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`©NopartofthisstandardmaybereproducedwithoutthepriorpermissionofDINDeutscheslnstitutf0!Normunge,V.,Berlin.
`
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`DEUTSCHE NORM
`
`January 1995
`
`
`
`D N|
`
`ICS 11.040.20
`
`
`
`Conical fittings with a 6% (Luer) taper for syringes, needles
`
`and certain other medical equipment
`General requirements
`
`
`(ISO 594-121986)
`
`
`EN 20 594-1
`
` En-
`
`lish version of DIN EN 20594-1
`
`This standard incorporates the English version of ISO 594‘1 .
`Supersedes DIN 13090-1,
`
`
`August 1984 edition.
`Descriptors: Medical equipment, syringe, conical fitting.
`
` Kegelverbindungen mit einem 6% (Luer-)Kegel fUr Spritzen, Kaniilen und be-
`
`stimmte andere medizinische Gerfite; allgemeine Anforderungen
`
`(ISO 954-1 : 1986)
`
`
`
`
`European Standard EN 20594-1 :1993 has the status of a DIN Standard.
`
`A comma has been used as the decimal marker.
`
`National foreword
`
`
`This standard has been published in accordance with a decision taken by CEN/BT to adopt, without alteration, Interna—
`
`
`tional Standard ISO 594-1 as a European Standard.
`The responsible German body involved in its preparation was the NormenausschuB Feinmechanik und Optik (Optics and
`
`Precision Mechanics Standards Committee).
`
` Amendments
`
`
`
`
`In comparison with DIN 13090-1, August 1984 edition, the requirements for leakage as specified in subclause 7.2.1 of
`DIN 13 090-1 have not been adopted, the corresponding methods of test for leakage rate as specified in subclause 8.2.1
`of DIN 13090-1 having been described in an informative annex.
`
`
`Previous editions
`
`
`DIN 13090:1940-09, 1941-07, 1974-06; DIN 13090-1z1957-01, 1984-08.
`
`
`
`
`
`EN comprises 9 pages.
`
`Beuth Verlag GmbH. Berlin. has the exclusive right of sale for German Standards (DIN—Norman).
`07.95
`
`DIN EN 20 594-1 Eng]. Price group 9
`Sales No. 1109
`
`1
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`B. Braun 2019
`
`1
`
`B. Braun 2019
`
`

`

`2
`
`

`

`EUROPEAN STANDARD
`NDRME EUROPEENNE
`August1993
`EUROPAISCHE NORM
`
`
`EN 20594-1
`
`UDC 615.473.36
`
`Descriptors: Medical equipment, syringe, conical fitting.
`
`English version
`
`Conical fittings with a 6 % (Luer) taper for syringes,
`needles and certain other medical equipment
`Part 1: General requirements
`(ISO 594-1 : 1986)
`
`Assemblages coniques a 6% (Luer) des
`seringues et aiguilles et de certains autres
`appareils a usage médical. Partie 1: Spé-
`cifications générales (ISO 594-1 :1986)
`
`Kegelverbindungen mit einem 6% (Luer-)
`Kegel fiir Spritzen, Kanijlen und bestimm-
`te andere medizinische Gerate. Teil1:
`Allgemeine Anforderungen
`(ISO 594-1 :1986)
`
`This European Standard was approved by CEN on 1993-08—12 and is identical to the ISO
`Standard as referred to.
`
`CEN members are bound to comply with the CEN/CENELEC lnternal Regulations which
`stipulate the conditions for giving this European Standard the status of a national standard
`without any alteration.
`Up-to-date lists and bibliographical references concerning such national standards may be
`obtained on application to the Central Secretariat or to any CEN member.
`This European Standard exists in three official versions (English, French, German). A version in
`any other language made by translation under the responsibility of a CEN member into its own
`language and notified to the Central Secretariat has the same status as the official versions.
`CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France,
`Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain,
`Sweden, Switzerland and United Kingdom.
`
`GEN
`
`European Committee for Standardization
`Comité Européen de Normalisation
`Europaisches Komitee fur Normung
`
`Central Secretariat: rue de Stassart 36, 8-1050 Brussels
`
`
`
`© 1993. Copyright reserved to all CEN members.
`
`Ref. No. EN 20594-1 :1993 E
`
`3
`
`

`

`Page 2
`EN 20594-1 :1993
`
`Foreword
`
`In 1989,
`ISO 594-1 :1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment; general
`requirements
`was submitted to the CEN PQ procedure. Following the positive result of the PQ, CEN/BT agreed to submit ISO 594-1 :1986,
`without modifications, for Formal Vote. The result was positive.
`This European Standard shall be given the status of a national standard, either by publication of an identical text or by
`endorsement, and conflicting national standards withdrawn, by February 1994 at the latest.
`In accordance with the CEN/CENELEC Internal Regulations, the following countries are bound to implement this European
`Standard:
`
`Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway,
`Portugal, Spain, Sweden, Switzerland and United Kingdom.
`
`Endorsement notice
`
`The text of the International Standard ISO 594-1 :1986 was approved by CEN as a European Standard without any modifi-
`cation.
`
`4
`
`

`

`Page 3
`EN 20594-1 : 1993
`
`0
`
`Introduction
`
`In this revision of lSO/R 594 first published in 1967, the oppor-
`tunity has been taken to incorporate test methods for gauging
`and performance.
`
`NOTE — It is not practicable to define the characteristics of rigid or
`semi-rigid materials with precision, but glass and metal may be con-
`sidered as typical rigid materials. By contrast. many plastic materials
`may be regarded as semi-rigid although the wall thickness is an impor-
`tant factor influencing the rigidity of a component.
`
`It should be noted that the annex does not form an integral part
`of the standard.
`
`2 References
`
`ISO 594/2 deals with lock fittings.
`
`ISO 594/2, Conical fittings with a 6 % (L uer) taper for syringes,
`needles and certain other medical equipment — Part 2: Lock
`fittings. 11
`
`1 Scope and field of application
`
`ISO 7886, Sterile hypodermic syringes for single use.
`
`This part of ISO 594 specifies requirements for conical fittings
`with a 6 % (Luerl taper for use with hypodermic syringes and
`needles and with certain other apparatus for medical use such
`as transfusion and infusion sets.
`
`3 Dimensions
`
`rigid and of semi-rigid
`fittings made of
`It covers conical
`materials and includes test methods for gauging and perfor-
`mance. It excludes provision for more flexible or elastomeric
`materials.
`
`Figure 1 illustrates typical male 6 % (Luerl conical fitting ("male
`fitting") and female 6 °/o (Luerl conical fitting ("female fitting").
`
`The dimensions of male and female conical fittings shall be as
`given in the table and as shown in figure 1.
`
`A typical assembly of 6 % (Luerl conical fittings is shown in
`figure 2.
`
`The dimensions of the assembly shall be as given in the table.
`
`1) At present at the stage of draft.
`
`5
`
`

`

`Page 4
`EN 20594-1 : 1993
`
`Dimensions in millimetres
`
`
`
`
`Female6 % (Luer) conical fitting ("female fitting")
`
`R 0 5 max.
`or chamler
`
`¢6,73max.
`
`Figure 1 -— Typical 6 % (Luer) conical fittings
`(see the corresponding values in the table)
`
`
`
`Male fitting
`
`Female fitting
`
`Figure 2 — Typical assembly of 6 % lLuer) conical fittings
`(see the corresponding values in the table)
`
`6
`
`

`

`Table — Dimensions of 6 % (Luerl conical fittings
`
`Page 5
`EN 20594-1 : 1993
`
`Reference
`
`Designation
`
`rigid
`material
`
`semi-rigid
`material
`
`Basic
`dimensions
`
`Minimum diameter of the end of the male conical fitting (reference diameter)
`Maximum diameter at the end of the male conical fitting
`
`
`
`Minimum diameter at the opening of the female conical fitting
`
`Maximum diameter at the opening of the female conical fitting
`
`Minimum length of the male conical fitting
`Minimum depth of the female conical fitting
`Minimum length of engagement
`
`Tolerance for length of engagement of the female conical fitting
`
`Tolerance for length of engagement of the male conical fitting
`Radius of curvature
`
`Other
`dimensions
`
`" Dimensions L, M and N are derived from the basic dimensions.
`
`“ Or equivalent entry chamfer without any sharp corners.
`
`4 Requirements
`
`4.1 Gauging
`
`When tested in accordance with 5.1, the conical fitting shall
`satisfy the requirements specified in 4.1.1 and 4.1.2.
`
`4.1.1 The small and of the male conical fitting shall lie between
`the two limit planes of the gauge and the larger end of the tapered
`portion shall extend beyond the datum plane of the gauge.
`
`Flocking shall not be evident between the gauge and the fitting
`made of rigid 1) material undergoing test.
`
`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.
`
`Flocking shall not be evident between the gauge and the fitting
`made of rigid” material undergoing test.
`
`4.2 Liquid leakage
`
`There shall be no leakage sufficient to form a falling drop of
`water under the test conditions described in 5.2.
`
`The axis of the conical fitting under test shall be horizontal.
`
`4.3 Air leakage
`
`Continued formation of air bubbles shall not be evident under
`the test conditions described in 5.3. Bubbles formed during the
`first 5 3 shall be ignored.
`
`4.4 Separation force
`
`The conical fitting under test shall remain attached to the test
`fixture, under the test conditions described in 5.4.
`
`4.5 Stress cracking
`
`There shall be no evidence of stress cracking of the conical fit-
`ting, under the test conditions described in 5.5.
`
`NOTE -— Materials used for conical fittings should be resistant to stress
`cracking in environments likely to be encountered in use (for example
`when in contact with alcoholsl.
`
`1) The test for freedom from rocking may be found useful for evaluating semi-rigid fittings.
`
`7
`
`

`

`Page 6
`EN 20594-1 21993
`
`5 Test methods
`
`5.1 Gauging test
`
`The procedure shall be carried out as specified in 5.1.1 to 5.1.4.
`
`5.1.1 Carry out the test using steel gauges as illustrated in
`figure 3.
`
`5.3.1.2 Connect the reference female fitting by means of a
`leakproof joint of minimal volume to a syringe, the latter having
`previously passed the test for leakage past the piston during
`aspiration, in accordance with ISO 7886.
`
`5.3.1.3 Draw into the syringe, through the device and the
`female reference fitting, a volume of recently boiled and cooled
`water exceeding 25 % of the graduated capacity of the syringe.
`
`5.1.2 Carry out the test at a temperature of (20 :l: 5) °C.
`
`5.3.1.4 Expel the air except for a small residual air bubble.
`
`condition products made from
`to testing,
`5.1.3 Prior
`hygroscopic materials at (20 :l: 5) °C and (50 i 10) % relative
`humidity for not less than 24 h. Conditioning is not required for
`products made from non—hygroscopic materials.
`
`5.1.4 Apply the gauge to the conical fitting with a total axial
`force of 5 N, without the use of torque. Remove the axial load.
`
`5.3.1.5 Adjust the volume of water in the syringe to 25 % of
`the graduated capacity.
`
`5.3.1 .6 Occlude the device below the conical fitting assembly.
`
`5.3.1.7 With the nozzle of the syringe downwards, withdraw
`the plunger to nominal capacity. Hold for 15 5.
`
`5.2 Test method for liquid leakage from the
`conical fitting assembly under pressure
`
`5.3.2 Female fittings
`
`The procedure shall be carried out as specified in 5.2.1 to 5.2.6.
`
`5.2.1 Connect the conical fitting to be tested to a steel male
`or female reference fitting, the dimensions of which are in ac-
`cordance with those shown in figure 4 or 5, as appropriate,
`both components being dry. Assemble the components by ap—
`plying an axial force of 27,5 N for 5 s whilst applying a twisting
`action to a value of torque not exceeding 0,1 N-m to give a
`rotation not exceeding 90°.
`
`5.2.2 Introduce water into the assembly.
`
`5.2.3 Expel air.
`
`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
`the female fitting under test.
`
`NOTE — Other test methods (e.g. involving automatic testing) may be
`used if good correlation is shown with the reference test specified
`above.
`
`5.4 Test method for separation force of conical
`fitting assembly
`
`The procedure shall be carried out as specified in 5.4.1 and
`5.4.2.
`
`5.2.4 Ensure that the outside of the conical fitting assembly is
`dry.
`
`5.4.1 Assemble as for liquid leakage testing in 5.2.
`
`5.2.5 Seal the assembly outlet and bring the internal water
`pressure to an effective pressure of 300 kPa.
`
`5.4.2 Apply an axial force of 25 N in a direction away from the
`test fixture at a rate of approximately 10 Ms for a period of not
`less than 10 s.
`
`5.2.6 Maintain the pressure for 30 5.
`
`5.5 Method of testing for stress cracking
`
`NOTE — Other test methods (an example is given in the annex) may be
`used if good correlation is shown with the reference test specified above.
`
`The procedure shall be carried out as specified in 5.5.1 to 5.5.3.
`
`5.3 Test method for air leakage into the conical
`fitting assembly during aspiration
`
`5.3.1 . Male fittings
`
`The procedure shall be carried out as specified in 5.3.1.1 to 5.3.1.7.
`
`5.3.1.1 Connect the male conical fitting to a female reference
`fitting the dimensions of which are in accordance with those
`shown in figure 4, both components being dry. Apply the male
`fitting to the female reference fining with an axial force of 27,5 N
`for 5 s whilst applying a twisting action to a value of torque not
`exceeding 0,1 N.m to give a rotation not exceeding 90°.
`
`5.5.1 Connect the conical fitting to be tested to a steel male
`or female reference fitting. the dimensions of which are in ac-
`cordance with those shown in figure 4 or 5, as appropriate,
`both components being dry. Assemble the components by ap-
`plying an axial force of 27,5 N for 5 s whilst applying a twisting
`action to a value of torque not exceeding 0,1 N-m to give a
`rotation not exceeding 90°.
`
`5.5.2 For single-use hypodermic needles,
`assembled for 24 h at (20 t 5) °C.
`
`leave the fittings
`
`5.5.3 For general equipment other than that described in
`5.5.2, leave the fittings assembled for 48 h at (20 i 5) °C.
`
`8
`
`

`

`Page 7
`EN 20594-1 : 1993
`
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`

`

`Page 8
`EN 20594-1 :1993
`
`Dimensions in millimetres
`
`7 5 min.
`
`
` ¢l”292.3005
`
`Cone taper (0,06 : 1)
`
`Figute 4 — Reference steel female conical fitting
`
`Dimensions in millimetres
`
`7 5 min.
`
`
` $3.9
`6-3.005
`
`Cone tape! (0,06 1 1)
`
`Figure 5 — Reference steel male conical fitting
`
`10
`
`10
`
`

`

`Page 9
`EN 20594-1 : 1993
`
`Annex
`
`Liquid leakage
`
`(This annex, given only as an example, does not form part of the standard.)
`
`A.1 Specification
`
`When testing the leakage characteristics in accordance with clause A.2, the established leakage rate shall not exceed 0,005 Pa.m3/s.
`This value of the leakage rate shall be considered as a criterion during a test.
`
`A.2 Test method for leakage rate
`
`The procedure shall be carried out as follows:
`
`Connect the conical fitting to be tested to a steel male or female reference fitting the dimensions of which are in accordance with
`those shown in figure 4 or 5, as appropriate.
`
`Assemble the components by applying an axial force of 27,5 N for 5 s whilst applying a twisting action to a value of torque not ex-
`ceeding 0,1 N.m to give a rotation not exceeding 90°.
`
`Seal the outlet bore of the fitting under 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 formula:
`
`Ap
`3X105
`L=——-—-xVx——
`p
`A!
`
`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;
`
`Ap
`
`A!
`
`is the pressure drop, in pascals, during the test period;
`
`is the test period, in seconds;
`
`p is the test pressure, in pascals.
`
`Example: At a test pressure of 2,9 x 105 Pa (2,9 bar) and a total volume of 10 x 10-6 m3 (10 ml), a pressure drop of 1 x 104 Pa
`(0,1 bar) is established within a period of 25 s.
`
`104
`3 x 105
`L = —— x10 x10-6 x —— = 0,0041Pa-m3/s
`2,9 x 105
`25
`
`11
`
`11
`
`