Changes Made From ISO 80369-7:2016 to ISO 80369-7:2021
Overly simplified...
The first edition of ISO 80369-7 specification was replaced with the second edition in 2021.
Note:
Standard-practice is to refer (on drawings and in conversation) to the specification without a date-identifier. The intent in this standard-practice is that the current version is used exclusively; supplanting the older versions. The date-identifier should only be referenced when the old version data is mission critical. On this page, because we are comparing the first and second edition, for clear communication we must refer to the date-identifiers.
The specification for Luer Needle and Syringe connections is still: ISO 80369-7. Testing of HIMA MD70.1 designed connectors should be conducted using ISO 80369-7:2021 testing parameters.
Testing of ISO 594 designed connectors should be conducted using ISO 80369-7:2021 testing parameters.
Testing of ISO 80369-7:2016 connectors should be conducted using ISO 80369-7:2021 testing parameters.
Officially… ISO 80369-7:2021 Foreword states: "This second edition cancels and replaces the first edition (ISO 80369-7:2016), which has been technically revised."
Overview…
The main changes compared to the previous edition are as follows:
• Annex B semi-rigid & rigid materials separated.
• Figure B.3 & B.4 t-dimension made auxiliary.
• Figure B.6 N1 & N2 dimensions changed.
• Annex C Reference Connector changes.
Summary...
The specification was improved through some small changes to correct some issues raised by users of the specification. Efforts were made to minimize any negative repercussions resulting from the changes.
Annex B semi-rigid materials and rigid materials separated.
Some requirements for Luer connectors have been separated for semi-rigid materials and rigid materials to better ensure compatibility at the extreme of the design space. Definitions of semi-rigid material and rigid material have been added.
Editorial Comment on Annex B Design Changes:
Addition of Rigid Design
The Rigid design is virtually identical to ISO 594 and the initial MD70.1. This second edition of ISO 80369-7 should be used exclusively for new Rigid designs and existing Rigid designs only need a clerical change of the specification number.
Addition of Recommended Semi-Rigid Design
The Recommended Semi-Rigid design returns the ISO 594 minimum design values to two features but does not give the rationale for this recommendation.
Figure B.1 Dimension Changes
1. The 2016 ‘d’ & ‘g’ features did not have differentiation for Semi-Rigid and Rigid.
2. The 2021 ‘d’ & ‘g’ features are differentiated for Semi-Rigid and Rigid.
3. The 2021 Minimum ‘d’ feature for Rigid matches the 2021 ‘d’ Semi-Rigid feature.
4. The 2021 Maximum ‘d’ feature for Rigid is 0.037 less than the 2021 ‘d’ Semi-Rigid feature.
5. The 2021 Minimum ‘g’ feature for Semi-Rigid is 0.001mm (0.00004”) less than 2016.
6. The 2021 Maximum ‘g’ feature for Semi-Rigid is 0.001mm (0.00004”) larger than 2016.
7. The 2021 ‘g’ feature Semi-Rigid change is fully backward compatible with 2016 first edition requirements.
8. The 2021 Minimum ‘g’ feature for Rigid matches the 2021 ‘g’ Semi-Rigid feature.
9. The 2021 Maximum ‘g’ feature for Rigid is 0.037 less than the 2021 ‘g’ Semi-Rigid feature.
B.1
2016
2021
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
4.376
4.476
4.375
4.477
Rigid Diameter g
4.375
4.440
Figure B.2 Dimension Changes
1. The 2016 ‘D’ & ‘G’ features did not have differentiation for Semi-Rigid and Rigid.
2. The 2021 ‘D’ & ‘G’ features have Recommended Semi-Rigid minimum values.
3. The 2021 ‘D’ feature Recommended Semi-Rigid minimum value matches the ISO 594* feature size.
4. The 2021 ‘G’ feature Recommended Semi-Rigid minimum value is 0.001mm (0.00004”) less than the ISO 594* value.
5. The 2021 ‘D’ & ‘G’ features are differentiated for Semi-Rigid and Rigid.
6. The 2021 Minimum ‘D’ feature for Rigid is 0.027 larger than the 2021 ‘D’ Semi-Rigid feature.
7. The 2021 Minimum ‘D’ feature for Rigid matches the ISO 594* value.
8. The 2021 Maximum ‘D’ feature for Rigid matches the 2021 ‘D’ Semi-Rigid feature.
9. The 2021 Maximum ‘D’ feature for Rigid matches the ISO 594* value.
10. The 2021 Minimum ‘G’ feature for Rigid is 0.027 larger than the 2021 ‘G’ Semi-Rigid feature.
10. The 2021 Minimum ‘G’ feature for Rigid is 0.001mm (0.00004”) less than the ISO 594* value.
11. The 2021 Maximum ‘G’ feature for Rigid is 0.028 less than the 2021 ‘G’ Semi-Rigid feature.
12. The 2021 Maximum ‘G’ feature for Rigid is 0.001mm (0.00004”) less than the ISO 594* value.
B.2
ISO 594*
2016
2021
Dimension
Minimum
Maximum
Minimum
Maximum
Minimum
Maximum
Semi-Rigid Diameter D
4.225
4.270
4.198
4.298
4.198
4.298
Recommended Variant for Semi-Rigid Diameter D
4.225
4.298
Rigid Diameter D
4.225
4.270
4.225
4.270
Semi-Rigid Diameter G
3.821
3.866
3.793
3.893
3.793
3.893
Recommended Variant for Semi-Rigid Diameter G
3.820
3.893
Rigid Diameter G
3.821
3.866
3.820
3.865
*The ISO 594 values have been adjusted mathematically so the numbers relate to the ISO 80369-7 measurement points.
Figure B.3 & B.4 t-Dimension Made Auxiliary
The distance from the cone tip of the Figure B.3 and B.4 connector to the bottom of the first complete thread profile of the internal thread (t dimension) has been made an auxiliary dimension due to the difficulty in its measurement. The functional impact of the dimension is evaluated with the Clause 6.4 Resistance to Separation from Axial Load functional test.
Figure B.6 N1 & N2 dimensions changed.
Short explanation of the change: The Figure B.6 N1 and N2 dimensions of the female Luer lock connector variant A (with lugs at right angle to axis) have been changed to allow measurement from the open end of the connector, to better ensure compatibility at the extreme of the design space.
Editorial comment:
Note that the that N values could be at max tolerance in 2016 with a max tolerance Q offset at 0.3. Thus, while actual N value maximum dimension are same in 2016 and 2021, the tolerance change may make parts which complied to ISO 80369-7:2016 fall out-of-tolerance according to the now current ISO 80369-7:2021 version.
Specific changes made to the ‘N1’ feature:
1. The 2016 ‘N’ feature designation was changed to ‘N1’ in the 2021 version.
2. The 2016 ‘N’ feature designation read: Width of the lug profile at the root at a diameter corresponding to 6,730 on the leading end of the lug as it is screwed into a male connector.
3. The 2021 ‘N1’ feature designation reads: Distance from the face of the connector to the leading end of the lug as it is screwed into the male connector at a diameter corresponding to 6,730.
4. The 2016 ‘N’ Maximum Dimensions are unchanged for ‘N1’ in the 2021 second edition.
5. The 2021 ‘N1’ does not list the Minimum or Nominal Dimensions. These dimensions have been removed.
Specific changes made to the ‘N2’ feature:
1. The 2016 ‘N2’ feature designation read: Width of the lug profile at the root at a diameter corresponding to 6,730 on the trailing end of the lug as it is screwed into a male connector.
2. The 2021 ‘N2’ feature designation reads: Distance from the face of the connector to the trailing end of the lug as it is screwed into the male connector at a diameter corresponding to 6,730.
3. The 2016 ‘N2’ Maximum Dimension is unchanged in the 2021 second edition.
4. The 2021 ‘N2’ does not list the Minimum or Nominal Dimensions. These dimensions have been removed.
Specific changes made to the ‘Q’ feature:
1. The 2016 ‘Q’ Maximum Dimension is unchanged in the 2021 second edition.
2. The 2021 ‘Q’ does not list the Minimum or Nominal Dimensions. These dimensions have been removed.
B.6
2016
2021
Dimension
Minimum
Maximum
Minimum
Maximum
N1
(0.533)
1.200
---
1.200
N2
---
2.070
---
2.070
N1
Width of the lug profile at the root at a diameter corresponding to 6,730 on the leading end of the lug as it is screwed into a male connector.
Distance from the face of the connector to the leading end of the lug as it is screwed into the male connector at a diameter corresponding to 6,730.
N2
Width of the lug profile at the root at a diameter corresponding to 6,730 on the trailing end of the lug as it is screwed into a male connector.
Distance from the face of the connector to the trailing end of the lug as it is screwed into the male connector at a diameter corresponding to 6,730.
Q
0.000
0.300
---
0.300
Annex C Reference Connector Changes.
There have been several changes to the Reference Connectors:
• Annex C cone dimensional change.
• Annex C cone proximal radius change.
• Annex C tolerances increased.
Are 2016 Reference Connectors still usable?
Short Answer: YES.
Long Answer: For those concerned that these changes will mandate replacement of Reference Connectors made to the ISO 80369-7:2016 designs; never fear! The authors have saved you.
ISO 80369-7:2021, Clause C.1, NOTE
"Reference connectors made to the tolerances of Annex C of ISO 80369-7:2016 are considered to conform to the following figures." (Typically, a note like this will be removed when the specification is next revised.)
My Suggestion:
When you next calibrate your ISO 80369-7:2016 Reference Connectors; use the ISO 80369-7:2021 design standard. When the 2016 Reference Connector passes the 2021 requirements; you know it meets the current requirements. If it fails the 2021 criteria, only then invoke the 'NOTE' and utilize the 2016 dimensions. The 2016 dimensions must be used to calibrate that specific Reference Connector until it is retired. The chance that a 2016 Reference Connector will fail 2021 criteria is slim. Most of the changes make the tolerances more generous. The possibility of calibration failure but it is extremely unlikely.
Annex C Reference Connector Changes:
Annex C Cone Dimensional Change (all figures):
Dimension
2016
2021
2016 Female Cone LE Diameter @ 0
4.292+0/-0.005
---
2021 Female Cone LE Diameter @ 0.75
---
4.247+0.001/-0.004
Female Conical Angle calculated using nominal sizes.
3.437°
3.436°
2016 Male Cone SE Diameter @ 0
3.976+0/-0.005
---
2021 Male Cone SE Diameter @0.75
---
4.021+0.001/-0.004
Male Conical Angle calculated using nominal sizes.
3.436°
3.437°
Summary Evaluation of Conical Dimension Changes:
This is the place where a 2016 Reference Connector may fail 2021 criteria. This change is not announced in ISO 80369-7:2021, but it is there. I estimate that 1% of the 2016 Reference Connectors may fail because of this change. Hopefully your 2016 Reference Connectors are made to the dimensional mean. If that is so, this change will cause no pain. Regardless; if your 2016 Reference Connector fails because of this, use the ISO 80369-7:2021, Clause C.1, NOTE as your escape clause.
Discussion of Conical Dimension Changes:
I know the change looks confusing, but it is not so bad.
The location of the specified diameter at the proximal end of the cones was changed. This is the LE (Large End) diameter of the female cone and the SE (Small End) diameter of the male cone. In the 2016 specification the conical proximal-end diameter gauge point is located at the proximal end of the cone. In the 2021 specification the conical proximal-end diameter gauge point was established at 0.75mm along the conical axis toward the distal end of the cone. The conical diameter was recalculated for the new point. This meets the best-practice for dimensioning a conical surface.
Best-Practice to Dimension Conical Surface:
The best-practice for establishing a diametrical value to a conical surface is to place the value at a fixed point along the conical axis. Commonly we see cones dimensioned with the diametrical value at the LE or SE of the cone. This poor practice makes it easy to design the cone but requires the use of complicated math for anyone trying to measure the cone. The best-practice is more difficult for the engineer (one person trained in math) during the design process but simplifies the subsequent validation of the conical surface for everyone else. Changing the position of the measurement was wise because the diametrical value can now be directly measured and thus clearly certified. The previous location for the diametrical value was at a theoretical sharp corner, which was nonexistent because the radius removed the exact sharp corner diameter; all certifications were an extrapolated value based on math.
So far so good, a perfect change, but they also changed the tolerance.
Best-Practice to Tolerance Conical Surface:
The best-practice for tolerance for a cone is to have the tolerance be unidirectional in opposite directions on opposite ends of the cone. In 2016 the proximal end of cone had +0/-0.005 tolerance, but in 2021 the tolerance for the proximal end of the cone was changed to +0.001/-0.004. The effect is to slightly adjust the conical angle, which may have been necessary. My opinion is that it would have been better to have changed the diametrical value by the 0.001 and kept the best-practice tolerance paradigm.
Annex C Cone Proximal Radius Change
Dimension
2016
2021
Radius at Large End of Female Cone
equal to or less than R0.5
R
Radius at Small End of Male Cone
equal to or less than R0.5
R
Discussion of Conical Dimension Changes:
The 2016 Radius had a generous tolerance, so it should not have been a problem to manufacture, but I expect that it was somewhat cumbersome to calibrate. Since the radius has no functional value for creating a leak-free connector, I think the tolerance was removed so that it could not be certified. In 2016 it was permissible to manufacture a reference connector without a radius, but in 2021 a radius must be evident. The only important thing is that a radius exists, but no one cares about its size. A logical manufacturer will keep the radius at a minimum size because it takes less effort to make. With no size specified, it could be permissible to make a radius greater than 0.75mm; but that would remove the calibration surface for the proximal end conical diameter; so, I do not expect anyone will make the radius that large.
Annex C Tolerances Increased
ISO 80369-7:2021 Forward states: "Tolerances of several reference connector dimensions are increased to facilitate easier manufacturing and certification. Most of the affected tolerances are for features that do not contact the test connector and therefore do not affect the test results. The angle tolerance for the bearing side of the threads do contact the connector under test but the change in the tolerance is considered likely have minimal to no effect on test outcomes."
Exactly What Was Changed? All the tolerance changes have an unchanged nominal value and an increased tolerance. This means that all 2016 versions will pass 2021 criteria. The specific changes are listed below.
Figure C.1 Reference Connector Changes
Dimension
2016
2021
3.5 Tab Width
+0/-0.01
+0/-0.025
25° Tab Front Flank
+0.07°/-0°
+5°/-5°
25° Tab Back Flank
+0.07°/-0°
+2°/-0°
6.73 Minor Diameter of Tab
+0/-0.01
+0/-0.05
Figure C.3 Reference Connector Changes
Dimension
2016
2021
2.71 Tab Width
+0/-0.01
+0/-0.025
25° Tab Front Flank
+0.07°/-0°
+5°/-5°
30° Tab Back Flank
+0°/-0.07°
+0°/-0.2°
6.25 Minor Diameter of Tab
+0.01/-0
+0.025/-0.025
Figure C.4 Reference Connector Changes
Dimension
2016
2021
3.2 Distance from Tip of Cone to Back of 1st Full Thread
+0/-0.01
+0/-0.05
2.1 Distance from Tip of Cone to Face of Collar
+0.01/-0
+0.05/-0
25° Thread Front Flank Angle
+0.07°/-0°
+5°/-0°
25° Thread Back Flank Angle
+0.07°/-0°
+2°/-0°
7.9 Major Diameter of Thread
+0.02/-0
+0.05/-0
Figure C.6 Reference Connector Changes
Dimension
2016
2021
3.2 Distance from Tip of Cone to Back of 1st Full Thread
+0/-0.01
+0/-0.05
2.1 Distance from Tip of Cone to Face of Collar
+0.01/-0
+0.05/-0
7.5 Distance from Tip of Cone to Bottom of Thread
+0/-0.01
+0.1/-0.01
30° Thread Front Flank Angle
+0°/-0.07°
+0°/-5°
30° Thread Back Flank Angle
+0°/-0.07°
+0°/-5°
8 Major Diameter of Thread
+0.02/-0
+0.025/-0.025
Notice:
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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: 12/9/2022
Error corrections in, or comments about, the above data can be sent to: office@gagecrib.com
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