INTERNATI()NAL ISO

STAr\JDARD 594-2

Second edition
1998-09-01

.;.

Conical fittings with 6 % (Luer) taper for

syringes, needles and certain other medical
equipment -

Lock fittings

Assefllb/ages coniques a 6 % (Luer) des seritujues et aiguil/es

et de certains eutres epotireils a usage medica/-
Partie 2: Assemblages ;1 verroui/lage

r '

ileference number
 594-2:1998(E)

Contents Page
: ,~>

1 Scope ' 1

2 Normative references /':(, 1

3 Dimensions and tolerances 1

I

4 P·q'"':'..·:~·"'lo~·~·!1ts
.."' _.' ::' ~ .._.;._.~ , '.: ..-.. _~ _ : , __ .

5 Test rnethods 6

';J ISO 1998

'" rights reserved. Unless otherwise spectlied, no part of this publication may be reproduced or utilized in any torrn or by arty means. electronic
or mecnanical. including photocopying and microfilm. without permission in writing from the publisher.
international Organization tor Standardization
Case costate 56 • CH·1211 Gilneve 20 • Switzerland
.nternat [email protected]
.Jrinted in Switzertand
 ISO 594-2:19981

Foreword

ISO (tho International Organization for Standardization) is a worldwide Iederation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the Iiqht to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnica!
Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.

Clr"l! ~n!"HlldliG:la! StdnG:::rjs a.Iopted bv the technical committees d.IG circulateototne rnembe. 0uUi83 for ,ti.-'~~
.,! ..

r"uullcation as dn inicrn8:j<>!;;:;j :-;;;::,.r;;-!;::;:j requires approval by at !(';:dSt75 % of the rnernber bodies C2:~W;j •• ··
•.(;,8.

International Standard ISO 594-2 was prepared by Technical Committee Isonc 84, Medical devices for injections.

This second edition cancels and replaces the first edition (ISO 594-2:1991), of which it constitutes a minor revision .
•
It corresponds to European Standard EN 1707: 1996, prepared by Technical Committee CENffC 205, Non-active
medical devices.

ISO 594 consists of the following parts, under the general title Conical fittings with a 6 % (Luer) taper for syringes,
needles and certain other medical equipment:

Part 1: General specifications

Part 2: Lock fittings

io
 -----------.~ ---
... .. -.

INTERNATIONAL STANDARD © ISO ISO 594-2: 1998(E)

Conical fittings with 6 % (Luer) taper for syringes, needles

and certain other medical equipment - Part 2: Lock tittlnqs

1 Scope

This Dart of ISO 594 specifies requirements for conical lock fittings with a 6 % (Luer) taper for use with hypodermic
syrinqes and needles and with certain other apparatus for medical use, e.g. transfusion equipment.

The requirements apply to fittings made of rigid and of semi-rigid materials and include test methods, but exclude
provision for more flexible or elastomeric materials.

;<~;::::: I !t is no. !"fudic<JbIC IV C!c:lc:;" ~:-;r :~'<!~2ct8ri~:.icsol rigid or se';::-!':gid IT",!erials with precision, bu1 g:038 r\nc; ,;~e(oi may
l;~ considered as typical rigid materials. In contrast many plastics materials may be regarded as semi-rigid.

NOTE 2 The Luer lock fitting was designed for use at pressures of the order of 300 kPa or lower. Its use in other applications
may require consideration to establish its suitability.

2 Normative references

The following normative documents contain provisions which, through reference in this text, constitute provisions of this
part of ISO 594. For dated references, subsequent amendments to, or revisions of, any of these publications do not
apply. However, parties to agreements based on this part of ISO 594 are encouraged to investigate the possibility of
applyinq the most recent editions of the normative documents indicated below. For undated references, the latest
edition of the normative document referred to applies. Members of ISO and lEe maintain registers of currently valid
International Standards. '

ISO 468, Surface roughness - Parameters, their values and general rules for speci(ying requirements.

ISO 594-1: 1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -
Part 1: General requirements.
\
ISO 7886-1, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use.

3 Dimensions and tolerances

1.1 Mole and female 6 % (Luer) conical fittings

Ihe dimensions and tolerances for the male and female fitlings specified in ISO 594-1 apply to the relevant conical part
)f the fitting described in clause 4 of this part of ISO 594.

3.2 Male and female 6 % (Luer) conical lock fittings

.3.2.1 Rigid materials

the dimensions of male and female lock fittings rnade of rigid materials shall be as shown in Figures 1 to 4 and as
jiven in Fable 1.
 "
©ISG

3.2.2 Semi-rigid materials

For fittings made using semi-rigid materials, because of their nature it is not possible to specify the fittings dimensions
accurately. Design and dimensions of fittings ~ of these materials may vary from those designated in Figures 1
and 4 and given in Table 1. However. the fittinQS"§'hall meet the specified periormance requirements when fitted to
reference fittings as specified in 5.1.

\
\ 1) Double-start, right-hand thread of 2,5 mm pitch.

Figure 1 - Male 6 % (Luer) conical lock fitting with permanently connected internally threaded collar

'1
I

I
r
I

: i :
I

: I :
I I
-'---_L_~__

NOTE For other dimensions, see Figure 1.

Figure 2 - Male 6 % (Luer) conical lock fitting with rotatable internally threaded collar
 ISO 594-2: 1998(E)

I
---l
A

I I
I I
I
I
I
I I
I
I
I I
I
I
I
I I
I
I
I I
I
---1 I I
I
I
: I
I
A -
--I
a) Variant A

r
i

r-i
.
v~ I

..E!}~
---.;.-----~---
I
-~

b) Variant 8 c) Variant C

NOTE 1 If a female 6 % (Luer) conical lock fitting has lugs in a plane inclined to the axis of fitting, the lugs should form a part
of the thread form shown in Figure 4. In this case, 'V' does not apply. .

,'lOTE 2 Variants Band C are intended to be used for the design of rigid fittings only.

~lOTE 3 To ensure compatibility with existing rigid fittings, a maximum K =' 0,(3 mm is preferred.

Figure 3 - Female 6 % (Luer) conical lock fittings with lugs in a plane at right angles to axis of fitting
 o 594-2:1998(E) ©IS\...,

r
I

..

:,

I
I

1) Pitch.

NOTE For other dimensions, see Figure 3.

Figure 4 - Fernaie 6 % (Luer) lock conical fittil'g with external thread

.';'0 ISO 594-2:1998(E)

Table 1 - Dimensions of 6 % (Luer) rigid conical lock fittlnqs

...••.•. , Dimensions in millimetres

Symbol Designation Dimensions

Figures 1, 2, Figures 3b)

3a) and 4 and 3c)

a Angle of thread or lug bearing surface against separation with the

25°
+"0 ~o 25° +~:
plane perpendicular to the axis of lock fitting
-
{J Minimum angle of internal thread non-bearing surface against
separation with the plane perpendicular to the axis of lock fitting
25° -
---- "

v
I
Minimum angle of external thread or lug non-bearing surface against
0° 0°
separation with the plane perpendicular to the axis of the lock fitting
--
E Minimum length of male lock fitting 7,5 -
F Nominal distance from the face of the fitting to the base of the lug - 0,20
- --
. , "~3~il'-fl.li-n (.:...:i;:.i(Js (n::};n~tAr Iernale lock Iittin g at base of iucs
,
,:.~ -, v::; I
.~; - \"..~~.l: mpil-
-l' •.•• • _ . ...;. "I;. l':>~I;..:)' t""lr·or .•.~ • his
- ,(, •.••• , diameter ('hjll .r-ct h.~ , r. -
,,' _. ,! I..') 1\ •••...•• •.••.• '_ol ;,_.-"1. I.I~ •• ••I C .... '_4.':. 0, 13 .:J. / I

increased for a distance from the hub face of !3,5 mm

~
......
H Root diameter of the thread of male lock littlnq 8,0 ± 0,1 -
'j, Crest diameter of the thread of male lock fittinq 7,0 ± 0,2 -
J( Maximum thread width of male lock fitting at root 1 , -
._-
P Minimum projection of nozzle from collar 2,1 --
..
Q Minimum thread crest width of male lock fittings 0,3 -
S Lug crest width or thread crest width of female lock fitting with lugs or
0,3 min. 0,27 rnax.
external thread
, .-
r Maximum distance from tip of male lock fitting to the bottom of first
3,2 -
complete thread form of the internal thread
,
V ivlaximum chord length at base of lug in a plane at right angles to axis
!
of fitting only, to be measured on a chord of a circle the diameter of 3,5 5,0
which is J min. (7,0 mm) ~
--
W Minimum chord length at extremity of lug in a plane at riq~t angles to
axis of fitting only (W shall not be greater than II)
2,71 -
.-
X Distance from axis of female lock fitting to extremity of. lug - -

I 2X Outside diameter across the lugs or external thread 7,83 -0,1 ° 7,80 -0,1
°
I y Maximum width of base of lug (axial) or thread at base, of female lock
I fitting to be measured at a point corresponding to an outside diameter- 1,2 1,30
equal to G (6.73 rnax.)

Z Width across the lugs at external thread

-
- 6,50 -0,1 °
Pitch Nominal pilch of double-start, right-hand thread of female lock fitting
?,5 -
I . 5 mrn lead
 ©ISO·
o 594-2:1990(E)

~4 Requirements
4.1 Gauging

r Wr1en tested with the appropriate gauge, the co~~part of the lock fittirg shall comply with ISO 594-1.

4.2 Leakage

4.2.1 Llquld leakage

When the fitting is tested in accordance with 5.2, there shall be no leakage sufficient to form a falling drop.

4.2.2 Air leakage

"

When the fitting is tested in accordance with 5.3, there shall be no signs of continued formation of air bubbles. Bubbles
formed during the first 5 s shall be disregarded.

4.3 Separation force

When the fitting is tested ih accordance with 5.4, it shall remain attached to the reference fitting.

Vvhen the fitting is tested in accordance with 5.5, it shall remain attached to the reterence fitting.
-,
4.5 Ease of assembly

Wh.en the fitting under test is mounted by hand on the appropriate reference fitting in accordance with 5.6, the following
criterion, as appropriate; shall be satisfied:
,
a) rigid fittings: no resistance shall be observed until the taper of the fitting under test and the reference fitting fit
together securely;

b) .serni-riqid fittings: a satisfactory fit shall be achieved by applying an axial force not exceeding 20 N while applyinc
a torque not exceeding 0,08 Nrn.

4.6 Resistance to overriding

When the fitting is tested in accordance with 5.7, the reference fitting shall not override the threads or lugs of the fitting
under test.

4.7 Stress cracking

When the fitting is tested in accordance with 5.8, there shall be no evidence of stress cracking of the fitting.

NOTE Materials used for fittings should be resistant to stress cracking in environments likely to be encountered in Lise
(e~g. when in contact with solvents, surface-active agents, etc.).

5 Test methods

5.1 General

Tests shall be carried out usinq the appropriate reference fitting; reference fittings are shown in Fiqures 5 tc 8. The
reference fittings shall be manufactured from hardened corrosion-resistant materials with a surface roughness value,
FI;1, not exceeding. 0,8 um (in accordance with ISO 468) on critical surfaces. The dimensions of the conical part of these
reference fittings shall be in accordance with those specified in Figures 4 and 5 of ISO 594-1:1986.
/©/ISO ISO 594-2:1 D98(E)

5.2 Liquid leakage from fitting assembly under pressure

5.2.1 Connect the fitting to be tested to a reference fitting, the dimensions of which are in accordance with those
shown in Figure 5 or Figure 7, as appropri,-Ory both fittings. Assemble the fittings by applying an axial force not
exceeding 27,5 N while applying a torque not exceeding 0,12 Nm.

!:i.2.2 Introduce water into the assembly and expel the air. Ensure that the outside of the fitting assembly is dry.

5.2.3 With the axis of the lock fitting horizontal, seal the assembly outlet and bring the internal water pressure to an
effective pressure of 300 kPa to 330 kPa and maintain the pressure for 30 s.

If the intended use is on a device employing higher pressure, then this shall be taken into consideration during testing.

5.3 Air leakage into fitting assembly during aspiration

5.3.1 .3eneral

Other validated test methods (e.g. methods involving automatic testing) may be used if good correlation is shown with
tle reterence test given in 5.3.2 or 5.3.3. In cases of dispute, the methods given in this part of ISO 594 shall be the
referee methods,

5.3.2 Male ;;;'i"S

5.3.2.1 Connect the male fitting to a female reference fitting, the dimensions of which are in accordance with those
shown in Figure 5. Dry both fittings. Connect the male fitting to the female reference fitting by applying an axial force
rot exceeding 27,5 N while applying a torque not exceeding 0,12 Nrn.

5.3.2.2 Connect the female reference fitting, via a leakproof joint of minimal volume, to a syringe which has passed
the test in accordance with ISO 7886-1 for leakage past the piston during aspiration.

S.3.2.3 Draw into the syringe, through the assembly, a volume of recently boiled and cooled water exceeding 25 % of
the graduated capacity of the syringe. Avoid wetting the outside of the assembly.

5.3.2.4 Expel the air except for a small residual air bubble and adjust the volume of water in the syrinqe to 25 % of the
graduated capacity.

5.3.2.5 Occlude the device below the fitting assembly. With the nozzle of the syringe pointing downwards, withdraw
the plunger to nominal capacity and hold for 15 s. '

5.3.3 Female fitting

~
Follow the same test procedure as specified in 5.3.2, but using a syrinqe with a male reference fitting, the dimensions
)fwhich are in accordance with those shown in Figure 7, to mate with the female fitting under test.

').4 Separation force of fitting assembly

'i.4.1 Connect the fitting to be tested to a reference fitting, the dimensions of which are in accordance with thosa
shown in Fiqure 6 or Figure 8 as appropriate; follow the same assembly procedure as specified in 5.2.1 for liquid
eakaqe testing.

=)4.2 Apply an axial force progressively up to 35 N in a direction away (rom the test fixture. AP~IY the force at a rate .of
ipproxirnately 10 N/s and maintain it for not less than 1 0 s. Do not apply any force In other directions or any Inertial
»adinq.

----
 ©ISO.
J. 594-2:1998(E)

5.5 Unscrewing torque of fitting assembly

55.1 Follow the same assembly procedure as specified in 5.4.1.

~,

5.!5.2 'Apply an unscrewing torque of (0,02 -g,002) Nrn to the assembly.and maintain for not less than 10 s. Do not

apply any force in other directions or any inertial loading.

5.6 Ease of assembly

Mount by hand the fitting under test on the male or female reference fitting (see Figures 5 and 7) as appropriate. For
rigid fittings, assemble the fittings securely; for semi-rigid fittings, apply an axial force not'exceeding 20 N together with
a torque not exceeding 0,08 N·m.

5.7 Resistance to overriding

Follow the same procedure as specified in 5.2.1 for liquid leakage testing, but using the' appropriate reference fittinn
shown in Figure !3or Figure 8; apply a torque not less than 0,15 N·m to the fitting under test and hold constant for 5 s.

5.8.1 Connect the fitting to be tested to a reference fitting, the dimensions of which are in accordance with those
shown in Fiqures 5 and 7, as appropriate. Dry both fittings. Assemble the fittings by applying an axial force not less
than 27,5 N for 5 s while applying a torque not less than 0,12 N·m.

5.8.2 Allow the fittings to remain assembled for (48 ± 1) il at (20 ± 5) °C.

NOTE The use of (27 ± 5) "C is accepted as an alternative to (20 ± 5) °C for tropical countries.
.<~JSO ISO 594~2:19!~8(E)

Dimensions in millimetres

A-·j'
o
'" 6. 73 -0.01

A
----I
!

T
1
1
I 1
1
1 1
1
I 1
1
1
! 1
1
,
1 1 1

,I
1
1 1
I 1
I 1
1 I I
1
1
I 1
1
1 1 1
1 1
1
I
J I I
I \
I

-~--l

NOTE All outside edges of lug or thread form shall have a radius between ll, 15 mm and 0,2 mm (unless otherwise specified).

filJure 5 - Female reference conical fitting for testing mule 6 % (Luer) lock flatlngs for leakaqo,
ease of assembly, unscrewing torque and stress crackinq (see 5.2,5.3,5.5,5.6 and 5.8)
 .594-2: 1998(E)

Dimensions in rnillirnetres

A-A
.0.01

-I-
~1 I
r;-r-n
I
: ,; :
I
I I
I I
I I
I I
I I
I I
I I
I I
I I
I I
I I
I I
·4' o
) l 25· 0 . .10· -I.

·-~--~

I ·0,005
L
I
<J> -',73---'l§O _
i
I
NOTE All outside edges of lug or thread form shall have a radius between 0,15 rnrn and 0,2 mrn (unless otherwise specified).

Figure 6 - Female reference conical fitting for testing male 6 % (Luer) lock fittings for separation force
and resistance to overriding (see 5.4 and 5.7)
 594-2:199B(E)

"1

.-..\-~-

lCS 11.040.20
Oescriptors: medical equipment, syringes, hypcderrruc needles, fittings, conical clamping connections, lockinq devices, specilications
'jimensions, tests, pressure tests,
,i

INTERNATIONAL STAI\lDARD ISO 594/1-1986 (E)

--~-----. .~--~----,----------------------~-~---------

Conical fittings with a 6 % [Luer) taper for syringes,

needles and certain other medical equipment
Part 1: General requirements

o Introduction NOTE - It is not practicable to define the characteristics of rigid or

serni-rigid materials with precision, but glass and metal may be con-
In this revision of ISO/R 594 first published ill 1967, the oppor- sidered as typical rigid materials. By contrast, many plastic materials
tunity has been taken to incorporate test methods for gauging may be regarded as semi-rigid although the wall thickness is an impor-
and performance.· tant factor influencing the rigidity of a component.

It should be noted that the annex dOElSnot form an integral part

of the standard.
2 References
ISO 594/2 deals with lock fittings.
ISO 594/2, Conical fittings with a 16 % il.uerl taper for syringes,
needles and certain other medical equipment - Part 2: Lock
fittings. 1)
1 Scope and field of application
ISO 7813G, Sterile hypodermic syringes for sinq!« use.
i'
This part of ISO 594 specifies requirements for conical fittings
with a 6 % ILuer) taper for use with hypodermic syringes and
needles and with certain other apparatus for medical use such
as transfusion and infusion sets. 3 Dimensions

It covers conlcal fittings made of rigid and of semi-rigid The dimensions otrnale and female conical fittings shall be as
materials and includes test methods for gauging and perfor- given in the table and as shown in figure '1.
mance. It excludes provision for more flexible or elastomeric
materials. A typical assembly of 6 % (Luer) conical fittings is shown it
figure 2.
Figure 1 illustrates typical male 6 % (Luer) conical fitting ("mule
fitting") and female 6 % (Luer) conical fitting ("female fitting"). The dimensions of the assembly shall be 8H given in the table

1) At present at the stage of draft.

ISO 594/1·-1986 (E)

Dimensions in ruillirnetr es

Main fi % (Luer) conical filling ("male fitting") RO,5max.

or chamfer

-------------,---...tI<..

-- ---.-_ - -- ------- .- ------- - ---,--- -- I:::J

-n!f--------------fli
E ••

Female 6 % (t.uer] conicat fittinq ("female fittinq") R 05 max.

Figure 1-· Typical 6 % (Luer) conical fittings

(see the correspondinq values in the table)

----------

--Female fit1inn
Male fining---

Figure 2 - Typical assembly of 6 % (Luer) conical fittings

(see the correspondinq values in the table)
 ll!J4/1-19B6 (E)

!3.:i.1.2 Connect the reference female fitting by means of a

1-
:.J Tost mothods leakproof joint of minimal volume to a syringe, the latter having
prevlouslv passed the test for leakage past the piston during
5.'1 Gauginn test aspiration, in accordance with ISO 7886.

The procedure shall be carried out as specified in (j.'1.1 to~

5.3.1.3 Draw into the syringe, through the device and the
female reference a volume of recently boiled and cooled
fittin\l,
5.1:1 Carry out the test using stool (Jau[J8s as illustrated in
water exceeding 25 % of the gl·ar.luatecl capacity of the svrinqa.
figllre 3.

!.i.1.2 Carry out the test at a temperature of (20 ± 5) °C. 5.3.1.4 Expel the air except for a small residual air bubble.

5.1.3 Prior to testing, condition products made from 5.3.1.5 Adjust the volume of water in the syringe to 25 % of
hygroscopic materials at (20 ± ~i) °C and (50 .l: 10) % relative the graduated capacity.
humidity for not loss than 24 h. Conditioning is not required for
products made from non-hvqroscopic materials.
{~,.3.'1.6 Occlude tho device below tho conical fittinl] t'5sumbly.

().1A Apply t\io Uauuu to thu ccnlcul littill\.) wlth IJ tutul uxlul
"::e of 5 N, without the use of torque. Remove the axial load. 5.3.1.7 With the nozzle of the svrinqe downwards, withdraw

I the plungerto nominal capacity. Hold for 15 s.

5.2 Test method tor liquid leakage from the

conical fitting assembly under pressure 5.:1.2 Female fittinqs

The procedure shall be carried out as specified in 5.2.1 to 5.2.0. Conduct the test as for 5.3.1 but using a syringe with a steel
male reference fitting in accordance with fiqure 5 to mate with
5.2.1 Connect the conical fitting to be tested to a steel male the female fitting under test.
or female reference fitting, the dimensions of which are in ac-
NOTE -- Other test methods (e.g. involving automatic testinq) mil)' be
cordance with those shown in figure 4 or 5, as appropriate,
used if good correlation is shown with the reference test specified
both components being dry. Assemble the components by ap
above.
plyin,:j an axial force of 27,5 N for 5 s whilst applying a twisting
action '.0 a value of torque not exceedinq 0,1 N·rnto give a
rotation not exceeding 90". 5.4 Test method for separation force of conical
fitting assembly
5.2.2 Introduce water into the assembly.
The procedure shall be carried out as sper.ified in 5.4.1 and
5.4.2.
5.2.3 Expel air.

[;.4.1 Assemble as for liquid loai<nfjo toslinU in 5.2.

5.2.4 Ensure that the outside of the conical'fittinn aS~;()ITI\)ly i~.i

5.4.2 Apply an axial force of 25 N in a direction away from the

test fixture at a rate of approximately 10 N/s for a period of not
5.2.5 Seal the assembly outlet and bring the internal water
less than 10 s.
pressure to nil effective pressure of :300 kPa.

5.7..13 Maintain the pressure for :30 s.

5,5 Me\hod of testing for stress cracklnq

NOTE - Other test methods (an example is given in the annex) may be The procedure shall be carried out as specified in 5.5.1 to 5.5.3.
used if good correlation is shown with the reference test specified above.

5.5.1 Connect the conical fitting to be tested to a steel male

5.3 Test method for air leakaqe into the conical or female reference fitting, the dimensions of which are in ac-
flttinq assembly during aspiration cordance with those shown in figure 4 or 5, as appropriute.
both components being dry'. Assemble the components by ap-
plying an axial force of 27,5 N for 5 s whilst applying a twistinq
5.3.1 Male fittings
action to' a value of torque not exceeding 0,1 N·m to give a
Q
The procedure shall be carried out as specified in 5.3.1.1 to 5.3.1.7. rotation not exceeding 90 •

"

5.3.1.1 Connect the male conical fitting to a female reference 5.5.2 For single-use hypodermic needles, leave the fittings
fittinq the dimensions of which are in accordance with those assembled for 24 h at (20 ± 5) °C.
shown in figure 4, both components being dry. Apply the male
fitting to the female reference fitting with an axial force of 27,5 N
5.5.3 For general equipment other than that described in
for 5 s whilst applying a twistinq action to a value of torque not
5.5.2, leave the fittings assembled for 48 h at (20 ± 5) DC.
exceeding 0,1 Nvrn to qive a rotation not axceodinq 90".

4
 ISO 594/1-1!)Il\.

Table .- Dimensions of 6 % [Luer) conical fittings

------.----r-----.---.------------------------------------------.-------------.---.----------
Dimensions lrnm)
noference Designation
------- -------
rigid semi-rigid
material material
----r------------------------------------------4-------I----
Basic {min. Minimum diameter of the end of the male conical fitting (reference diameter) 3,925 3,925
dimensions d
max. Maximum diameter at the end of the male conical fitting 3,990 4,021

min. Minimum diameter at the opening of the female conical fitting 4,270 4,270
D{
max. , Maximum diameter at the opening of the female conical fitting 4,315 I 4,315

C Minimum length of the mule conical fitting 7,500 7,000

F Minimum depth of the female conical fitting 7,500 7,500

------ ----.------j---- --------._---- - ------------I-----~·---
Other L' Minimum length 0' engagement 4,665 4.050
dimensions
(If" Tolerance for length of engagement of the female conical fitting 0.150 .0,750

N' Tolerance for length of "n9a\jement of tile male conical filling 1,083 1,700.

U" IlHlX. Hndius of curvature 0,!5 0,5

----_._.-----------------_.'-------._ ..
Dimnnsionu L, M nnd N nro dorivorl from tllo ba~;ic dimnnsious.

0;' uquivalont unu v chnmlor without nnv sharp corners.

4 Requirem(mts The axis of the conical fitting under test shall be horizuntal.

4.1 Gauging
4.3 Air leakage
Vvhen tested in accordance with 5.1, the conical fitting shall
satisfy the requirements specified in 4. '1,1 and 4, '1,2.
Continued formation of air bubbles shall not be evident une
the test conditions described in 5.3. Bubbles formed during t
4.1.1 The small end of the mare conical Iittinq shall lie between first 5 s shall be ignored,
tile two limit planes of the gaunt:! and the larger end of the tapered
portion shall extend beyond the datum plane of the gauge.
4.4 Separation force
Rocking shall not be evident between-the g,luge and the fitting
made of rigid 1) material undergoing 'test.
The conical fitting under test shall remain attached to the u
fixture, under the test conditions described in 5.4,
4.1,2 The plane of the maximum diameter at the opening of
the female conical fitting shall lie between the two limit planes
of the gauge. ' 4.f:i Stress cracking
I

Rocking shell not be evident between the gauge and the fitting
\
made of rigid 1) material undergoing test. -fhere shall be no evidence of stress cracking of the conical
1 ting, under the test conditions described in 5.5.
i
4_2 Liquid lenkaqn
I
I
There shall be no lcakaqe sufficient to form a fullin£! drop of
NOTE - Materials used for conical fittinqs should be resistant to str
I cracklnq in environments likely to be encountered In use'(for (J)W 11 ,

water under the test conditions described in 5.2, when in contact with alcohols},
\

1") -The~~~ freedom from rockin\J may iJ£ found useful for .ovallJatinH semi-rink! fitting!!,
1- 5.3.1.2 Connect the reference female fitting by means ofa
o Test methods
leakproof joint of minimal volume to a syringe, the latter havinq
previously passed the test for leakage past the piston during
5.'1

The procedure
Gauqinq test

shall be carried out as specified

",
in [;.1.1 to 5.1.4.
aspiration, in accordance with ISO 7886.

5.3.1.3 Draw into the syringe, through the device and the
5,1." Curry out the tost usinq steel naU(Jes ClS illustrated in female reference fitting, a volume of recently boiled and cooled
fifJure 3, water exceeding 25 % of the gl'aduated capacitv of the svrinqa.

5.1.2 Carry out the test at a temperature of (20 ± 5) DC. 5.3.1.4 Expel the air exceptTor a small residual air bubble.

5.1.3 Prior to testing, condition products made from

:'.3.1.5 Adjust the volume of water in the syringe to 25 % of
hygroscopic rnaterials at (20 :1: 5) DC and (50 ± 10) % relative
the graduated capacity.
humidity for not less than 24 h. Conditioning is not required for
products made from non-hvqroscoplc materials.
!~
..3"1.6 Occlude tll(! device below tile conical filtillq ..ssemblv.
(j.1,1l Apply tho Uaill/U 10 tlw couloul IIllill\.1 wlrh 1.1 l u lul Hxiul
",;e of 5 N, without the use of torque. Remove the axial load. 5.3.1.7 With the nozzle of' the svrinqe downwards, withdraw
I the plunger to nominal capacity. Hold for 15 s.
5.2 Test methodIor liquid leakage from the
conical fitting assembly under pressure 5.:1.2 Female flttinqs

The procedure shall be carried out as specified in 5.2.1 to 5.2,(-;'

Conduct the test as for 5.3.1 but using a syringe with a steel
male reference fitting in accordance with figure 5 to mate with
5.2.1 Connect the conical fitting to be tested to a steel male the Ierna'e titting uncler test.
or female reference fitting, the dimensions of which are in ac-
cordance with those shown in figure 1\ or 5, as appropriate, NOTE -- Other test methods (e.g. involvinq automatic testinq) may be
both components being dry. Assemble the components by ap- used if gooel correlation is shown with the reference test specified
plying an axial force of 27,5 N for 5 s whilst applying a twisting above.
action ',0 a value of torque not exceedinq 0,1 N.mto give a
rotation not exceeding 900.
5.4 Test method for separation force of conical
fitting assembly
5.2.2 Introduce water into the assembly.
The procedure shall be carried out as specified in 5.4.1 and
5.2.3 Expel air.
5.4.2.

5.2.4 Ensure that the outside of the conical fitting aS~;OIT11JIy

is !i.4.1 Assemble as for liquid loakaqu tostinn in ~).2.

5.4.2 Apply an axial force of 25 N in a direction away from the

5.2.5 Seal the assembly outlet and bring the internal water test fixture at a rate of approximately 10 N / s for a period of not
pressure to an effective pressure of 300 kPa. less than 10 s. '

5.2.6 Maintain the pressure for :30 s. 5.5 Method of testing for stress cracking

NOTE - Other test methods (an example is given in the annex) may be
Tho procedure shall be carried out as specified in 5,5.1 to 5.5.3.
used if good correlation is shown with the reference test specified above.

5.3 Test mothod for air leakage into the conical 5.5.1 Connect the conical fitting to be tested to a steal male
or female reference fitting, the dimensions of which are in ac ..
fittlnq assembly during aspiration
cordance with those shown in figure 4 or 5, as appropriate,
both components being dry. Assemble the components by ap-
5.3.1 Male fittings plying an axial force of 27,5 N for 5 s whilst applying a twistinq
action to' a value of torque not exceeding 0,1 N.m to qive a
The procedure shall be carried out as specified in ri.3.1.·1 to 5.3.1.7.
rotation not exceedinq 900•

5.3,1:1 Connect the male conical fittin~J to a female reference

5.5.2 For single-use hypodermic need les, leave the fittings
fitting the dimensions of which are ill accordance with those
assembled for 24 h at (20 ± 5) DC.
shown in figure 4, both components beinq dry. Apply the male
fitting to the female reference fitting with an axial force of 27,5 N
for 5 s whilst applying a twisting action to a value of torque not 5.5.3 For general equipment other than that described in
exceeding 0,1 N.m to Slive a rotation not exceerlinq 90". 5.5.2, leave the fittinqs assembled for 48 h at (20 :I.: 5) "C.

.'
4
 /

ISO 594/1-1911\,

Table - Dimensions of 6 % (Lue r} conical fittings

------
Dimensions [rnrn)
~ I~uference Designation
rigid : , semi-rigid
material material
-----
Basic {min, Minimum diameter of the end of the male conical fitting (reference diameter) 3,925 3.925
dimensions Ii
max. Maximum diameter at the end of the male conical fitting 3,990 4,027

Minimum diameter at the openin g of the female conical fitting 4,270 ). 4,270
{min.
I
o max, Maximum diameter at the openin g of the female conical fitting 4,:315 I 4,315

E Minimum length of the male can ical fitting 7,500 7,500

F Minimum depth of the female co nical fitting 7,500 7,500

---------------------~-- ----- -----
Other L' Minimum length of engagement 4,665 4,050
dimensions
r....r Tolerance for length of engagem ent of the female conical fitting 0,750 0,750

N' Tolerance for lenqth of engagem ent of tire male conical fitting 1,083 1./00

-
N .••. mux.
._-----_. __ .-
nndills of curvature O,!5 0,-.o
Dhuonsionu I., M IInd N oro dorivod trom tlro bnsic dimensions.

0;' equivalent unuv chumlur without nnv sharp cornurs.

tl Requirements The axis of the conical fitting under test shall be horizontal.

4.1 Gauging
4.3 /I..ir leakage
Whfm tested in accordance with 5. '1, the conical fitting shall
satisfy the requirements specified in 4. '1.1 and 4. '1.2.
Continued formation of air bubbles shall not be evident unc
the test conditions described in 5.3. Bubbles formed during t
4.1.1 The small end of the rnaie conical fitting shall lie between first 5 s shall be ignored. .
the two limit planes of the gaune and the larger end of the tapered
portion shall extend beyond the datum plane of the (lauge.
4.4 Separation force
Rocking shall not be evident l:ietween .the gauge and the 'fitting
made of rigid 1) material underqoinq test.
The conical fitting under test shall remain attached to the tt
fixture, under the test conditions described in 5.4.
4.1.2 The plane of the maximum diameter at the opt;11ing of
the female conical fitting shall lie between the two limit planes
\ of the gauge.
I

Rocking shall not be evident between the gauge and the fitting ~
I made of rigid 11 material underyoing test. There shall be no evidence
ting, under the test conditions
of stress cracking
described
of the conical
in 5.5.

\ 4.2 Liquid Ieakaqo:

I NOTE - Materials used for conical fittings should be resistant to str
\I There shall be no leakago sufficient to form a fallinn drop of crocking in environments likely to be sucountored In 1.160 (for 0;(011'
i water under the test conditions described in 5.2. when in contact with alcohols).

ll-The test~ freedom from rockiny may be found useful toravaluatlnq serni-rigid flttin~Js,
 Dimensions in miilimetres

J
Reference tiiameter

1-
.f' rvrvr:
Limit co 0 +v,vv::J
ch '=l P,~fl 0
< <

planes \;:. 3,92~-O.OOi_ ...;;t ~ ,~ ~ - !!I!oo I

,
I
I
r
r'
j"
\
i I
i\ ! <\ '3
-, I ,,,
\ Datum piane

I IA ~ ,
I

,
.i I
~, f ~I
-i i
l.I'")
r--l
I
~:I ~W3!9~OI
.'
~ !

I
J~t·jj
C/> 4.270 \
i'
I
I ~f,
~ ~« t~

.:>
<

I
f "\ "\~ II ). Datum piane

I
~ce::eJ
(]I.' 1:..

Female
,375
cone.
I +G,005
0
~
taper (0.06 : j j
,1

planes I )
'I
i I
I j I
i if:>
i o,OOS
4/315~ a ~
I
~
Reference diameter

Male cone. taper (0.06 : 1)

a) Ga~ge 70r ~~s!ir;g rjg~d o) Gauge Tor testing semi-rigid c) Gauge fer testing, ,
mo:e ::;on!!:2! nttings rnaie conicel iittings f.emafe conical fittinps
of aH materials

,
Fi;;ure 3 - Gauges 10; reszinq 6 % fLue;} conical fittings
ISO 094/1·1900 (E)

Dimensions in millimetres

'_•. 7 5 min.
"-'-.-------:...I----------~,....

-4-------.-'-----·----~
5367

Cone taper (0,06 : 1i

Figurn 4 -- Reference steel female conical fitting

Dimensions in millimntrns

______ ~ 7.J_~1!liD.:_ , . ~-

"---=w=~~~~~ ~I _
, g_ 81
-- -- ----- -- - -'--- -- - -~~ - -- ---- 0 J~
------ - ---- --,---- - ----- .. ~ - ---- - +--~
------ ,------ - - - ----- ---- - - ----;.,;t ---- - - (Y)~

.-e.~ .@ .
,.l'I.

565
------~'-------~-
Cone taper (0,06 : 1)

Figure 5 - Beference steel male conical fitting

 ISO 5H4/1-1986 0; J

Annex

liquid leakage
(This annex, given only as an example, does not form part of the standard.)

Pi. 1 Specification
\

When testing the leakage characteristics in accordanc() with clause A.2, the established leakage rate sh311 not exceed 0,005 Pa.m h;
This value of the leakage raft) shall be considered as a criterion during a test. 3

A.2 Test method for leakage rate

The IJrocedure shall be carried out as foliows:

Connectshown
those tho conical
In fiOlll'ofiltino to as
4 or 5, be appropriato.
testee! to u steel male or female reference fittinfj the dimensions of which are in accord£lnce with

Assemble 0,1theN,compononts
ceeding by applying
m to give a rotatiQn an axial force
not exceedino 900. of 27,5 N for 5 s whilst applying a twisting action to a value of torque not e)(-

Seal the Outlet bore of the fitting uncler test so that it is airtight.

After connection, apply compressed air at a pressure of approximately 3 x 105 Pa to the fitting in the reference fitting through the
bore. Calculate the leakage rate, L, on the basis of the following form~ia:

3 X 105 L~f}
L ----- x V x
fJ /).f

where

L is the leakage rate, in pascals cubic metres per second;

V is the volume, in cubic metres, of the test specimen and the experimental apparatus;
6.p is the pressure drop, in pascals, during the test period;
6.f is the test period, in secorJds;

p is the test pressure, in pascals,

5
Example:
(0,1 bar) isAtestablished
a test pressure
within ofa 2,9 x 10
period Pa s.
of 2~ (2,9 bar) and a total volurnn of 10 " '10 -- (j m3 (10 mil, IJ IJr99flliro drop of 1 x 104 I'll

3 x 10[;
L ----- 'ID'I
2,9 X 105 X 10 x 10':'6 x -- = 0,0041 Pa.m3/s .
25

-----