EN 20594-1:1993

Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)

Specification of the requirements for conical (Luer) fittings for use with hyperdemic syringes and needles and with certain other apparatus for medical use such as transfusion and infusion sets. It covers fittings made of rigid and semi-rigid materials and includes test methods for gauging and performance. It excludes provision for more flexible or elastomeric materials. The annex on liquid leakage is given as an example.

Kegelverbindungen mit einem 6% (Luer) Kegel für Spritzen, Kanülen und bestimmte andere medizinische Geräte - Teil 1: Allgemeine Anforderungen (ISO 594-1:1986)

Dieser Teil von ISO 594 behandelt im einzelnen Anforderungen für Kegel- verbindungen mit einem 6 % (Luer) Kegel zur Verwendung bei Injektionsspritzen und -kanülen sowie bei bestimmten anderen medizinischen Transfusions- und Infusionsgeräten. Behandelt werden Kegelverbindungen aus starren und halbstarren Werkstoffen, im weitern werden Verfahren zur Prüfung der Masse und der Gebrauchstauglich- keit aufgeführt. Ausgenommen sind Bestimmungen für weiche und elastomerische Werkstoffe.

Assemblages coniques à 6% (Luer) des seringues et aiguilles et de certains autres appareils à usage médical - Partie 1: Spécifications générales (ISO 594-1:1986)

La présente partie de l'ISO 594 fixe les spécifications pour les assemblages coniques à 6 % (Luer) des seringues et aiguilles et de certains autres appareils à usage médical, tels que le matériel de transfusion et de perfusion. Ces spécifications s'appliquent aux assemblages coniques constitués de matériaux rigides ou semi-rigides et incorporent des méthodes d'essai pour le calibrage et les performances. Elles ne concernent pas les raccords constitués de matériaux souples ou en élastomères. La figure 1 donne un exemple de raccord conique à 6 % (Luer) mâle («raccord mâle») et de raccord conique à 6 % (Luer) femelle («raccord femelle»).
NOTE -- En pratique, il n'est pas possible de définir avec précision les caractéristiques de ces matériaux rigides ou semi-rigides; cependant le verre et le métal peuvent être considérés comme des matériaux rigides typiques. En revanche, de nombreux matériaux plastiques peuvent être qualifiés de semi-rigides, tout en considérant que l'épaisseu

Stožčaste spojke s 6-odstotnim (Luerjevim) nastavkom za injekcijske brizge, igle in nekatero drugo medicinsko opremo - 1. del: Splošne zahteve (ISO 594-1:1986)

General Information

• Status: Withdrawn
• Publication Date: 18-Aug-1993
• Withdrawal Date: 13-Apr-2025
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 31-May-2017
• Completion Date: 14-Apr-2025
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 20594-1:2000 - Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)

Relations

• Replaced By: EN ISO 80369-7:2017 - Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01)
• Effective Date: 30-Nov-2016
• Amended By: EN 20594-1:1993/A1:1997 - Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)
• Effective Date: 08-Jun-2022
• Corrected By: EN 20594-1:1993/AC:1996 - Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2000
6WRåþDVWHVSRMNHVRGVWRWQLP/XHUMHYLPQDVWDYNRP]DLQMHNFLMVNHEUL]JHLJOH
LQQHNDWHURGUXJRPHGLFLQVNRRSUHPRGHO6SORãQH]DKWHYH,62
Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical
equipment - Part 1: General requirements (ISO 594-1:1986)
Kegelverbindungen mit einem 6% (Luer) Kegel für Spritzen, Kanülen und bestimmte
andere medizinische Geräte - Teil 1: Allgemeine Anforderungen (ISO 594-1:1986)
Assemblages coniques a 6% (Luer) des seringues et aiguilles et de certains autres
appareils a usage médical - Partie 1: Spécifications générales (ISO 594-1:1986)
Ta slovenski standard je istoveten z: EN 20594-1:1993
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

International Standard
INTERNATIONAL ORGANIZATION FOR STANDARDIZATIONWblEJK~YHAPO~HAR OPTAHM3A~MR IlO CTAH~APTkl3AL&Wl.ORGANlSATlON INTERNATIONALE DE NORMALISATION
Conical fittings with a 6 % (Luer) taper for syringes,
needles and certain other medical equipment -
Part 1: General requirements
Assemblages coniques ;i 6 % (her) des seringues et aiguifles et de certains autres appareifs ;i usage medical -
Partie 7 : Spkifications g&&ales
First edition - 1986-06-15
Ref. No. IS0 594/l-1986 (E)
U DC 615.473.36
syringes, hypodermic needles, fittings, conical clamping connections, specifications, dimensions, tests,
Descriptors : medical equipment,
pressure tests.
Price based on 7 pages
Foreword
IS0 (the International Organization for Standardization) is a worldwide federation of
national standards bodies (IS0 member bodies). The work of preparing International
Standards is normally carried out through IS0 technical committees. Each member
body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, govern-
mental and non-governmental, in liaison with ISO, also take part in the work.
Draft International Standards adopted by the technical committees are circulated to
the member bodies for approval before their acceptance as International Standards by
the IS0 Council. They are approved in accordance with IS0 procedures requiring at
least 75 % approval by the member bodies voting.
International Standard IS0 59411 was prepared by Technical Committee ISO/TC 84,
Syringes for medical use and needles for injections.
Together with IS0 594/Z, it cancels and replaces IS0 Recommandation R 594-1967, of
which it constitutes a technical revision.
Users should note that all International Standards undergo revision from time to time
and that any reference made herein to any other International Standard implies its
latest edition, unless otherwise stated.
0 International Organization for Standardization, 1986 0
Printed in Switzerland
IS0 594/l-1986 (E)
INTERNATIONAL STANDARD
Conical fittings with a 6 % (Luer) taper for syringes,
needles and certain other medical equipment -
Part 1: General requirements
It is not practicable to define the characteristics of rigid or
0 Introduction NOTE -
semi-rigid materials with precision, but glass and metal may be con-
sidered as typical rigid materials. By contrast, many plastic materials
In this revision of ISO/R 594 first published in 1967, the oppor-
may be regarded as semi-rigid although the wall thickness is an impor-
tunity has been taken to incorporate test methods for gauging
tant factor influencing the rigidity of a component.
and performance.
It should be noted that the annex does not form an integral part
of the standard.
2 References
IS0 594/Z deals with lock fittings.
IS0 59412, Conical fittings with a 6 % (Luer) taper for syringes,
needles and certa/i, other medical equipment - Part 2: Lock
fittings. 1)
1 Scope and field of application
IS 0 7886, Sterile hypodermic syringes for single use.
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
3 Dimensions
as transfusion and infusion sets.
The dimensions of male and female conical fittings shall be as
It covers conical fittings made of rigid and of semi-rigid
given in the table and as shown in figure 1.
materials and includes test methods for gauging and perfor-
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 ( “female fitting ”). The dimensions of the assembly shall be as given in the table.
1) At present at the stage of draft.
ISO!W/l-1986(E)
Dimensions in millimetres
Male 6 % (Luer) conical fitting ( “male fitting ”)
R 0,5 max.
chamfer
----- ----- ~~---~~~~~ ~~---~~~~~ _ _
---w-------m--- ---w-------m---
E E
Female 6 % (Luer) conical fitting ( “female fitting ”)
R0.5 max.
or chamfer
/
?
Figure 1
- Typical 6 % (Luer) conical fittings
(see the corresponding values in the table)
I
--B-B-v- ------.--a
-Female fitting
Male fitting 1
Figure 2 - Typical assembly of 6 % (Luer) conical fittings
(see the corresponding values in the table)

Iso 594/l-1986 (El
Table - Dimensions of 6 % (Luer) conical fittings
Dimensions (mm)
Designation
Reference
rigid semi-rigid
material material
3,925
3,925
min. Minimum diameter of the end of the male conical fitting (reference diameter)
Basic
d
dimensions
3,990 4,027
max. Maximum diameter at the end of the male conical fitting
4,270 4,270
Minimum diameter at the opening of the female conical fitting
min.
D
4,315 4,315
Maximum diameter at the opening of the female conical fitting
max.
{
7,500
7,500
E Minimum length of the male conical fitting
7,500
7,500
F Minimum depth of the female conical fitting
4,665 4,050
Minimum length of engagement
Other L”
dimensions
0,750 0,750
Ad* Tolerance for length of engagement of the female conical fitting
1,083 1,700
N” Tolerance for length of engagement of the male conical fitting
0,5 0,5
R** max. Radius of curvature
* Dimensions L, IM 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 511, the conical fitting shall
satisfy the requirements specified in 4.1.1 and 4.12.
Continued formation of air bubbles shall not be evident under
the test conditions described in 5.3. Bubbles formed during the
first 5 s shall be ignored.
4.1.1 The small end 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.
4.4 Separation force
Rocking shall not be evident between the gauge and the fitting
made of rigid ’) material undergoing test.
The conical fitting under test shall remain attached to the test
fixture, under the test conditions described in 5.4.
The plane of the maximum diameter at the opening of
4.1.2
the female conical fitting shall lie between the two limit plane
...