Ring & Plug Thread Gages  
 
Call 616 954 6581 for Thread Gages
About Ring & Plug Thread GagesUsed - Surplus Ring & Plug Thread GagesRing & Plug Thread Gage Technical InformationRing & Plug Thread Gage CatalogsContact Ring & Plug Thread GagesBookmark

 

 

 

 

Changes From ISO 594 to ISO 80369-7



 

 

Changes Made From ISO 594 to ISO 80369-7
 
Overly simplified...
ISO 594 specification was replaced with ISO 80369-7 in 2016.
The old numbers: ISO 594/1 and ISO 594/2; have been replaced with: ISO80369-7.
The specification for Needle and Syringe connections is now: ISO 80369-7.
Testing of ISO 594 designed connectors should be conducted using ISO 80369-7 testing parameters.
 
Officially…
ISO 80369-7:2016 Foreword states: "ISO 80369-7 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."
 
Overview…
The new ISO 80369-7 is essentially a clerical change from the previous ISO 594. This was to allow the Needle and Syringe Luer Connectors to be included under the ISO-80369 Non-Interconnectable Small-Bore Connector collection of specifications. ISO 80369 is where you find the patient side connectors for various disciplines/families of connections.
• The text has been harmonized to the ISO 80369 Medical Small-Bore Connector specification format.
• The defined connectors have been more clearly dimensioned.
• The testing parameters have been narrowed.
 
Summary...
I believe the intent of the authors of ISO 80369-7 was to allow ISO 594 connectors to be 100% forward compatible with ISO 80369-7. I am 99.9% confident that any ISO 594 designed/tested connector which has passed ISO 594 measurement/testing will pass when measured/tested using the ISO 80369-7 parameters; the opposite statement is not true.
 
Some Specific Changes...
 
ISO 80369-7:2016 Foreword, a)
New terms and definitions have been added to this part of ISO 80369 to more clearly define the various types of Luer connectors included in the scope of this part of ISO 80369. This part of ISO 80369 more broadly describes the requirements for the connectors used for intravascular or hypodermic applications, unlike ISO 594-1 and ISO 594-2 that are replaced by this part of ISO 80369, which only described the requirements for the fittings (intended connection surfaces) of these connectors. This distinction is important to define here because the previous International Standards do not contain the terms connector or connection and ISO 80369 series does not use the term fitting.
 
Editorial comment: This is a semantics issue. It is no big deal so just go with it. Stop using the term fitting and start using the terms connector or connection.
 
ISO 80369-7:2016 Foreword, b)
Requirements for certain dimensions not previously identified in ISO 594-1 and ISO 594-2 are added to this part of ISO 80369 to reduce the risk of misconnections between medical devices or accessories for different applications with the small-bore connectors that are being developed under other parts of the ISO 80369- series. These new dimensions were selected to represent the current design and dimensions of Luer connectors in clinical use at the time this part of ISO 80369 was developed. The term “6% (Luer) taper” used throughout the previous standards has also been clarified to the more commonly used equivalent specified diameters separated by a specified distance on a common axis.
 
ISO 80369-7:2016 Foreword, b)
Requirements for gauging of Luer connectors made from semi-rigid materials using plug and ring test gauges have been replaced by dimensional requirements, which are more precise and essential for reducing the risk of misconnection with the other connectors identified in ISO 80369-1.
 
Editorial comment: We agree that gauging should not be used for official part validation, but the conical plug and ring test gauges still have purpose; specifically, for in-process testing and incoming materials validation.
We offer extra-specification ISO 80369-7 Gages for in-process testing and incoming materials validation.
 

ISO 80369-7:2016 Foreword, d)
Separate requirements for Luer connectors made from semi-rigid materials and rigid materials have been eliminated and combined as one common set of dimensions and requirements. This consolidation of requirements was made to further reduce the risk of misconnection with other small-bore connectors.

 
Editorial comment: This decision to not delineate separate requirements for semi-rigid and rigid materials has been reversed and is reinstated in the 2021 second edition of ISO 80369-7.
 
Annex B Changes
 
Editorial comments:
1. The HIMA MD70.1 Luer product medical small bore connector cones are identical in size to ISO 594 Luer product medical small bore connector cones.
2. The ISO 594 Luer product medical small bore connector cones fit within the ISO 80369-7 Luer product medical connector cone sizes. This means that tooling designed to make ISO 594 Luer product medical small bore connector cones will produce parts which fit within the ISO 80369-7 Luer product medical small bore connector cone design parameters.
 
Figure B.1 Dimension Changes
1. The ISO 594 ‘d’ & ‘g’ features are differentiated for Semi-Rigid and Rigid.
2. The 2016 ‘d’ & ‘g’ features do not have differentiation for Semi-Rigid and Rigid.
(NOTE: The Rigid version has returned in the 2021 second edition.)
3. The 2016 Minimum ‘g’ feature for Semi-Rigid is 0.002mm (0.00008”) larger than ISO 594* ‘g’ Semi-Rigid feature. This difference is so minimal that it is insignificant and likely attributable to a difference in rounding parameters.
B.1  
ISO 594*
2016
Dimension
Minimum
Maximum
Minimum
Maximum
Semi-Rigid Diameter d
3.970
4.072
3.970
4.072
Rigid Diameter d
3.970
4.035
Semi-Rigid Diameter g
4.374
4.476
4.376
4.476
Rigid Diameter g
4.374
4.439
*The ISO 594 values have been adjusted mathematically so the numbers relate to the
ISO 80369-7 measurement points.
 
Annex C Changes
 

ISO 594/1 Reference Connectors
The ISO 594/1 Figure 4 and 5 Reference Connectors have been changed in ISO 80369-7 Annex C.

ISO 594/1 Fig 4 has been redesignated ISO 80369-7 Fig C.5. Figure 4 is not forward compatible. Figure C.5 is backward compatible.

ISO 594/1 Fig 5 has been redesignated ISO 80369-7 Fig C.2. Figure 5 is not forward compatible. Figure C.2 is backward compatible.

The ISO 594/1 Fig 4 and 5 specified 7.5 min conical length has been changed to 10.5 min in ISO 80369-7 Fig C.2 and C.5. This change is why the ISO 594/1 Fig 4 and 5 Reference Connectors are not forward compatible to ISO 80369-7. If you need to test Luer slip you need to obtain new ISO 80369-7 Reference Connectors.

The ISO 594/1 Fig 4 and 5 illustrated a radius at the working end of the cone but did not apply a size. ISO 80369-7 Fig C.2 and C.5 assigned 0.5 as the max radius size.

We offer ISO 80369-7 Annex C Reference Connectors for sale which can be used for functional testing.

 

ISO 594/2 Reference Connectors
ISO 594/2 Fig 5, 6, 7 and 8 Reference Connectors have been carried forward virtually unchanged into ISO 80369-7 Annex C.ISO 594/1

ISO 594/2 Fig 5 has been redesignated ISO 80369-7 Fig C.1. ISO 594 Fig 5 is identical to 80369-7 Fig C.1 except that ISO 80369-7 Fig C.1 is more fully dimensioned. ISO 594/2 Fig 5 is forward compatible. ISO 80369-7 Fig C.1 is backward compatible.

ISO 594/2 Fig 6 has been redesignated ISO 80369-7 Fig C.3. ISO 594 Fig 6 is identical to 80369-7 Fig C.3 except that ISO 80369-7 Fig C.3 is more fully dimensioned. ISO 594/2 Fig 6 is forward compatible. ISO 80369-7 Fig C.3 is backward compatible.

ISO 594/2 Fig 7 has been redesignated ISO 80369-7 Fig C.4. ISO 594 Fig 7 is identical to 80369-7 Fig C.4 except that ISO 80369-7 Fig C.4 is more fully dimensioned. ISO 594/2 Fig 7 is forward compatible. ISO 80369-7 Fig C.4 is backward compatible.

ISO 594/2 Fig 8 has been redesignated ISO 80369-7 Fig C.6. ISO 594 Fig 8 is identical to 80369-7 Fig C.6 except that ISO 80369-7 Fig C.6 is more fully dimensioned. ISO 594/2 Fig 8 is forward compatible. ISO 80369-7 Fig C.6 is backward compatible.

We offer ISO 80369-7 Annex C Reference Connectors for sale which can be used for functional testing.

 

ISO 80369-7 Reference Connectors
ISO 80369-7 Annex C specifies the Reference Connectors to be used to functionally test Annex B Connectors.

We offer ISO 80369-7 Annex C Reference Connectors for sale which can be used for functional testing.

 
ISO 80369-7 Test Methodology
ISO 80369-7 Clause 6 defines the test requirements, and points to ISO 80369-20 where the test methodology is defined.
 
Notice:
This website is funded by the sale of screw thread measurement tools. It will help us continue to offer this data if you allow us to have the opportunity to sell our tools to your company. If you find this information useful, please work to get Gage Crib Worldwide Inc. on the bid list for future purchases of medical small bore connector measurement tools.
 
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 document: ISO80369-7:2016; which is a copyrighted document. To purchase a copy visit an Authorized Reseller.
 

Comments:
Original Posting: 6/4/2021
Last Revision: 7/13/2021
Error corrections in, or comments about, the above data can be sent to: office@gagecrib.com

 

 

 

About UsUsed SurplusTech InfoCatalogsContact UsBookmark
 

 

Top

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
CONTACT  FORMS & INFO

Copyright © 2002-2019 Ring & Plug Thread Gages. All rights reserved.