening of the female conical fitting shall lie between the two limit planes on the Luer Plug Gauge.

b. Rocking shall not be evident between the Luer Plug Gage and rigid material fitting undergoing test. This test for freedom from rocking may also be found useful (not required) for evaluating semi-rigid fittings.

General Construction Data:
The Medi-Luer gage product-contact-portions are made of 440C Stainless Steel and hardened to Rockwell C-scale: 56 to 58. The weighted portion made of 303 Stainless Steel. The handle of the non-weighted version is made of Aluminum and is AGD Taperlock Handle #00 size, The use of hardened steel for gages is is not a requirement of any specification; however, we consider it best-practice to use hardened materials for gages so that you have the most reliable inspection tool. If you must have this data certified; this is considered a special request. There will be an extra cost and the lead-time for the gage may double.

Disclaimer:
This data is provided for general information only. The intention is to provide accurate information; regardless; errors may exist in the supplied information. If accuracy is critical, base your final decisions on the data provided in the root documents: ISO594/1:1986; ISO 594/2:1998 and ISO80369-7:2016; which are copyrighted documents. To purchase copies visit an Authorized Reseller.

Comments:
Original Posting: 9/9/2014
Last Revision: 4/30/2017
Error corrections in, or comments about, the above data can be sent to: office@gagecrib.com

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Gage Crib Worldwide, Inc.
6701 Old 28th St SE, Suite B
Grand Rapids, MI 49546-6937
Phone: 001-616-954-6581 • Fax: 001-616-954-6583
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