SIST EN ISO 8537:2016

SLOVENSKI STANDARD
SIST EN ISO 8537:2016
01-junij-2016
Sterilne injekcijske brizge za insulin za enkratno uporabo, z iglo ali brez nje (ISO
8537:2016)
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
Sterile Insulin-Einmalspritzen mit oder ohne Kanüle (ISO 8537:2016)
Seringues à insuline, stériles, non réutilisables, avec ou sans aiguille (ISO 8537:2016)
Ta slovenski standard je istoveten z: EN ISO 8537:2016
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 8537:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8537:2016

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SIST EN ISO 8537:2016


EN ISO 8537
EUROPEAN STANDARD

NORME EUROPÉENNE

April 2016
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8537:2008
English Version

Sterile single-use syringes, with or without needle, for
insulin (ISO 8537:2016)
Seringues à insuline, stériles, non réutilisables, avec ou Sterile Insulin-Einmalspritzen mit oder ohne Kanüle
sans aiguille (ISO 8537:2016) (ISO 8537:2016)
This European Standard was approved by CEN on 27 February 2016.

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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8537:2016 E
worldwide for CEN national Members.

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SIST EN ISO 8537:2016
EN ISO 8537:2016 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC amended by Directive 2007/47/EEC . 5
2

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SIST EN ISO 8537:2016
EN ISO 8537:2016 (E)
European foreword
This document (EN ISO 8537:2016) has been prepared by Technical Committee ISO/TC 84 "Devices for
administration of medicinal products and catheters" in collaboration with 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 October 2016, and conflicting national standards shall
be withdrawn at the latest by October 2016.
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 8537:2008.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
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, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
The following referenced documents are indispensable for the application of this document.
For undated references, the latest edition of the referenced document (including any amendments)
applies. For dated references, only the edition cited applies. However, for any use of this standard
‘within the meaning of Annex ZA’, the user should always check that any referenced document has not
been superseded and that its relevant contents can still be considered the generally acknowledged
state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
3

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SIST EN ISO 8537:2016
EN ISO 8537:2016 (E)
Table — Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO or IEC
standard
ISO 594-1 EN ISO 594-1:1986 ISO 594-1:1986
ISO 7864 EN ISO 7864:1995* ISO 7864:1993*
ISO 9626 EN ISO 9626:1995* ISO 9626:1991*
ISO 14971 EN ISO 14971:2012 ISO 14971
ISO 62366-1 EN ISO 62366-1:2015 IEC 62366-1:2015
ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2003
ISO 80369-7 EN ISO 80369-7:2016** ISO 80369-7:2016**
* New versions expected end of 2015.
** Expected 2016.
Endorsement notice
The text of ISO 8537:2016 has been approved by CEN as EN ISO 8537:2016 without any modification.
4

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SIST EN ISO 8537:2016
EN ISO 8537:2016 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC amended by Directive
2007/47/EEC
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to the
Essential Requirements of Directive 93/42/EEC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a
presumption of conformity with the corresponding Essential Requirements of that Directive and
associated EFTA Regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Essential
Clause(s)/subclause(s) of this Requirements (ERs)
Qualifying remarks/notes
European Standard of Directive
93/42/EEC
5.1 m 7.1
6.1.2 c, 6.1.3 c, 6.2 b 7.2
5.2, 5.4 7.3
5.11.2, 5.11.3 7.5
6.1 7.6
6.1.2, 6.1.3, 7.2.2, 7.3, 7.4 8.3
5.1 n 8.4
5.1, 5.4, 5.6, 5.7, 7.3 g, 7.4 h, 7.5 h, 7.6 f 9.2
5.1 e, 5.1 g 10.1
5.1 e, 5.2 10.2
5.1 f 10.3
5

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SIST EN ISO 8537:2016
EN ISO 8537:2016 (E)
Clause 7 13.1
Clause 7 13.2
7.2.1, 7.2.2, 7.3, 7.4, 7.5, 7.6, 7.7 13.3
7.2.1 b, 7.3 e, 7.4 g 13.4
13.6 The information is provided on
7.4, 7.5, 7.6 the packaging and no additional
instruction for use is required
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
6

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SIST EN ISO 8537:2016
INTERNATIONAL ISO
STANDARD 8537
Third edition
2016-03-15
Sterile single-use syringes, with or
without needle, for insulin
Seringues à insuline, stériles, non réutilisables, avec ou sans aiguille
Reference number
ISO 8537:2016(E)
©
ISO 2016

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SIST EN ISO 8537:2016
ISO 8537:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved

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SIST EN ISO 8537:2016
ISO 8537:2016(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Types of syringes . 5
5 Requirements . 5
5.1 General requirements . 5
5.2 Material selection . 6
5.3 Colour coding . 6
5.4 Extraneous matter . 7
5.4.1 General. 7
5.4.2 Limits for acidity or alkalinity . 7
5.4.3 Limits for extractable metals. 7
5.5 Lubrication . 7
5.5.1 Lubrication of syringes . 7
5.5.2 Lubrication of needle tube . 8
5.6 Dimensions . 8
5.6.1 Barrel and plunger stopper . 8
5.6.2 Finger grips . 8
5.7 Plunger/plunger stopper . 8
5.7.1 General. 8
5.7.2 Fit of plunger stopper in barrel . 8
5.8 Nozzle. 8
5.8.1 Conical fitting . 8
5.8.2 Position of nozzle on end of barrel . . 8
5.9 Needle tubing and needles . 9
5.9.1 Needles for syringe types 3 and 4 . 9
5.9.2 Needle tubing for syringe types 5, 6, 7 and 8 . 9
5.9.3 Bond between hub and needle tube . 9
5.10 Standard test environmental conditions . 9
5.11 Performance of assembled syringe . 9
5.11.1 Dead space . 9
5.11.2 Freedom from leakage at needle .10
5.11.3 Freedom from leakage past plunger stopper .10
6 Packaging .10
6.1 Unit packaging and self-contained syringe units .10
6.1.1 General.10
6.1.2 Unit packaging providing sterile barrier syringes (types 1, 3, 5 and 7) .10
6.1.3 Self-contained syringes with sterile interiors (types 2, 4, 6 and 8) .10
6.2 Multiple-unit packaging (for syringe types 2, 4, 6 and 8) .11
6.3 User packaging .11
7 Information supplied by the manufacturer .11
7.1 General .11
7.2 Syringes .11
7.2.1 General.11
7.2.2 Additional marking for self-contained syringes (syringe types 2, 4, 6 and 8) .12
7.3 Unit packaging (for syringe types 1, 3, 5 and 7) .12
7.4 Multiple unit packs (syringe types 2, 4, 6 and 8) .12
7.5 User packaging .13
7.6 Storage container .14
7.7 Transport wrapping .14
© ISO 2016 – All rights reserved iii

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SIST EN ISO 8537:2016
ISO 8537:2016(E)

Annex A (normative) Fluid for determination of acidity/alkalinity and extractable metals .15
Annex B (normative) Test method for air leakage past syringe piston during aspiration and
for separation of rubber stopper and plunger .16
Annex C (normative) Test method for determination of forces required to operate piston .18
Annex D (normative) Test method for determination of dead space .20
Annex E (normative) Test method for liquid leakage at syringe piston and syringe nozzle/
hub or needle/barrel unions during compression .21
Annex F (normative) Test method for air leakage past nozzle/hub or needle/barrel unions
during aspiration .23
Annex G (normative) Preparation of extract for test for pyrogenicity and toxicity .24
Annex H (normative) Syringe sizes and graduated scales .25
Bibliography .27
iv © ISO 2016 – All rights reserved

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SIST EN ISO 8537:2016
ISO 8537:2016(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.
The committee responsible for this document is ISO/TC 84, Devices for administration of medicinal
products and catheters.
This third edition cancels and replaces the second edition (ISO 8537:2007), which has been technically
revised to include the following changes:
a) revised the introduction;
b) revised the scope to include various concentrations of insulin, specified plastic materials and
excluded, e.g. single-use syringes made of glass;
c) added some normative references;
d) added new definitions;
e) added new colour codes for higher concentration of insulin;
f) clarified the drawing to illustrate the component of the syringe;
g) included general requirements;
h) revised test methods for syringes;
i) revised the labelling requirement;
j) moved the syringe sizes and graduated scales in Annex H;
k) deleted Annex I.
© ISO 2016 – All rights reserved v

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SIST EN ISO 8537:2016
ISO 8537:2016(E)

Introduction
This International Standard covers insulin syringes primarily intended for human use and provides
performance and testing requirements. It permits broader variation in design so as to not limit
innovation in technology or methods of packaging. Its appearance and layout are consistent with
other TC 84 International Standards, which are designed to be more performance-based than design-
prescriptive.
Manufacturers are expected to follow a risk-based approach and employ usability engineering during
the design, development and manufacture of insulin syringes.
This edition introduces general requirements as design guidelines for manufacturers. This edition
retains a number of limits on requirements, which were originally based on consensus opinion but
subsequently have been confirmed in practice.
This International Standard does not specify materials to be used for the construction and lubrication
of sterile insulin syringes and needles for single use because their selection will depend, to some extent,
upon the manufacturer’s specific syringe design, process of manufacture, and sterilization method.
Insulin syringes and needles are to be manufactured and sterilized in accordance with recognized
national or international codes of good manufacturing practice for medical devices.
This International Standard emphasizes the importance of having individual syringes that are
appropriately graduated and labelled for only one concentration of insulin. Serious problems can
result if a syringe is used with a concentration of insulin that is different from the one for which it was
designed. Hazards associated with dosing errors with highly concentrated insulin (U300 and U500) are
considered higher than the experience with U40 and U100.
It is preferred that when more than one insulin concentration is in a market, the new concentration be
provided in a dedicated delivery system that make miss-dosing less likely.
In acknowledgement that insulin in higher concentrations in vials are available in some markets, new
formulations are under development and dedicated delivery systems other than syringes are not always
appropriate for all markets, this International Standard introduces new colour codes to differentiate
syringes for the new higher concentrations of insulin.
The sampling plans for inspection selected for this International Standard are intended to verify the
design at a high confidence level. The sampling plans for inspection do not replace the more general
manufacturing quality systems that appear in standards on quality systems, for example, the ISO 9000
series and ISO 13485.
Guidance on transition periods for implementing the requirements of this International Standard is
given in ISO/TR 19244, developed by ISO/TC 84.
vi © ISO 2016 – All rights reserved

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SIST EN ISO 8537:2016
INTERNATIONAL STANDARD ISO 8537:2016(E)
Sterile single-use syringes, with or without needle, for
insulin
1 Scope
This International Standard specifies requirements and test methods for empty, sterile, single-use
syringes, with or without needles, made of plastic materials and intended solely for the injection of
insulin, with which the syringes are filled by the end user. This International Standard covers syringes
intended for single-use only in humans and with insulins of various concentrations.
The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection)
immediately after filling and are not intended to contain insulin for extended periods of time.
This International Standard excludes single-use syringes made of glass, syringes for use with power-
driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be
stored after filling (e.g. in a kit intended for filling by a pharmacist).
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
1)
ISO 594-1 , Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 1: General requirements
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 7864, Sterile hypodermic needles for single use
ISO 9626, Stainless steel needle tubing for the manufacture of medical devices
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11608–1, Needle-based injection systems for medical use — Requirements and test methods — Part 1:
Needle-based injection systems
ISO 11608–5, Needle-based injection systems for medical use — Requirements and test methods — Part 5:
Automated functions
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1:2012, Medical devices — Sy
...