- ~

S T D - B S I B S EN 20594-1-ENGL 1 9 9 4 W L b 2 4 b b 9 ü b 9 1 7 5 7 b24 W

5s EN
i05941 : 1994
SO 594-1 :1986
ncorpomting
imendmmt No. 1 to
!S 3930 :Pa#rt1 : 1987
renumbers BS as
lS EN 20594-1 i 1994)
Conical fittings with a 6 % ind Amendme7lt No. 1
! BS EN 20594-1 :1994
--``,`-`-`,,`,,`,`,,`---

(Luer) taper for syringes,

needles and certain other
medical equipment
Part 1. General requirements

*
m
*

The European Standard EN 205941 : 1993, with the incorporation of its

amendment Al : 1997 has the status of a British Sîandard

ICs 11.040.20
I
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 BS EN 20594-1 : 1994 Issue 2, March 1998

Contents
Page Page
National foreword Inside front cover Annex
Committees responsible Back cover Liquid leakage 7
I Foreword ii
ZA Clauses of this European Standard addressing
Specification essential requirements or other provisions of
EU Directives 8
O. Introduction 1
1. Scope and field of application 1 Table
2. References 1 Dimensions of 6 %
' (Luer) conical fittings 3
3. Dimensions 1
4. Requirements 3 Figures
5. Test methods 2
1. Typical 6 % (Luer) conical fittings
2. Typical assembly of 6 % (Luer) conical fittings 2
3. Gauges for testing 6 % (Luer) conical fittings 5
4. Reference steel female conical fitting 6
5. Reference steel male conical fitting 6
National foreword
This Part of BS 3930 has been prepared under the direction of the Health Care Standards Committee and is the
Englishlanguage version of EN 20594-1 : 1993 'Conical fittings with a 6 % (Luer) taper for syringes, needles and
other medical equipment -Part 1: General requirements', including amendment A l . It is identical with
IS0 594-1 : 1986, published by Technical Committee 84 'Syringes for medical use and needles for injection' of the
InternationalOrganization for Standardization (ISO).
BS 3930 'Specification for conical fittings with 6 per cent (Luer) taper for hypodermic and other surgical equipment' was
first published in 1965 and specified requirements for Luer slip fittings made of rigid materials, e.g. metal, glass. This
standard is the first Part of a two-part revision of BS 3930 : 1965 and specifies requirements for Luer slip fittings made of
rigid and semi-rigid materials. It supersedes BS 3930 : 1965, which is withdrawn. The second Part of this revision will
specify requirements for Luer lock fittings (which were not covered in the 1965 edition), and will implement I S 0 594/2.
This Part of BS 3930 also supersedes the requirements for Luer slip fittings made of semi-rigid materials given in BS 5081 :
1976 'Sterile hypodermic syringes and needles for single use'. BS 5081 i s itself being revised in two Parts so as to take
account of I S 0 7864 'Sterile hypodermic needles for single use' and IS0 7886 'Sterile hypodermic syringes for single use'
and to delete the dimensional requirements for Luer fittiiigs.
In 1993 the European Committee for Standardization (CEN) accepted IS0 594-1 : 1986 as European Standard
EN 20594-1 : 1993. As a consequence of implementing the European Standard this British Standard is renumbered
as BS EN 20594-1 and any reference to BS 3930 : Part 1 should be read as a reference to BS EN 20594-1.

Terminology and conventions. The text of the international standard has been approved as suitable for publication as a
British Standard without deviation. Some terminology and certain conventions are not identical with those used in British
Standards; attention is drawn especially to the following.
The comma has been used as a decimal marker. In British Standards it is current practice to use a full point on the baseline
as the decimal marker.
Wherever the words 'this part of I S 0 594' appear, they should be read as 'this Part of BS 3930'.
Cross-references
The British Standards which implement internationalor European publications referred to in this document may be
found in the BSI Standards Catalogue under the section entitled 'International Standards Correspondence Index', or
by using the 'Find' facility of the BSI Standards Electronic Catalogue.
I
Additional information. With reference to the table of dimensions, dimension F i s not intended to proscribe fittings
which are only tapered to the depth of socket equivalent to the maximum length of engagement and which are not
tapered for the remainder of the minimum depth of the fitting. The IS0 t e x t will be amended to take account of this
when the standard i s revised.
Compliance with a British Standard does not of itself confer immunity from legal obligations.

--``,`-`-`,,`,,`,`,,`---

*in preparation.
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 ~ ~

Issue 1, March 1998 BS EN 20594-1 : 1994

Summary of pages
The following table identifies the current issue of each page. Issue 1 indicates that a page has been introduced
for the first time by amendment. Subsequent issue numbers indicate an updated page. Vertical sidelining on
replacement pages indicates the most recent changes (amendment, addition, deletion).
Page Issue Page Issue
Front cover 2 1 to 6 Original
inside front cover 2 7 Original
a 1 8 2
b blank Inside back cover original
EN title page 1 Back cover 2
11 1

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O BSI 1998 a
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S T D - B S I BS E N 20594-1-ENGL
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Not for Resale l b 2 4 b b 9 ûb91959 YT7
 S T D - B S I B S E N 20594-L-ENGL 1 9 9 4 m Lb24bbS Ob9L9b0 119

EN 205941
--``,`-`-`,,`,,`,`,,`---

August 1993

+ Al
November 1997

UM: 615.473.36

Descriptors: Medical equipment, syringes, surgical needles, perfusion equipment, blood transfusion equipment, joining, fittings,
specifications, dimensions, tests

English version
Conical fiUings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment -
Part 1: General requll-ements
(includuig amendment A l : 1997)
(IS0 594-1 : 1986)
Assemblages coniques à 6 % (Luer) des seringues Kegelverbindungen mit einem 6 % (Luer) Kegel
et aiguilles et de certains autres appareiis à usage fur Spritzen, Kanülen und bestimmte andere
médical - medizinische Gerate -
Partie 1: Spécifications généraies Teil 1: Allgemeine Anforderungen
(inclut i'amendement A l : 1997) (enthalt Änderung A l : 1997)
(Is0 59Q-1: 1986) (IS0 5W1:1986)

This European Standard was approved by CEN on 19934812. CEN members are
bound to comply with the CEN/CENELEC internai Regulations which stipulate the
conditions for giving this European Standard the status of a national standard
without any alteration.
Up-to-date lists and bibiiographical references concerning such national standards
may be obtained on application to the Central Secretariat or to any GEN member.
This European Standard exists in three officiai 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 notifíed to the Central
Secretariat has the same status as the officiai 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.

CEN
European Conunittee for Standardization
Comité Européen de Normaìisation
Europäisches Komitee fur Normung

Central Secretariat: rue de Stassart 36, B-1050Brussels

~~~~~ ~

O 1993 Copyright reserved to CEN nieinbers

Ref. No. EN 205941 : 1993 + A l : 1997 E

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EN 20594-1:1993
Foreword
in 1989, Is0594-1 : 1986 Cmicalflttings with a 6 %
(Luer) taperfor syrìnges, 728ed(es and certain OW
medical equ.ilmzent -Pa?? 1: ceneral requiremats
was submithi to the CEN primary Quesüonnajre
procedure.
Foilowing the positive result of the CEN/CS Proposai,
IS0 594-1 : 1986 was submitted to the Formai Vote.
The result of the Fonnal Vote was positive.
This European Standard shaii be given the status of a
national standard, either by publication of an identical
text or by endorsement, at the latest by February 1994,
and confiicting nationai standards shall be withdrawn
at the latect by February 1994.
According to the CEN/CENELEC Intemaì Regulations,
the following countries are bound to implement this
European Stanàard Austria, Belgium, Denmark,
Finland,France, Germany, Greece, Iceland, ireland,
Italy, Luxembourg, Netherlands, Norway, Portugal,
Spain, Sweden, Switzerland, United Kingdom.
ii
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Issue 1, March 1998
Foreword to amendment A l
This amendment EN 20594-1 : 1993A1: 1997 to
EN 20594-1 : 1993 has been prepared by Technical
Committee CENA'C 206, Non-acüve medical devices,
the secretariai of which is held by BSI.
This amendment to the European Standarà
EN 20594-1 : 1993 shall be given the status of a national
standard, either by publication of an identical text or
by endorsement, at the latest by May 1998, and
corúlicting national stanàards shall be withdrawn at
the latest by May 1998.
This amendment consists of annex ZA to
EN 20694-1 : 1993.
For relationship with EU DWve(s), see informative
annex ZA, which is an integral part of this standard.
According to CEN/CENELEC Intemal Regulations, the
--``,`-`-`,,`,,`,`,,`---
following countries are bound to implement this
European Standard: Austria, Belgium, Czech Republic,
Denmark, Fïnland, France, Gennany,Greece, Iceland,
ireland, Italy, Luxembourg, Netherlands, Norway,
Portugal, Spain, Sweden, Switzerland and the United
Kingdom.
Not for Resale
 ~~ ~

S T D - B S I BS EN 20574-1-ENGL 1994 Lb24bbf Obf1îb2 T71 =

BS 3930 : Part 1 : 1987

British Standard

Conical fittings with a 6 % (Luer)taper for

syringes, needles and other medical equipment
Part 1. Specification for general requirements
--``,`-`-`,,`,,`,`,,`---

O Introduction NOTE - It is not practicable to Mine the charactefistics of rigid or

In this revision of ISO/R 594 first published in 1967, the oppor-
tunity has been taken to incorporate test methods for gauging
and performance.
semi-rig¡¡ materials with precioion, but glass and metal may be con-
sidered as typical rigid materials. By contrast, many plastic materials
may bei 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
I S 0 W / 2 deals with lock fittings.
IS0 59412, Comcal fittings with a 6 % (Lueri taper for syringes,
needles and certain other medical equipment -
Pari 2: Lock
fittings. 1)
1 Scope and field of application

--
-
=
-
e
-
This part of IS0 594 specifies requirements for conical fittings
with a 6 % (Luer) taper for use with hypodermic syringes and
needles and with certain other apparatus for medical use such
IS0 7886, Sterile hypodermic syringes for single use.

E
II as transfusion and infusion sets. 3 Dimensions
* It covers conical fittings made of rigid and of semi-rigid The dimensions of male and female conical fittings shall be as
III
* 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 in
figure 2.
Figure 1 illustrates typical male 6 % (Luer) conical fitting ("male
fitting") and female 6 % (Luer) conical fitting I"femalefitting"). The dimensions of the assembly shall be as given in the table.

1) At present at the stage of draft.

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~
 Dimensions in millimetres

Male 6 % (Luerl conical fitting ("male fitting")

R 0.5 max .
chamfer

Female 6 % iLuer) conical fitting ("femalefitting"b

-
Figure 1 Typical ô % (Luer) conical fittings
[seethe correspondingvalues in the table)

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

(see the corresponding values in the tabiel

--``,`-`-`,,`,,`,`,,`---

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 ~
~

STDVBSI B S E N 2059LI-L-ENGL 1994 l b 2 Y b b 9 Ub7L7b4 ôb4

BS 3930 : Part 1 : 1987

Table - Dimensions of 6 % (Luert conical fittings

I Reference Ouignition
I üimensionstmm)
rigid semi-rigid
material
1

Basic min. Minimum diameter of the end of the male conical fitting (referencediameter) 3,925
dimensions
I(Mx. Maximum diameter at the end d the male conical fitting 4,027
min. Minimum diameter at the opening of the female conical fitting 4.270 4.270
'{ max, Maximum diameter at the opening qf the female conical fitting 4,315 4,315

E Minimum length of the male conical fitting

F Minimum depth of the female conicalfitting 7.500
Other L' Minimumlength of engagement 4.665 4.050
dimensions
M' Tolerance for length of engagement of the female conical fitting 0.750 0,750
'
N Tolerance for length of engagement of the male conical fitting 1.083
R" mai Radius of curvature 0.5 0.5
Dimensions L , M and N are derived from the basic dimensions.
** Or equivalent entry chamfer without any sharp corners.

--``,`-`-`,,`,,`,`,,`---
4 Requirements The axis of the conical fitting under test shall be horizontal.

4.1 Gauging
4.3 Air leakage
When 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 under
the test conditions described in 5.3. Bubbles formed during the
4.1.1 The small end of the male conical fitting shall lie beriinreen first 5 s shall be ignored.
the nnro limit pianes oftbe gauge and the iargerendofthe tapered
portion shall exterd beyond the datum piane ofthe gauge.
* 4.4 Separation force
m Rocking shall not be evident between the gauge and the fitting
*
made of rigid11 material undergoing test.
The conical fim'ng under test shall remain attached to the test
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 fming shall lie between the two Iimit planes
of the gauge. 4.5 Stress cracking
Rocking shall not be evident between the gauge and the fitting
made of rigid 1 ) material undergoing test. There shall be rio evidence of stress cracking of the conical fit-
ting, under the test conditions described in 5.5.
4.2 Liquid leakage
NOTE - Materials used for conicalfittings should be resistantto stress
Th shall be no leakage sufficient to form a falling drop of cracking in environments likely to be encounteredin use (for example
W L C under
~ the test conditions described in 5.2. when in contact with aicohok).

II The test for freedom from rocking may be found useful for evaluating semi-rigid fittings.
3
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 BS 3930 : Part 1 : 1987
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.
5.1.2 Carry out the test at a temperature of (20 f 5) OC.
5.1.3 to testing* condition products made from
hygroscopic mterials at (20 f 5) O C and (50f 10) % relative
humidq 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.
5.2 Test method for liquid leakage from the
conical fitting assembly under pressure
The procedure shall be carried out as specified in 5.2.1 to 5.2.6.
5.2.1 Connect the conical Mring to be tested to a sîeel 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 îï.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 Expei air.
5.2.4 Ensure that the outside of the conical fitting assembly is
dry.
5.2.5 Seal the assembly outlet and bring the internal water
pressure to an effective pressure of 300 kPa.
5.2.6 Maintain the pressure for 30 s.
'OTE - Other test methods (an isgiven in the annex) may be
used if good conelation is shown with the referencetest specifiad above.
5.3 Test method for air leakage into the conical
fitting assembly during aspiration
5.3.1 Male fittings
The procedure Shan be carried out as specified in 5.3.1.1 to 5.3.1.7.
5'3.1'1 the male conical
fitting to a 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 femde reference fitting with an axial force of 27,5 N
for 5 s whilst applying a twisting action to a value of torque not
exoeeding 0.1 N-rn to give a rotation not exceeding 900.
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5.3.1.2 Connect the reference female fitting by means of a
leakproof joint of minimal volume t o a syringe, the latter having
previously passed the test for leakage past the piston during
aspiration, in accordance with I S 0 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.
5.3.1.4 Expel the air except for a small residual air bubble.
5.3.1.5 Adjust t h of water in the syringe to 25 % of
the graduatedcapacity.
5.3.1.6 Occlude the device below the conical fitting assembly.
5.3.1.7 With the nonle of the syringe downwards, withdraw
the plunger to nominal capacity. Hold for 15 s.
5.3.2 Female fittings
Conduct the test as for 5.3.1 but using a syr¡nge 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.
5.4.1 Assemble as for liquid leakage testing in 5.2.
54.2 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
less than 10 s.
5.5 Method of testing for stress cracking
The procedure shall be carried out as specified in 5.5.1 to 5.5.3.
5.5.1 Connect the conical f i n g 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 2ï.5 N for 5 s whilst applying a twisting
action to a value of torque not exceeding 0.1 N.m to give a
rowtion not exceeding
5.5.2 For singleuse hypodermic needles, leave the fittings
for 24 at ,20 i 5, oc.
5.5.3 For general equipment other than that described in
5.5.2, leave the fittings assembled for 48 h at (20 f 5) OC.
Not for Resale
 BS 3930 : Part 1 : 1987

.-C
y>

.-
O
y>

E
0

*
VI
*

I
m
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 S T D - B S I BS EN 2057V-L-ENGL 177q m lb2Libb7 Ob7L7b7 573 m
BS 3930 : Part 1 : 1987

D i d o n s in millimetres

-.-.--

Cone taper (O,@ : 1)

Figure 4 - Reference steel female conical fitting

Dimensions in millimetres

1 1
I 71
_-

l I

cone taper 10.06 : 11

Figure 5 - Reference steel male conical fitting

--``,`-`-`,,`,,`,`,,`---

Copyright European Committee for Standardization

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 -~
~

STD.BSIRS E N 20599-1-ENGL 1994 Lb2LibbS O b 9 L 7 6 8 4 0 T =

BS 3930 : Part 1 : 1987

Annex

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

A.l Specification
When testing the leakage characteristics in accordance with clause A.2, the established leakage rate shall not exceed 0.005 Pa.mj/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 27,5N 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 d 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:

3 x 105 AP
L = - x v x -
P AI

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;
--``,`-`-`,,`,,`,`,,`---

A p is the pressure drop, in pascals, during the test period;

AI is the test period, in seconds:
p is the test pressure, in pascals.

Example: At a test pressure of 2.9 x lo5 Pa (2.9 bar) and a total volume of 10 x 10-6 m3 (10 mll, a pressure drop of 1 x 101 Pa
(O,1 bar) is established within a period of 25 s.
3 x 105 104
L - x 10 x 10-6 x - = 0,OW 1 Pa.mYs
2,g x 105 25

7
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 EN 20594-1 : 1993 Issue 2,March 1998

Annex ZA (infmative)
Clauses of this European Standard addressing essential requirements or other provisions
of EU Directives
This European Standard has been prepared under a mandate given to CEWCENELEC by the European
Commission and the European Free Trade Association and supports essential requirements of EU Directive
934aEEC.
WARNING. Other requirements and other EU Directives - may be applicable to the product(s) falling within the
scope of this standard.
The following clauses of this standard, as given in table ZA.l are likely to support requirements of Directive
93/42/EEC.
Compliance with these clauses of this standard provides one means of conforming with the specific essential
requirements of the Directive concerned and associated ERA regulations.

Clause/subclause of this Corresponding Essential Comments

European Standard Requirement of Directive
W4YEEC
I
3 2, 3, 9.1
4 2. 3. 9.1
~ 4.2 7.5
1I I
4.3
I
7.6
I

I I
12,3, 9.1
I
I

--``,`-`-`,,`,,`,`,,`---
17.5
I I

17.6

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 iZb24bb9
~~

-STD-BSI BS EN 2Ofi4-1-ENGL 1994 ûb91770 ObA

Publications referred to
See national foreword.

--``,`-`-`,,`,,`,`,,`---

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 S T D * B S I BS EN 2057Li-L-EMGL
This British Standard, having been prepared under the direction of
the Health Ccre Standards Committee. was published under the
authority of the Board of BSI and comes into effect on
30 January 1987.
O British Standards Institution, 1998
ISBN O 580 15585 4
BSI is the independent national body responsible for preparing
British Standards. It presents the UK review on standards in.
Europe and at the internationallevel. It is incorporatedby Royal
Charter.
Contract requirements
A British Standard does not purport to includeall the necessary
provisions of a Contract. Users of British Standards are responsible
for their correct application.
Revisions
British Standards are updated by amendment or revision. Users of
British Standards should make sure that they possess the latest
amendments or editions.
li is the constant aim of BSI to improve the quality of our products
and services. We would be grateful if anyone finding an inaccuracy
or ambiguitywhile using this British Standard would inform the
Secretary of the responsibletechnical committee, the identity of
which can be found on the inside front cover. Tel: O1 81 996 9000;
Fax: 0181 996 7400.
BSI offers members an individualupdating service called PLUS
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editions of standards.
Committees responsible for this British Standard
T h e preparation of this British Standard was entrusîed by the
Health Care Standards Committee (HCCI-) to Technical Committee
HCC/2, upon which the following bodies were represented:
Awciation of Clinical Pathologists
British Dental Trade Association
British Diabetic Association
British Surgical Trades Association Incorporated
Amd. No. Date
8072 February 1994
9881 March 1998
British Standards Institution .389Chiswick High Road London W4 4AL Telephone O181 996 9000.Fax O181 996 7400
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L77Li L b 2 4 b b 9 Ob71771 TTLi D
Issue 2, March 1998 BS EN 20594-1 1994
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Disposable Hypodermic and Allied Eqyipment Manufacturers
Association
Glass Manufacturers' Federation
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Pharmaceutical Society of Great Britain
Coopted members
Text affected
Implements EN 20594-1 as a British Standard
New annex ZA
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 ~ ~

STD-BSI BS EN 20594-I-,ENGL I 9 9 4 L b 2 4 b b 7 üb7L772 9 3 0

AMD 9881

Amendment No. 1
published and effective from 15 March 1998
to BS EN 20594-1 : 1994

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other
medical equipment
Part 1. General requirements

Instructions for replacement of pages

The following pages con- new or revised text. Please remove any superseded pages and insert the new or
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EN title page and ii
8
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 BRITISH STANDARD BS EN
20594-1 : 1994
IS0 594-1 : 1986
Incorporating
Amendment No. 1 to
BS393O:Partl: 1987
(rmumbersBS as
BS EN 20594-1 :1994)
Conical fittings with a 6 % and Arnen.dm,ent No. 1
to BS EN 20594-1 : 1994
(Luer) taper for syringes,
needles and certain other
medical equipment
Part 1. General requirements

The European Standasd EN 205941 : 1993, with the incorporation of its

amendment A l : 1997 has the status of a British Standard

ICs 11.040.20

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 ~ ~~ ~

S T D - B S I B S EN 2057q-L-ENGL 1774 LbZLibb7 Ob71774 703 m

BS EN 20594-1 1994 Issue 2, March 1998

Contents
Page Page
National foreword Inside front cover Annex
Committees responsible Back cover Liquid leakage 7
1 Foreword ii
ZA Clauses of this European Standard addressing
Specif ication essential requirements or other provisions of
O. Introduction
EU Directives 8
1. Scope and field of application Table
2. References Dimensions of 6 % (Luer) conical fittings 3
3. Dimensions
4. Requirements Figures
5. Test methods
1. Typical 6 % (Luer) conical fittings 2
2. Typical assembly of 6 % (Luer) conical fittings 2
3. Gauges for testing 6 % (Luer) conical fittings 5
4. Reference steel female conical fitting 6
5. Reference steel male conical fitting 6
National foreword
This Part of BS 3930 has been prepared under the direction of the Health Care Standards Committee and is the
English language version of EN 20594-1 : 1993 'Conical fittings with a 6 % (Luer) taper for syringes, needles and
other medical equipment - Part 1: General requirements', including amendment AI. It is identical with
IS0 594-1 : 1986, published by Technical Committee 84 'Syringes for medical use and needles for injection' of the
International Organization for Standardization (ISO).
BS 3930 'Specification for conical fittings with 6 per cent (Luerl taper for hypodermic and other surgical equipment' was
first published in 1965 and specified requirements for Luer slip fittings made of rigid materials, e.g. metal, glass. This
standard is the first Part of a two-part revision of BS 3930 : 1965 and specifies requirements for Luer slip fittings made of
rigid and semi-rigid materials. It supersedes BS 3930 : 1965, which is withdrawn. The second Part of this revision will
specify requirements for Luer lock fittings (which were not covered in the 1965 edition), and will implement I S 0 594/2.
This Part of BS 3930 also supersedes the requirements for Luer slip fittings made of semi-rigid materials given in BS 5081 :
1976 'Sterile hypodermic syringes and needles for single use'. BS 5081 is itself being revised in two Parts so as to take
account of I S 0 7864 'Sterile hypodermic needles for single use' and I S 0 7886 'Sterile hypodermic syringes for single use'
and t o delete the dimensional requirements for Luer fittiiigs.
In 1993 the European Committee for Standardization (CEN) accepted IS0 594-1 : 1986 as European Standard
EN 20594-1 : 1993. As a consequence of implementing the European Standard this British Standard is renumbered
as BS EN 20594-1 and any reference to BS 3930 : Part 1 should be read as a reference to BS EN 20594-1.

Terminology and conventions. The text of the international standard has been approved as suitable for publication as a
British Standard without deviation. Some terminology and certain conventions are not identical with those used in British
Standards; attention is drawn especially to the following.
The comma has been used as a decimal marker. In British Standards it is current practice t o use a full point on the baseline
as the decimal marker.
Wherever the words 'this part of I S 0 594' appear, they should be read as 'this Part of BS 3930'.
Cross-references
The British Standards which implement international or European publications referred to in this document may L?
found in the BSI Standards Catalogue under the section entitled 'International Standards Correspondence Index', or
by using the 'Find' facility of the BSI Standards Electronic Catalogue.
I
Additional information. With reference to the table of dimensions, dimension F is not intended to proscribe fittings
which are only tapered t o the depth of socket equivalent to the maximum length of engagement and which are not
tapered for the remainder of the minimum depth of the fitting. The IS0 t e x t will be amended to take account of this
when the standard i s revised.
Compliance with a British Standard does not of itself confer immunity from legal obligations.

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@ BSI 1998
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 S T D - B S I BS EN j 0 5 7 4 - 1 - E N G L 1 7 % IL L 2 4 b b 7 Ob71775 bllT I-
Issue 1, March 1998 BS EN 20594-1 : 1994
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Summary of pages
The following table identifies the current issue of each page. issue 1 indicates that a page has been introduced
for the first time by amendment. Subsequent issue numbers indicate an updated page. Vertical sidelining on
replacement pages indicates the most recent changes (amendment, aàdition, deletion).
Page I issue II Page Issue
Front cover 2 1 to 6 original
Inside front cover 2 7 original
a 1 8 2
b blank Inside back cover original
EN title page
11 I: Il Back cover
2

*
vi
*

O BSI 1998
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~~
 EUROPEAN S”Dm EN 205941
NORME EUROPÉENNE August 1993

EuRopALscHE NORM
+ Al
November 1997

UDC 615.473.36

Descriptors Medical equipment, syringes, surgical needles, perfusion equipment, blood transfusion equipment, joining, fittings,
specifications, dimensions, tests

English version
conical fittin@ with a 6 % (Luer) taper for syringes, needles and
certain other medical equipment -
Part 1: General requirements
(including amenàment Al : 1997)
(is0 594-1 : 1986)
Assemblages coniques à 6 % (Luer) des seringues Kegelverbindungen mit einem 6 % (Luer) Kegel
et aiguilles et de certains autres appareiis à usage für Spritzen, Kanülen und bestirnmk andere
médical - medizinische Geräte -
Partie 1: Spéciñcationsgénéraies Teil 1: Allgemeine Anforderungen
(inclut l’amendement Al : 1997) (enthalt Änderung Al : 1997)
(Is0 594-1 : 1986) (Is0 594-1 : 1986)

This European Standard was approved by CEN on 1993-ûû-12.CEN members are

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bound to comply with the CENICENELEC Internal Regulations which stipulate the
conditions for giving this European Standard the status of a national standard
without any alteration.
Up-to-date lists and bibiiographical 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, F’rench,
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.

CEN
European Conmittee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung

Central Secretariat: rue de Stassart 36, B-1050 Brussels

O 1993 Copyright reserved to CEN niembers

Ref. No. EN 205941 : 1993 + A l : 1997 E

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~
 EN 20594-1 : 1993
Foreword
in 1989,IS0 5941: 1986 Conicalfittings with a 6 %
(Lw) taperfor syringa, needles and certain other
medical equipment - Part 1: General requi-
was submitted to the CEN Primary Questionnaire
procedure.
Following the positive result of the CEN/CS Proposal,
IS0 594-1 : 1986 was submitted to the Formal Vote.
The result of the Formai Vote was positive.
This European Standard shall be given the status of a
national standard, either by publication of an identical
text or by endorsement, at the latest by February 1994,
and conflicting national standards shaii be withdrawn
at the latest by February 1994.
According to the CENICENELEC Internai Regulations,
the following countries are bound to implement this
European Standard Austria, Belgium,Denmark,
Finland, France, Germany, Greece, Iceland, Ireland,
Italy, Luxembourg, Netherlands, Norway, Portugai,
Spain, Sweden, Switzerland, United Kingdom.
Copyright European Committee for Standardization
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Issue 1, March 1998
Foreword to amendment A l
This amendment EN 20594-1 : "Al: 1997 to
EN 205941 : 1993 has been prepared by Technical
Committee CEN/rC 205, Non-active medical devices,
the secretariat of which is held by BSI.
This amendment to the European Standard
EN 2CI594-1: 1993 SMbe given the status of a national
standard, either by publication of an identical text or
by endorsement, at the latest by May 1998, and
contlicting nationai standards shall be withdrawn at
the latest by May 1998.
This amendment conssts of m e x ZA to
EN 20594-1 : 1993.
For relationship with EU Dwective(s), see infornxitive
miex ZA, which is an integral part of this standard.
According to CENKENELEC Internai Regulations, the
following countries are bound to implement this
European StandanJ Austria, Belgium, Czech Republic,
Denmark, Finland, France, Germany, Greece, Iceland,
Ireland, Itaiy, Luxembourg, Netherlands, Norway,
Portugal, Spain, Sweden, Switzerland and the United
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Kuigdom.
Not for Resale
 BS 3930 : Part 1 : 1987

Annex

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

A. 1 Specification
When testing the leakage characteristicsin accordance with clause A.2, the established leakage rate shall not e x d 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 Z',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 Wo.

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:

3 x 105 AP
L = - x v x -
P At

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;

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Ap is the pressure drop, in pascals, during the test period:
A? 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 (IO ml), a pressure drop of 1 x 10s Pa
(0.1 bar) is established within a period of 25 s.

3 x 105 104
L = x 10 x 10-6 x - = 0,004 1 Pa-ms/s
2.9 x 105 25

7
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 S T D - B S I BS EN 20574-1-ENGL L77q -6 1b2LibbS üb71979 2 9 5 6
EN 20594-1 : 1993 issue 2,March 1998

Annex ZA (informative)
Clauses of this European Standard addressing essential requirements or other provisions
of EU Directives
This European Standard has been prepared under a mandate given to CEWCENELEC by the European
Commission and the European Free Trade Association and supports essential requirements of EU Directive
93/42/EEC.
WARNING. Other requirements and other EU Directives 3 be applicable to the product(s) falling within the
scope of this standard.
The following clauses of this standard, as given in table ZA.l are likely to support requirements of Directive
93/42/EEC.
Compliance with these clauses of this standard provides one means of conforming with the specific essential
requirements of the Directive concerned and associated EFTA regulations.

Clause/subclause of this Corresponding Essential Comments

European Standard Requirement of Directive
93/42/EEC
3 2, 3, 9.1
4 2, 3, 9.1
4.2 7.5
4.3 7.6
5 2, 3, 9.1
5.2 7.5
5.3 7.6
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 Publications referred to
See national foreword.

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 STDWBSI BS EN 2057q-L-ENGL
Issue 2,March 1998
T h i s British Standard, having been prepared under the direction of
the Health Ccre Standards Committee. was published under the
authority of the Board of BSI and comes into effect on
30 January 1987.
8 British Standards Institution, 1998
ISBN O 580 15585 4
BSI is the independent national body responsiblefor preparing
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Amd. No. Date Text affected
8072 February 1994 Implements EN 20594-1 as a British Standard
9881 March 1998 New annex ZA
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