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ISO 594 Conical Plug Gauge for Female Luer Connector

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

We also offer:
- DUO-Remarking/DUO-Recertification Service (ISO-80369-7 and ISO 594) for existing ISO 594 Gages and Reference Connectors


ISO 594 Has Been Replaced
ISO 80369-7 Foreword

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.

We still offer the ISO 594 Conical Plug Gages
Understanding that some companies may desire to test select parts against the obsolete ISO 594 specification; we have continued to make available the ISO 594/1 conical gages.

ISO 594 Gages Can Be Used For ISO 80369-7 Connectors
The ISO 594-1 Gauges can be used to test ISO 80369-7 parts; however, in doing so you are giving up some of the ISO 80369-7 product tolerance. ISO 80369-7 Connectors which pass testing with ISO 594/1 conical gages will pass testing with gages designed for ISO 80369-7; however, connectors which pass testing with gages designed for ISO 80369-7 may fail testing when tested with ISO 594-1 conical gages. The authors of ISO 80369-7 have made slight changes to the Luer cones which slightly increased their size. The ISO 594 Luer cones fall within the sizes of the ISO 80369-7 cones so that they are completely backward compatible.

We Include DUO-Marking and DUO-Calibration
The ISO 594/1 Conical Gages we sell will be DUO-marked and DUO-calibrated; unless otherwise requested. We do this because they meet the ISO 594-1 gage design, and because ISO 80369-7 connections which are validated with the ISO 594/2 conical gages will meet the requirements of ISO 80369-7. We also understand that since ISO 80369-7 does not define conical gages, that leaves some flexibility in what could be considered the appropriate size for an ISO 80369-7 conical gage. We think that the ISO 594/1 conical gages are grandfathered into acceptance for testing ISO 80369-7 conical connectors, but for those who wish to move forward to the full size allowed by ISO 80369-7; we also offer gages designed to test the full size of ISO 80369-7 conical connectors; which are not backward compatible with ISO 594-1.

Can I Get My Existing ISO 594-1 Conical Gages DUO-Marked/DUO-Certiried?
Your existing ISO 594/1 Luer Gages may be sent to us. We will DUO-mark and DUO-certify the Luer Gauges and will return it to you. The certification will be by an ISO 17025 Accredited Calibration Laboratory which has Medical Gages and Reference Connectors in their ISO 17025 Scope. The cost of this service to you varies depending on how many gages are processed at one time. The DUO-mark and DUO-certify process will take about 4 weeks to complete.

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. ISO 594/1 demands that the Luer 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 Luer Plug Gage.
3. The test results can easily be falsified or skewed depending on how much unregulated force is applied to the Luer Plug Gauge.
If you desire repeatable results from the Luer Plug Gage, then select the Luer Plug Gauge with the 5 Newton weight.
Follow this link if you wish a more in-depth discussion on the 5 Newton force.

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.

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.

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.

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.

Original Posting: 9/9/2014
Last Revision: 11/6/2017
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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