EN ISO 8537:2008
(Main)Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007)
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007)
ISO 8537:2007 specifies requirements and test methods for sterile syringes, with or without needles, solely for the injection of insulin. The syringes are single-use only, primarily for use in humans. It covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100).
Sterile syringes specified in ISO 8537:2007 are intended for use soon after filling as they are not suitable for containing insulin over extended periods of time.
Sterile Insulin-Einmalspritzen mit oder ohne Kanüle (ISO 8537:2007)
Diese Internationale Norm legt Anforderungen und Prüfungen für sterile Insulin-Spritzen mit oder ohne Kanüle
fest, die ausschließlich zur Injektion von Insulin dienen. Diese Einmal-Spitzen sind vorrangig für die
Anwendung am Menschen vorgesehen. Sie gilt für Spritzen zur Verwendung mit Insulin der Konzentration von
40 Einheiten/ml (U-40) und 100 Einheiten/ml (U-100).
Die in dieser Internationalen Norm beschriebenen sterilen Spritzen sind zum alsbaldigen Gebrauch nach dem
Füllen bestimmt, da sie nicht zur Aufbewahrung von Insulin über längere Zeit vorgesehen sind.
Seringues à insuline, stériles, non réutilisables, avec ou sans aiguille (ISO 8537:2007)
L'ISO 8537:2007 spécifie des exigences et des méthodes d'essai applicables aux seringues stériles avec ou sans aiguille destinées uniquement à l'injection d'insuline. Les seringues ne sont pas réutilisables et sont utilisées principalement chez l'homme. Elle couvre les seringues utilisées avec 40 unités d'insuline/ml (U-40) et 100 unités d'insuline/ml (U-100).
Les seringues stériles dans l'ISO 8537:2007 sont prévues pour être utilisées immédiatement après leur remplissage, puisqu'elles ne sont pas adaptées pour contenir de l'insuline pendant de longues périodes.
Sterilne injekcijske brizge za insulin za enkratno uporabo, z iglo ali brez nje (ISO 8537:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2008
1DGRPHãþD
SIST EN ISO 8537:2000
SIST EN ISO 8537:2000/A1:2001
Sterilne injekcijske brizge za insulin za enkratno uporabo, z iglo ali brez nje (ISO
8537:2007)
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007)
Sterile Insulin-Einmalspritzen mit oder ohne Kanüle (ISO 8537:2007)
Seringues à insuline, stériles, non réutilisables, avec ou sans aiguille (ISO 8537:2007)
Ta slovenski standard je istoveten z: EN ISO 8537:2008
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.
EUROPEAN STANDARD
EN ISO 8537
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2008
ICS 11.040.25 Supersedes EN ISO 8537:1994
English Version
Sterile single-use syringes, with or without needle, for insulin
(ISO 8537:2007)
Seringues à insuline, stériles, non réutilisables, avec ou Sterile Insulin-Einmalspritzen mit oder ohne Kanüle (ISO
sans aiguille (ISO 8537:2007) 8537:2007)
This European Standard was approved by CEN on 15 June 2008.
CEN members are bound to comply with the CEN/CENELEC 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 bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre 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 CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8537:2008: E
worldwide for CEN national Members.
Contents Page
Foreword.3
Foreword
The text of ISO 8537:2007 has been prepared by Technical Committee ISO/TC 84 “Medical devices for
injections” of the International Organization for Standardization (ISO) and has been taken over as EN ISO
8537:2008 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held
by DIN.
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 January 2009, and conflicting national standards shall be withdrawn at
the latest by January 2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8537:1994.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 8537:2007 has been approved by CEN as a EN ISO 8537:2008 without any modification.
INTERNATIONAL ISO
STANDARD 8537
Second edition
2007-10-01
Sterile single-use syringes, with or
without needle, for insulin
Seringues à insuline, stériles, non réutilisables, avec ou sans aiguille
Reference number
ISO 8537:2007(E)
©
ISO 2007
ISO 8537:2007(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2007
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2007 – All rights reserved
ISO 8537:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Types of syringe . 3
5 Freedom from extraneous matter . 3
6 Limits for extraneous matter . 3
7 Lubrication of syringes and needles . 4
8 Range of sizes. 4
9 Graduated scale . 4
10 Barrel. 5
11 Piston/plunger assembly . 5
12 Nozzle. 6
13 Needle tubing and needles . 6
14 Performance of assembled syringe. 6
15 Packaging . 7
16 Marking . 8
Annex A (normative) Fluid for determination of acidity/alkalinity and extractable metals . 11
Annex B (normative) Test method for air leakage past syringe piston during aspiration . 12
Annex C (normative) Test method for force required to operate plunger. 14
Annex D (normative) Properties of needles and needle tubing . 15
Annex E (normative) Test method for determination of dead space. 17
Annex F (normative) Test method for liquid leakage at syringe piston and syringe nozzle/hub or
needle/barrel unions during compression. 18
Annex G (normative) Test method for air leakage past nozzle/hub or needle/barrel unions during
aspiration. 20
Annex H (informative) Preparation of extract for test for pyrogenicity and toxicity . 21
Annex I (informative) Symbol for “do not re-use” . 22
Bibliography . 23
ISO 8537:2007(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation 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 right 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 Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 8537 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products
and intravascular catheters.
This second edition cancels and replaces the first edition (ISO 8537:1991) and its Amendment 1
(ISO 8537:1991/Amd.1:2000), which have been technically revised.
iv © ISO 2007 – All rights reserved
ISO 8537:2007(E)
Introduction
This International Standard deals with products primarily intended for use with humans and provides
performance requirements, but permits some variations of design and of the methods of packaging and
sterilization by individual manufacturers.
Materials to be used for the construction and lubrication of sterile syringes and needles for single use are not
specified as their selection will depend to some extent upon the design, process of manufacture and
sterilization method employed by individual manufacturers.
Syringes and needles should be manufactured and sterilized in accordance with recognized national or
international codes of good manufacturing practice for medical devices, and should be free from defects
affecting appearance, safety and serviceability for their intended use.
Certain grades of polypropylene, polystyrene and styrene/acryIonitrile copolymer have been extensively used
for the barrels of sterile syringes for single use. A high quality natural rubber composition is frequently used for
the piston, although other materials such as silicone rubber are also used, the surface of the piston being
lubricated with polydimethylsiloxane. For 2 ml syringes, high density polyethylene is frequently used for the
seal of the two-component design of syringe in combination with a polypropylene barrel containing a fatty acid
amide slip additive.
When selecting materials, make the following considerations:
⎯ Clarity of barrel: Materials used in the construction of the wall of the syringe barrel should be of sufficient
clarity to enable dosages to be read without difficulty and for air bubbles to be seen.
⎯ Compatibility with insulin preparations: The materials of syringes and needles (including lubricant) and
packaging should not, in their final form after sterilization and under conditions of normal use,
detrimentally affect the efficacy, safety and acceptability of insulin preparations: neither should the
construction materials themselves be affected physically or chemically by insulin preparations.
⎯ Biocompatibility: The materials should not cause the syringes and needles to yield, under conditions of
normal use, significant amounts of toxic substances and should permit them to satisfy the appropriate
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.