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ISO-80369-7 Fig C.2 Male Reference Luer Slip Connector
 
 
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ISO 80369-7 FIGURE C.2 MALE REFERENCE LUER SLIP CONNECTOR

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. Because of this, ISO 594 connections must be tested per ISO 80369-7 requirements. Read: Discussion on the change.

Compatibility/Interchangeability Between ISO 594/1 Figure 5 and ISO 80369-7 Figure C.245
The ISO 594/1 Figure 5 Male Reference Conical Fitting is replaced by
ISO 80369-7 Fig C.5 Male Reference Luer Slip Connector. The ISO 80369-7 Figure C.2 is not identical to the ISO 594/1 Figure 5 Reference Fitting, so it cannot be certified as ISO 80369-7 Figure C.2. The good news is that the ISO 80369-7 Figure C.2 Male Reference Luer Slip Connector is backward compatible with the ISO 594/1 Figure 5 Reference Fitting; so it can be certified and used in ISO 594/1 designated testing.

For those who just need to know the full details...
The minimum conical length changed from the ISO 594/1 Figure 5 requirement of 7.5mm minimum; to the ISO 80369-7 Figure C.2 requirement of 10.5mm minimum. I think it is obvious to see that an ISO 80369-7 Figure C.2 Male Reference Luer Slip Connector with a certified minimum length of 10.5 will always meet the ISO 594/1 Figure 5 Male Reference Conical Fitting requirement of 7.5mm minimum.

 
 

Escape Clause:
ISO 80369-7; Page 24; Annex C; Figure C.2; Note 2 states:
The minimum length of the female taper of 10,5 mm is required for testing non-interconnectable characteristics. A minimum length of the female taper of 7,5 mm may be used for the performance tests of Clause 6.
What they are saying here is that if you use an ISO 594/1 Fig 5 Reference Fitting with a certified length of 7.5mm minimum you can use it for all of the tests of ISO 80369-7 Paragraph/Clause 6, but if you sent that Reference fitting out to be certified to match ISO 80369-7 Fig C.2 it will fail because it does not meet the 10.5mm minimum. This escape Clause will allow you to use your old ISO 594/1 Fig 5 Reference Fittings until they wear out or until you cannot convince the oversight party that it is allowed.

From our perspective:
If you request a quote for a new ISO 594/1 Fig 5 Reference Connector from us; we will quote an item which will pass both ISO 594 and ISO 80369-7 requirements. It will be DUO-marked and DUO-certified to both specifications.

 
ISO 80369-7 Fig C.2 Male Reference Luer Slip Connector
The ISO 80369-7 Fig C.2 Male Reference Luer Slip Connector is used for testing Female Luer Connectors for: Leakage; Separation from axial load; Stress cracking; and Non-interconnectable characteristics in the ISO 80369-7; Clause 6 specified tests. Keeping with the requirements of ISO 80369-7; the Reference Connectors we sell are from hardened stainless steel. The ISO 80369-7 Fig C.2 Male Reference Luer Slip Connector has design details which are not specified in ISO 80369-7 and which allow connection to test equipment. These design details vary by manufacturer so be sure you understand the configuration before you order the Reference Connector. The ISO 80369-7 Fig C2 Male Reference Luer Slip Connector is an integral part of Luer needle and syringe testing.
 
Uses for the ISO 80369-7; Page 24; Annex C; Fig C.2; Male Reference Luer Slip Connector
Below is a list of tests which are best accomplished by using the ISO 80369-7 Fig C.4 Male Reference Luer Slip Connector:
ISO 80369-7 Clause...
4.1: Non-Interconnectivity
6.1: Fluid Leakage
6.2: Sub-Atmospheric Pressure Air Leakage
6.3: Stress Cracking
6.4: Resistance To Separation From Axial Load
 
ISO 80369-7; Page 4; Paragraph 6.1.2; Leakage By Pressure Decay 
To conduct this Liquid Leakage Test found in ISO 80369-7 clause 6.1.2 the following Enersol products are required:
S11 - Male Reference Luer Slip Connector ISO 80369-7 Fig C.2
S15A - Connector Assembly Device
S77 - Automated Pressure Decay Tester
 
ISO 80369-7; Page 5; Paragraph 6.1.3; Positive Pressure Liquid Leakage 
To conduct this Liquid Leakage Test found in ISO 80369-7 clause 6.1.3 the following Enersol products are required:
S11 - Male Reference Luer Slip Connector ISO 80369-7 Fig C.2
S15A - Force/Torque Fitting Assembly Machine
S16A - Falling Drop Positive Pressure Liquid Leakage Tester
 
ISO 80369-7; Page 5; Paragraph 6.2; Sub-atmospheric pressure air leakage 
To conduct the Air Leakage Test found in ISO 80369-7 clause 6.2 the following Enersol products are required:
S11 - Male Reference Luer Slip Connector ISO 80369-7 Fig C.2
S15A - Force/Torque Fitting Assembly Machine
S17A - Subatmospheric Pressure Air Leakage Tester
or
S78 - Automated Subatmospheric Pressure Air Leakage Tester
 
ISO 80369-7; Page 5; Paragraph 6.3; Stress Cracking  
To conduct the Stress Cracking Test found in ISO 80369-7 clause 6.3 the following Enersol products are required:
S11 - Male Reference Luer Slip Connector ISO 80369-7 Fig C.2
S15A - Force/Torque Fitting Assembly Machine
 
ISO 80369-7; Page 5; Paragraph 6.4; Resistance to Separation From Axial Load 
To conduct the Separation Force Test found in ISO 80369-7 clause 6.4 the following Enersol products are required:
S11 - Male Reference Luer Slip Connector ISO 80369-7 Fig C.2
S15A - Force/Torque Fitting Assembly Machine
S18 - Separation Force Test Machine
 
ISO 80369-7; Page 3; Paragraph 4.1; Non-Interconnectable Characteristics 
This test is part of the validation process for new connector designs. Since the connectors in ISO 80369-7 have already been developed you should never have to do this test to validate a connector to ISO 80369-7.
 
Price List:
Alamo ISO 80369-7 Reference Connectors
Enersol ISO 80369-7 Reference Connectors
Medi-Luer ISO 80369-7 Reference Connectors
Enersol ISO 80369-20 Test Machines
 

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; ISO80369-7:2016; and ISO80369-20:2014 which are copyrighted documents. To purchase copies visit an Authorized Reseller.

Comments:
Original Posting: 3/20/2009 
Last Revision: 1/10/2017
Error corrections in, or comments about, the above data can be sent to: gageguy@gagecrib.com

 

 

 

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