EN ISO 595-2:1994

Reusable all-glass or metal-and-glass syringes for medical use - Part 2: Design, performance requirements and tests (ISO 595-2:1987)

Specification of the materials, construction and assembly, performance requirements like resistance to dry heat and corrosion, freedom from leakage, etc. and the test methods and procedures of reusable syringes for medical use.

Wiederverwendbare medizinische Glasspritzen oder Spritzen aus Glas und Metall - Teil 2: Konstruktion, Anforderungen an die Funktion und Prüfungen (ISO 595-2:1987)

In diesem Teil von ISO 595 werden die Konstruktion, die Funktion und die entsprechenden Prüfmethoden für wiederverwendbare Spritzen mit einem skalierten Fassungsvermögen von 1ml bis 100ml zur allgemeinen Anwendung in der Medizin festgelegt. Dieser Teil von ISO 595 bezieht sich auf Glasspritzen oder auf Spritzen in Metall-Glaskonstruktion.

Seringues réutilisables en verre ou en verre et métal à usage médical - Partie 2: Conception, performances et essais (ISO 595-2:1987)

La présente partie de l'ISO 595 spécifie la conception, les performances et les méthodes d'essai correspondantes des seringues réutilisables à usage médical général, dont la capacité graduée varie de 1 à 100 ml. La présente partie de l'ISO 595 s'applique aux seringues en verre ou en verre et métal.

Injekcijske brizge iz stekla ali kovine in stekla za večkratno uporabo v medicini - 2. del: Zasnova, zahteve za kakovost in preskusi (ISO 595-2:1987)

General Information

• Status: Withdrawn
• Publication Date: 30-Aug-1994
• Withdrawal Date: 06-May-2013
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• 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: 07-May-2013
• Completion Date: 07-May-2013
• Ref Project: SIST EN ISO 595-2:2000 - Reusable all-glass or metal-and-glass syringes for medical use - Part 2: Design, performance requirements and tests (ISO 595-2:1987)

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2000
,QMHNFLMVNHEUL]JHL]VWHNODDOLNRYLQHLQVWHNOD]DYHþNUDWQRXSRUDERYPHGLFLQL
GHO=DVQRYD]DKWHYH]DNDNRYRVWLQSUHVNXVL,62
Reusable all-glass or metal-and-glass syringes for medical use - Part 2: Design,
performance requirements and tests (ISO 595-2:1987)
Wiederverwendbare medizinische Glasspritzen oder Spritzen aus Glas und Metall - Teil
2: Konstruktion, Anforderungen an die Funktion und Prüfungen (ISO 595-2:1987)
Seringues réutilisables en verre ou en verre et métal a usage médical - Partie 2:
Conception, performances et essais (ISO 595-2:1987)
Ta slovenski standard je istoveten z: EN ISO 595-2:1994
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.

ISO
INTERNATIONAL STANDARD
595-2
First edition
1987-12-15
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
ORGANISATION INTERNATIONALE DE NORMALISATION
MEXClyHAPOaHAfl OPI-AHM3A~MFl I-IO CTAHflAPTM3A~MM
Reusable all-glass or metal-and-glass syringes
for medical use -
Part 2:
Design, Performance requirements and tests
Seringues r&hlisables en verre ou en verre et /netal& usage mddical -
Partie 2: Conception, performances et essais
~ Reference number
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of
national Standards bodies (ISO member bedies). The work of preparing International
Standards is normally carried out through ISO technical committees. Esch 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 patt 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 ISO Council. They are approved in accordance with ISO procedures requiring at
least 75 % approval by the member bodies voting.
International Standard ISO 595-2 was prepared by Technical Committee ISO/TC 84,
Syringes for medical use and needles for injections.
Together with ISO 595-1 : 1986 it cancels and replaces ISO Recommendation
R 595 : 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 Organkation for Standardkation, 1987 l
Printed in Switzerland
ISO 595-2 : 1987 (E)
INTERNATIONAL STANDARD
Reusable all-glass or metal-and-glass syringes
for medical use -
Part 2:
Design, Performance requirements and tests
4 Construction and assembly
0 Introduction
This International Standard on reusable syringes for medical
4.1 General
use comprises two Parts: ISO 595-1 covers the dimensions and
details of the scale and ISO 595-2 (this part of ISO 595) covers
4.1.1 The construction shall be such that the Piston is com-
design, Performance and test methods.
pletely removable from the barrel.
1 Scope and field of application
4.1.2 The nozzle shall be a male conical fitting with a 6 %
(Luer) taper in accordance with ISO 594-1 and/or ISO 534-2.
This patt of ISO 595 specifies the design, performante and the
corresponding test methods for reusable syringes having a
4.1.3 On syringes having a capacity up to 2 ml, the nozzle
graduated capacity from 1 to 100 ml, for general medical use.
shall be situated centrally on the barrel. On syringes having a
capacity above 2 ml, the nozzle shall be situated either centrally
This part of ISO 595 is applicable to syringes of all-glass and
metal-and-glass construction. or eccentrically on the barrel.
If the nozzle is situated eccentrically, the distance between the
axis of the nozzle and the nearest Point of the internal surface
2 References
of the barrel shall be not greater than 4 mm and the nozzle axis
ISO 594-1, Conical fittings witb a 6 YO (Luer) taper for syringes, shall be, diametrically opposite the scale on the barrel.
needles and certain other medical equipment - Part 7: General
requiremen ts.
4.1.4 In all cases, the axis of the nozzle shall be parallel with
the axis of the barrel.
ISO 594-2, Conical fittings with a 6 YO fLuerJ taper for syringes,
needles and certain other medical equipment - Part 2: Lack
fittings. l)
4.1.5 The bore of the nozzle shall be centrally situated in the
nozzle.
3 Materials
4.1.6 A means of braking the Piston shall be provided unless
the barrel and packaging are marked to indicate that no means
3.1 Glass
of braking is provided.
Soda glass shall not be used for the manufacture of syringes.
If a means of braking the Piston is provided, it shall besuch that
when the Syringe is held in a vertical Position with the nozzle
uppermost, the Piston shall remain stationary and shall not slide
3.2 Metal
down under its own weight.
If a metal part is protected by means of an electroplated or
The braking action shall be such as not to interfere unduly with
other type of coating, the base metal shall be capable of pass-
ing the test specified in 6.3 in the absence of the coating. the Operation of the Piston in the Syringe.
1) At present at the Stage of draft.

ISO 595-2 : 1987 (El
5 Performance requirements
4.2 All-glass syringes
4.2.1 When examined with normal or corrected Vision, the in- ’ 5.1 Resistance to thermal shock
side of the barrel and the outside of the Piston shall have a
When tested in accordance with 6.1, there shall be no fracture
smooth finish and shall be free from surface defects, such as
...