SIST EN ISO 7886-1:2018
(Main)Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017, Corrected version 2019-08)
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017, Corrected version 2019-08)
This document specifies requirements and test methods for verifying the design of empty sterile singleuse
hypodermic syringes, with or without needle, made of plastic or other materials and intended for
the aspiration and injection of fluids after filling by the end-users. This document does not provide
requirements for lot release. The syringes are primarily for use in humans.
Sterile syringes specified in this document are intended for use immediately after filling and are not
intended to contain the medicament for extended periods of time.
It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for
use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended
to be stored after filling (e.g. in a kit for filling by a pharmacist).
Hypodermic syringes without a needle specified in this document are intended for use with hypodermic
needles specified in ISO 7864.
Sterile Einmalspritzen für medizinische Zwecke - Teil 1: Spritzen zum manuellen Gebrauch (ISO 7886-1:2017, korrigierte Fassung 2019-08)
Dieses Dokument legt Anforderungen an und Prüfverfahren für die Verifizierung der Auslegung leerer steriler Einmalspritzen für medizinische Zwecke aus Kunststoff und anderen Werkstoffen mit oder ohne Kanüle fest, die für das Ansaugen und die Injektion von Flüssigkeiten nach dem Füllen durch die Endanwender vorgesehen sind. Dieses Dokument enthält keine Anforderungen an die Losfreigabe. Die Spritzen sind vorwiegend für die Anwendung beim Menschen vorgesehen.
Die in diesem Dokument festgelegten sterilen Spritzen sind für den Einsatz unmittelbar nach dem Füllen vorgesehen und sind nicht dafür vorgesehen, über einen längeren Zeitraum mit dem Arzneimittel gefüllt zu sein.
Ausgenommen sind Insulinspritzen (siehe ISO 8537), Einmalspritzen aus Glas, Spritzen für Druckinfusionsapparate, durch den Hersteller vorgefüllte Spritzen sowie Spritzen, die für die Lagerung nach dem Füllen vorgesehen sind (z. B. Beilagespritzen, die vom Apotheker gefüllt werden).
Spritzen für medizinische Zwecke ohne Kanüle nach diesem Dokument sind für den Einsatz mit Spritzen für medizinische Zwecke nach ISO 7864 vorgesehen.
Seringues hypodermiques stériles, non réutilisables - Partie 1: Seringues pour utilisation manuelle (ISO 7886-1:2017, Version corrigée 2019-08)
ISO 7886-1:2017 fixe les exigences et les méthodes d'essai relatives à la vérification de la conception des seringues hypodermiques stériles non réutilisables vides, avec ou sans aiguille, constituées de matières plastiques ou d'autres matières et destinées à l'aspiration et à l'injection de liquides après remplissage par les utilisateurs finaux. Le présent document ne spécifie pas d'exigences applicables à la libération des lots. Les seringues sont destinées en premier lieu à l'Homme.
Les seringues stériles spécifiées dans le présent document sont prévues pour être utilisées immédiatement après leur remplissage et ne sont pas destinées à contenir le médicament pendant de longues périodes.
Il exclut les seringues utilisables avec de l'insuline (voir l'ISO 8537), les seringues non réutilisables en verre, les seringues pour pousse-seringues mus par un moteur, les seringues pré-remplies par le fabricant et les seringues prévues pour être conservées après leur remplissage (par exemple dans un kit prévu pour être rempli par un pharmacien).
Les seringues hypodermiques sans aiguille spécifiées dans le présent document sont destinées à être utilisées avec les aiguilles hypodermiques indiquées dans l'ISO 7864.
Sterilne podkožne injekcijske brizge za enkratno uporabo - 1. del: Injekcijske brizge za ročno injiciranje (ISO 7886-1:2017, popravljena verzija 2019-08)
Ta dokument določa zahteve in preskusne metode za preverjanje zasnove praznih sterilnih podkožnih injekcijskih brizg z iglo ali brez nje, izdelanih iz plastike ali drugih materialov, ki so namenjene za aspiracijo in injiciranje tekočin, s katerimi jih napolni končni uporabnik. Ta dokument ne podaja zahtev za izdajo serij. Injekcijske brizge so namenjene predvsem za uporabo pri ljudeh.
Sterilne injekcijske brizge, ki so določene v tem dokumentu, so namenjene za uporabo takoj po polnjenju in ne smejo vsebovati zdravila dalj časa.
V tem dokumentu niso zajete injekcijske brizge za inzulin (glej standard ISO 8537), steklene injekcijske brizge za enkratno uporabo, injekcijske brizge za uporabo z injekcijskimi črpalkami, injekcijske brizge, ki jih predhodno napolni proizvajalec, in injekcijske brizge, ki so namenjene za shranjevanje po polnjenju (npr. v kompletu, ki ga napolni farmacevt).
Podkožne injekcijske brizge brez igle, ki so navedene v tem dokumentu, so namenjene za uporabo s podkožnimi
iglami, ki so navedene v standardu ISO 7864.
General Information
Relations
Buy Standard
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 7886-1:2018
01-junij-2018
Nadomešča:
SIST EN ISO 7886-1:2000
Sterilne podkožne injekcijske brizge za enkratno uporabo - 1. del: Injekcijske
brizge za ročno injiciranje (ISO 7886-1:2017, popravljena verzija 2019-08)
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-
1:2017, Corrected version 2019-08)
Sterile Einmalspritzen für medizinische Zwecke - Teil 1: Spritzen zum manuellen
Gebrauch (ISO 7886-1:2017, korrigierte Fassung 2019-08)
Seringues hypodermiques stériles, non réutilisables - Partie 1: Seringues pour utilisation
manuelle (ISO 7886-1:2017, Version corrigée 2019-08)
Ta slovenski standard je istoveten z: EN ISO 7886-1:2018
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 7886-1:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 7886-1:2018
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SIST EN ISO 7886-1:2018
EN ISO 7886-1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2018
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 7886-1:1997
English Version
Sterile hypodermic syringes for single use - Part 1:
Syringes for manual use (ISO 7886-1:2017, Corrected
version 2019-08)
Seringues hypodermiques stériles, non réutilisables - Sterile Einmalspritzen für medizinische Zwecke - Teil
Partie 1: Seringues pour utilisation manuelle (ISO 1: Spritzen zum manuellen Gebrauch (ISO 7886-
7886-1:2017, Version corrigée 2019-08) 1:2017)
This European Standard was approved by CEN on 28 February 2017.
This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 09 October 2019.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N
EUROPÄISCHES KOMITEE FÜR NORMUN G
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7886-1:2018 E
worldwide for CEN national Members.
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SIST EN ISO 7886-1:2018
EN ISO 7886-1:2018 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
2
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SIST EN ISO 7886-1:2018
EN ISO 7886-1:2018 (E)
European foreword
This document (EN ISO 7886-1:2017) 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 September 2018, and conflicting national standards
shall be withdrawn at the latest by September 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 7886-1:1997.
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.
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.
Table 1 — Correlation between normative references and dated EN and ISO standards
Normative references as listed Equivalent dated standard
in Clause 2 of the ISO standard
EN ISO or IEC
ISO 15223-1:2016 EN ISO 15223-1:2016 ISO 15223-1:2016
ISO 23908 EN ISO 23908:2013 ISO 23908:2011
ISO 80369-7 EN ISO 80369-7:2017 ISO 80369-7:2016
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
3
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SIST EN ISO 7886-1:2018
EN ISO 7886-1:2018 (E)
Endorsement notice
The text of ISO 7886-1:2017, Corrected version 2019-08 has been approved by CEN as EN ISO 7886-
1:2018 without any modification.
4
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SIST EN ISO 7886-1:2018
EN ISO 7886-1:2018 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European standard has been prepared under a Commission’s standardisation request M/295
concerning the development of European Standards related to medical devices to provide one voluntary
means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993
concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
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 Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/subclause(s) of Remarks/Notes
Directive 93/42/EEC this EN
7.3 6.2 Standard Clause 6.2 meets ER
7.3 in respect of the device
altering the pH of the
contents of the device.
7.5 13.2 Standard Clause 13.2 covers
ER 7.5 only in respect of
leakage past the plunger.
7.6 14.1.1, 14.1.2 Standard Clause 14.1.1 meets
ER 7.6 in respect of
packaging only.
Standard Clause 14.1.2 meets
the ER 7.6 up to the point of
use.
5
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SIST EN ISO 7886-1:2018
EN ISO 7886-1:2018 (E)
Essential Requirements of Clause(s)/subclause(s) of Remarks/Notes
Directive 93/42/EEC this EN
8.3 14.1.1, 14.1.2
9.2 5, 6, 10, 11 Standard Clauses 5, 6, 10 and
11 meet ER 9.2 for the
aspects detailed in the
Standard Clauses.
10.1 8, 9.4, 11.2 Standard Clause 8 meets ER
10.1 except for the last
sentence.
Standard Clauses 9.4 and
11.2 meet the requirements
of ER 10.1 as they relates to
the relationship between the
zero graduation line of the
scale and the fiducial line on
the plunger stopper only.
10.2 9.1, 9.2
10.3 15.2.1 b)
13.1 15
13.3 (a) 15.2.2 b), 15.3 f), 15.4.1 b),
15.5 e)
13.3 (b) 15.3 e), 15.4.1 e), 15.5 f), 15.6
a)
13.3 (c) 15.3 a), 15.4.2 a), 15.5 a), 15.5
b), 15.6 c)
13.3 (d) 15.3 c), 15.4.1 c), 15.5 d), 15.6
b)
13.3 (e) 15.3 g), 15.4.1 f), 15.5 g), 15.6
f)
13.3 (f) 15.2.2 a), 15.3 b), 15.4.1 a),
15.5 c)
13.3 (i) 15.6 e)
13.3 (k) 15.4.2 b)
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
6
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SIST EN ISO 7886-1:2018
INTERNATIONAL ISO
STANDARD 7886-1
Second edition
2017-05
Corrected version
2019-08
Sterile hypodermic syringes for
single use —
Part 1:
Syringes for manual use
Seringues hypodermiques stériles, non réutilisables —
Partie 1: Seringues pour utilisation manuelle
Reference number
ISO 7886-1:2017(E)
©
ISO 2017
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SIST EN ISO 7886-1:2018
ISO 7886-1:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2017 – All rights reserved
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SIST EN ISO 7886-1:2018
ISO 7886-1:2017(E)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Nomenclature . 3
5 General requirements . 5
6 Extraneous matter . 5
6.1 General . 5
6.2 Limits for acidity or alkalinity . 5
6.3 Limits for extractable metals . 5
7 Lubricant . 6
8 Tolerance on graduated capacity . 6
9 Graduated scale . 7
9.1 Scale . 7
9.2 Numbering of scales . 8
9.3 Overall length of scale to nominal capacity line . 8
9.4 Position of scale . 9
10 Barrel . 9
10.1 Dimensions . 9
10.2 Barrel flanges . 9
11 Plunger stopper/plunger assembly. 9
11.1 Design . 9
12 Nozzle .10
12.1 Conical fitting .10
12.2 Position of nozzle on end of barrel .10
12.3 Nozzle lumen .10
13 Performance .10
13.1 Dead space .10
13.2 Freedom from air and liquid leakage past plunger stopper .10
13.3 Force to operate the piston.10
13.4 Fit of plunger stopper/plunger in barrel .10
14 Packaging .11
14.1 Unit packaging and self-contained syringe units .11
14.1.1 Unit packaging .11
14.1.2 Self-contained syringe units .11
14.2 Multiple unit pack.11
14.3 User packaging .11
15 Information supplied by the manufacturer .12
15.1 General .12
15.2 Syringes .12
15.2.1 General.12
15.2.2 Additional marking for self-contained syringe units.12
15.3 Unit packaging .12
15.4 Multiple unit packs .13
15.4.1 General.13
15.4.2 Multiple unit packs with self-contained syringes.13
15.5 User packaging .13
© ISO 2017 – All rights reserved iii
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SIST EN ISO 7886-1:2018
ISO 7886-1:2017(E)
15.6 Storage container .14
15.7 Transport wrapping .14
Annex A (normative) Method for preparation of extracts .15
Annex B (normative) Test method for air leakage past syringe plunger stopper during
aspiration, and for separation of plunger stopper and plunger .16
Annex C (normative) Method for determination of dead space .18
Annex D (normative) Test method for liquid leakage at syringe plunger stopper under
compression .19
Annex E (informative) Test method for the determination of forces required to operate the
piston .21
Annex F (informative) Test method for the quantity of silicone .25
Bibliography .28
iv © ISO 2017 – All rights reserved
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SIST EN ISO 7886-1:2018
ISO 7886-1:2017(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 voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical committee ISO/TC 84, Devices for administration of medicinal
products and catheters.
This second edition cancels and replaces the first edition (ISO 7886-1:1993), which has been technically
revised. It also incorporates the Technical corrigendum ISO 7886-1:1993/Cor.1:1995.
The main changes to the previous edition are the following:
a) clarified the Scope, e.g. excluding single-use syringes made of glass;
b) added new Normative references;
c) added new terms and definitions;
d) clarified the drawing to illustrate the component of the syringe;
e) included general requirements;
f) revised test methods for syringes;
g) revised the labelling requirement;
h) clarified the type of lubricant for the different types of syringes;
i) replaced Annex E (informative): Examples of test methods for incompatibility between syringes
and injection fluids with Annex E (informative): Test method for the determination of forces
required to operate the piston;
j) added Annex F (informative): Test method for the quantity of silicone;
k) informative annex on materials has been deleted.
A list of all parts in the ISO 7886 series can be found on the ISO website.
© ISO 2017 – All rights reserved v
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SIST EN ISO 7886-1:2018
ISO 7886-1:2017(E)
This corrected version of ISO 7886-1:2017 incorporates the following corrections:
— In the key to Figure E.1, item 2 was corrected to read "needle [1,2 mm (18 G) and approximately
40 mm length";
— In the key to Figure E.1, item 3 was corrected to read " tubing [(2,7 ± 0,1) mm i.d. and (500 ± 5) mm
in length with male and female Luer adapters at each end)]";
— In E.2.3, the value "(19,5 ± 0,5) cm" was changed to "(500 ± 5) mm".
vi © ISO 2017 – All rights reserved
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SIST EN ISO 7886-1:2018
ISO 7886-1:2017(E)
Introduction
The ISO 7886 series covers hypodermic syringes primarily intended for human use and provides
performance and testing requirements. It permits broader variation in design so as not to limit
innovation and methods of packaging. Its appearance and layout are consistent with other related
standards which are designed to be more performance-based compared to design prescriptive.
General requirements as design guidelines for manufacturers are introduced in this document. Several
limits for requirements which are historic based but confirmed in practice for many years have been kept.
Materials to be used for the construction and lubrication of sterile syringes 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. The materials of the syringe should be
compatible with injection fluids. If this is not the case, the attention of the user should be drawn to the
exception by labelling on unit packaging. It is not practicable to specify a universally acceptable test
method for incompatibility, as the only conclusive test is that an individual specific injection fluid is
compatible with a specific syringe.
Manufacturers of pharmaceuticals use solvents in injectable preparations. Such solvents should be
tested by the manufacturer of the injectable preparation for any possible incompatibility with the
materials frequently used in syringe construction. If an incompatibility is identified, the injection
fluid should be suitably labelled. The impossibility of testing any one injection fluid with all available
syringes is recognized and it is strongly recommended that regulatory authorities and relevant trade
associations should recognize the problem and take appropriate measures to assist manufacturers of
injectable preparations.
Syringes should be manufactured and sterilized in accordance with recognized national or international
codes of good manufacturing practice for medical devices.
The sampling plans for inspection selected for the ISO 7886 series are intended to verify the design at a
high confidence level. The sampling p
...
SLOVENSKI STANDARD
SIST EN ISO 7886-1:2018
01-junij-2018
1DGRPHãþD
SIST EN ISO 7886-1:2000
6WHULOQHSRGNRåQHLQMHNFLMVNHEUL]JH]DHQNUDWQRXSRUDERGHO ,QMHNFLMVNH
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Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-
1:2017)
Sterile Einmalspritzen für medizinische Zwecke - Teil 1: Spritzen zum manuellen
Gebrauch (ISO 7886-1:2017)
Seringues hypodermiques stériles, non réutilisables - Partie 1: Seringues pour utilisation
manuelle (ISO 7886-1:2017)
Ta slovenski standard je istoveten z: EN ISO 7886-1:2018
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 7886-1:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 7886-1:2018
---------------------- Page: 2 ----------------------
SIST EN ISO 7886-1:2018
EN ISO 7886-1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2018
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 7886-1:1997
English Version
Sterile hypodermic syringes for single use - Part 1:
Syringes for manual use (ISO 7886-1:2017)
Seringues hypodermiques stériles, non réutilisables - Sterile Einmalspritzen für medizinische Zwecke - Teil
Partie 1: Seringues pour utilisation manuelle (ISO 1: Spritzen zum manuellen Gebrauch (ISO 7886-
7886-1:2017) 1:2017)
This European Standard was approved by CEN on 28 February 2017.
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, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7886-1:2018 E
worldwide for CEN national Members.
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SIST EN ISO 7886-1:2018
EN ISO 7886-1:2018 (E)
Contents Page
European foreword . 3
Endorsement notice . 4
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
2
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SIST EN ISO 7886-1:2018
EN ISO 7886-1:2018 (E)
European foreword
This document (EN ISO 7886-1:2017) 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 September 2018, and conflicting national standards
shall be withdrawn at the latest by September 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 7886-1:1997.
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.
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.
Table 1 — Correlation between normative references and dated EN and ISO standards
Normative references as listed Equivalent dated standard
in Clause 2 of the ISO standard
EN ISO or IEC
ISO 15223-1:2016 EN ISO 15223-1:2016 ISO 15223-1:2016
ISO 23908 EN ISO 23908:2013 ISO 23908:2011
ISO 80369-7 EN ISO 80369-7:2017 ISO 80369-7:2016
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
3
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SIST EN ISO 7886-1:2018
EN ISO 7886-1:2018 (E)
Endorsement notice
The text of ISO 7886-1:2017 has been approved by CEN as EN ISO 7886-1:2018 without any
modification.
4
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SIST EN ISO 7886-1:2018
EN ISO 7886-1:2018 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European standard has been prepared under a Commission’s standardisation request M/295
concerning the development of European Standards related to medical devices to provide one voluntary
means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993
concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
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 Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/subclause(s) of Remarks/Notes
Directive 93/42/EEC this EN
7.3 6.2 Standard Clause 6.2 meets ER
7.3 in respect of the device
altering the pH of the
contents of the device.
7.5 13.2 Standard Clause 13.2 covers
ER 7.5 only in respect of
leakage past the plunger.
7.6 14.1.1, 14.1.2 Standard Clause 14.1.1 meets
ER 7.6 in respect of
packaging only.
Standard Clause 14.1.2 meets
the ER 7.6 up to the point of
use.
5
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SIST EN ISO 7886-1:2018
EN ISO 7886-1:2018 (E)
Essential Requirements of Clause(s)/subclause(s) of Remarks/Notes
Directive 93/42/EEC this EN
8.3 14.1.1, 14.1.2
9.2 5, 6, 10, 11 Standard Clauses 5, 6, 10 and
11 meet ER 9.2 for the
aspects detailed in the
Standard Clauses.
10.1 8, 9.4, 11.2 Standard Clause 8 meets ER
10.1 except for the last
sentence.
Standard Clauses 9.4 and
11.2 meet the requirements
of ER 10.1 as they relates to
the relationship between the
zero graduation line of the
scale and the fiducial line on
the plunger stopper only.
10.2 9.1, 9.2
10.3 15.2.1 b)
13.1 15
13.3 (a) 15.2.2 b), 15.3 f), 15.4.1 b),
15.5 e)
13.3 (b) 15.3 e), 15.4.1 e), 15.5 f), 15.6
a)
13.3 (c) 15.3 a), 15.4.2 a), 15.5 a), 15.5
b), 15.6 c)
13.3 (d) 15.3 c), 15.4.1 c), 15.5 d), 15.6
b)
13.3 (e) 15.3 g), 15.4.1 f), 15.5 g), 15.6
f)
13.3 (f) 15.2.2 a), 15.3 b), 15.4.1 a),
15.5 c)
13.3 (i) 15.6 e)
13.3 (k) 15.4.2 b)
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
6
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SIST EN ISO 7886-1:2018
INTERNATIONAL ISO
STANDARD 7886-1
Second edition
2017-05
Sterile hypodermic syringes for
single use —
Part 1:
Syringes for manual use
Seringues hypodermiques stériles, non réutilisables —
Partie 1: Seringues pour utilisation manuelle
Reference number
ISO 7886-1:2017(E)
©
ISO 2017
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SIST EN ISO 7886-1:2018
ISO 7886-1:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, 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 2017 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 7886-1:2018
ISO 7886-1:2017(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Nomenclature . 3
5 General requirements . 5
6 Extraneous matter . 5
6.1 General . 5
6.2 Limits for acidity or alkalinity . 5
6.3 Limits for extractable metals . 5
7 Lubricant . 6
8 Tolerance on graduated capacity . 6
9 Graduated scale . 7
9.1 Scale . 7
9.2 Numbering of scales . 8
9.3 Overall length of scale to nominal capacity line . 8
9.4 Position of scale . 9
10 Barrel . 9
10.1 Dimensions . 9
10.2 Barrel flanges . 9
11 Plunger stopper/plunger assembly. 9
11.1 Design . 9
12 Nozzle .10
12.1 Conical fitting .10
12.2 Position of nozzle on end of barrel .10
12.3 Nozzle lumen .10
13 Performance .10
13.1 Dead space .10
13.2 Freedom from air and liquid leakage past plunger stopper .10
13.3 Force to operate the piston.10
13.4 Fit of plunger stopper/plunger in barrel .10
14 Packaging .11
14.1 Unit packaging and self-contained syringe units .11
14.1.1 Unit packaging .11
14.1.2 Self-contained syringe units .11
14.2 Multiple unit pack.11
14.3 User packaging .11
15 Information supplied by the manufacturer .12
15.1 General .12
15.2 Syringes .12
15.2.1 General.12
15.2.2 Additional marking for self-contained syringe units.12
15.3 Unit packaging .12
15.4 Multiple unit packs .13
15.4.1 General.13
15.4.2 Multiple unit packs with self-contained syringes.13
15.5 User packaging .13
© ISO 2017 – All rights reserved iii
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SIST EN ISO 7886-1:2018
ISO 7886-1:2017(E)
15.6 Storage container .14
15.7 Transport wrapping .14
Annex A (normative) Method for preparation of extracts .15
Annex B (normative) Test method for air leakage past syringe plunger stopper during
aspiration, and for separation of plunger stopper and plunger .16
Annex C (normative) Method for determination of dead space .18
Annex D (normative) Test method for liquid leakage at syringe plunger stopper
under compression .19
Annex E (informative) Test method for the determination of forces required to operate
the piston .21
Annex F (informative) Test method for the quantity of silicone .25
Bibliography .28
iv © ISO 2017 – All rights reserved
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SIST EN ISO 7886-1:2018
ISO 7886-1:2017(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 voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by Technical committee ISO/TC 84, Devices for administration of medicinal
products and catheters.
This second edition cancels and replaces the first edition (ISO 7886-1:1993), which has been technically
revised. It also incorporates the Technical corrigendum ISO 7886-1:1993/Cor.1:1995.
The main changes to the previous edition are the following:
a) clarified the Scope, e.g. excluding single-use syringes made of glass;
b) added new Normative references;
c) added new terms and definitions;
d) clarified the drawing to illustrate the component of the syringe;
e) included general requirements;
f) revised test methods for syringes;
g) revised the labelling requirement;
h) clarified the type of lubricant for the different types of syringes;
i) replaced Annex E (informative): Examples of test methods for incompatibility between syringes
and injection fluids with Annex E (informative): Test method for the determination of forces
required to operate the piston;
j) added Annex F (informative): Test method for the quantity of silicone;
k) informative annex on materials has been deleted.
A list of all parts in the ISO 7886 series can be found on the ISO website.
© ISO 2017 – All rights reserved v
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SIST EN ISO 7886-1:2018
ISO 7886-1:2017(E)
Introduction
The ISO 7886 series covers hypodermic syringes primarily intended for human use and provides
performance and testing requirements. It permits broader variation in design so as not to limit
innovation and methods of packaging. Its appearance and layout are consistent with other related
standards which are designed to be more performance-based compared to design prescriptive.
General requirements as design guidelines for manufacturers are introduced in this document. Several
limits for requirements which are historic based but confirmed in practice for many years have been kept.
Materials to be used for the construction and lubrication of sterile syringes 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. The materials of the syringe should be
compatible with injection fluids. If this is not the case, the attention of the user should be drawn to the
exception by labelling on unit packaging. It is not practicable to specify a universally acceptable test
method for incompatibility, as the only conclusive test is that an individual specific injection fluid is
compatible with a specific syringe.
Manufacturers of pharmaceuticals use solvents in injectable preparations. Such solvents should be
tested by the manufacturer of the injectable preparation for any possible incompatibility with the
materials frequently used in syringe construction. If an incompatibility is identified, the injection
fluid should be suitably labelled. The impossibility of testing any one injection fluid with all available
syringes is recognized and it is strongly recommended that regulatory authorities and relevant trade
associations should recognize the problem and take appropriate measures to assist manufacturers of
injectable preparations.
Syringes should be manufactured and sterilized in accordance with recognized national or international
codes of good manufacturing practice for medical devices.
The sampling plans for inspection selected for the ISO 7886 series 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 requirements that appear in standards on quality systems, for example the ISO 9000
series and ISO 13485.
Manufacturers are expected to follow a risk-based approach and employ usability engineering during
the design, development and manufacture of syringes.
Guidance on transition periods for implementing the requirements of ISO 7886 (all parts) is given in
ISO/TR 19244.
vi © ISO 2017 – All rights reserved
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SIST EN ISO 7886-1:2018
INTERNATIONAL STANDARD ISO 7886-1:2017(E)
Sterile hypodermic syringes for single use —
Part 1:
Syringes for manual use
1 Scope
This document specifies requirements and test methods for verifying the desig
...
SLOVENSKI STANDARD
oSIST prEN ISO 7886-1:2015
01-november-2015
6WHULOQHSRGNRåQHLQMHNFLMVNHEUL]JH]DHQNUDWQRXSRUDERGHO ,QMHNFLMVNH
EUL]JH]DURþQRLQMLFLUDQMH ,62',6
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO/DIS
7886-1:2015)
Sterile Einmalspritzen für medizinische Zwecke - Teil 1: Spritzen zum manuellen
Gebrauch (ISO/DIS 7886-1:2015)
Seringues hypodermiques stériles, non réutilisables - Partie 1: Seringues pour utilisation
manuelle (ISO/DIS 7886-1:2015)
Ta slovenski standard je istoveten z: FprEN ISO 7886-1 rev
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 7886-1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 7886-1:2015
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oSIST prEN ISO 7886-1:2015
DRAFT INTERNATIONAL STANDARD
ISO/DIS 7886-1
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2015-09-10 2015-12-10
Sterile hypodermic syringes for single use —
Part 1:
Syringes for manual use
Seringues hypodermiques stériles, non réutilisables —
Partie 1: Seringues pour utilisation manuelle
ICS: 11.040.25
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 7886-1:2015(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2015
---------------------- Page: 3 ----------------------
oSIST prEN ISO 7886-1:2015
ISO/DIS 7886-1:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, 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 2015 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 7886-1:2015
ISO/DIS 7886-1
Contents Page
Foreword . vi
Introduction . viii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Nomenclature . 3
5 General requirements . 4
6 Extraneous matter . 4
6.1 Limits for acidity or alkalinity . 4
6.2 Limits for extractable metals . 5
7 Lubricant . 5
8 Tolerance on graduated capacity . 5
9 Graduated scale . 6
9.1 Scale . 6
9.2 Numbering of scale . 7
9.3 Overall length of scale to nominal capacity line . 7
9.4 Position of scale . 7
10 Barrel . 8
10.1 Dimensions . 8
10.2 Finger grips . 8
11 Plunger stopper/plunger assembly . 8
11.1 Design . 8
11.2 Fit of plunger stopper in barrel . 8
11.3 Fiducial line . 8
12 Nozzle . 8
12.1 Conical fitting . 8
12.2 Position of nozzle on end of barrel . 9
12.3 Nozzle lumen . 9
13 Performance . 9
13.1 Dead space . 9
13.2 Freedom from air and liquid leakage past plunger stopper . 9
14 Packaging . 9
14.1 Unit packaging and self-contained syringe units . 9
14.1.1 General . 9
14.1.2 Unit packaging providing sterile barrier . 9
14.1.3 Self-contained syringe units interior sterile . 10
14.2 Multiple unit pack . 10
14.3 User packaging . 10
15 Information supplied by the manufacturer . 10
15.1 General . 10
15.2 Syringes. 10
15.2.1 General . 10
15.2.2 Additional marking for self-contained syringe units . 10
15.3 Unit packaging . 11
© ISO 2015 – All rights reserved iii
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oSIST prEN ISO 7886-1:2015
ISO/DIS 7886-1
15.4 Multiple unit packs. 11
15.5 User packaging . 12
15.6 Storage container . 13
15.7 Transport wrapping . 13
Annex A (normative) Method for preparation of extracts . 14
A.1 Principle . 14
A.2 Apparatus and reagents . 14
A.3 Procedure . 14
Annex B (normative) Test method for air leakage past syringe plunger stopper during aspiration,
and for separation of plunger stopper and plunger . 15
B.1 Principle . 15
B.2 Apparatus and reagents . 15
B.3 Procedure . 15
B.4 Test report . 15
Annex C (normative) Method for determination of dead space . 18
C.1 Principle . 18
C.2 Apparatus and reagents . 18
C.3 Procedure . 18
C.4 Calculation of results . 18
C.5 Test report . 18
Annex D (normative) Test method for liquid leakage at syringe plunger stopper under
compression . 19
D.1 Principle . 19
D.2 Apparatus and reagents . 19
D.3 Procedure . 19
D.4 Test report . 19
Annex E (informative) Examples of test methods for incompatibility between syringes and
injection fluids . 21
E.1 General . 21
E.2 Matrix of tests . 21
E.3 Test fluids . 22
E.4 Apparatus and reagents . 22
E.5 Procedure for preparation of extracts . 23
E.6 Test procedures . 23
E.6.1 General . 23
E.6.2 Visual examination . 23
E.6.3 Organoleptic (odour) examination . 23
E.6.4 Reducing substances . 24
E.6.5 Spectrophotometry . 24
E.6.6 Resistivity . 24
E.6.7 Ease of plunger movement . 25
E.7 Test report . 25
Annex F (normative) Test method for forces required to operate plunger . 26
F.1 Principle . 26
F.2 Apparatus and reagents . 26
F.3 Procedure . 27
F.4 Calculation results . 28
F.5 Test report . 29
Annex G (informative) Test method for the quantity of silicone . 30
G.1 Principle . 30
G.2 Apparatus and reagents . 30
G.3 Test procedures . 30
G.3.1 Preparation of standard solution . 30
G.3.2 Preparation of the test solution . 31
G.3.3 Set-up of testing device . 31
G.3.4 Measurement Procedures . 32
iv © ISO 2015 – All rights reserved
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oSIST prEN ISO 7886-1:2015
ISO/DIS 7886-1
G.3.5 Proposed compliance criterion . 32
G.4 Test report . 32
Bibliography . 33
© ISO 2015 – All rights reserved v
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oSIST prEN ISO 7886-1:2015
ISO/DIS 7886-1
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 7886-1 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and catheters.
In some countries national regulations are legally binding and the requirements may take precedence over
this International Standard.
This second edition cancels and replaces the first edition (ISO 7886-1:1993), which has been technically
revised.
ISO 7886 consists of the following parts, under the general title Sterile hypodermic syringes for single use —
Part 1: Syringes for manual use:
Part 1: Syringes for manual use
Part 2: Syringes for use with power-driven syringe pumps
Part 3: Auto-disabled syringes for fixed-dose immunization
Part 4: Syringes with re-use prevention feature
The main changes to the previous edition of ISO 7886-1 introduced by this revision are:
a) Clarified the scope e.g. excluding single-use syringes made of glass
b) Added some Normative references
c) Added new definitions
d) Clarified the drawing to illustrate the component of the syringe
e) Included general requirements
f) Revised test methods for syringes
g) Revised the labelling requirement
vi © ISO 2015 – All rights reserved
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oSIST prEN ISO 7886-1:2015
ISO/DIS 7886-1
h) Clarified the type of lubricant for the different types of syringes
i) Added a new Annex G (informative) Test method for the quantity of silicone
j) Informative annex on materials has been deleted.
© ISO 2015 – All rights reserved vii
---------------------- Page: 9 ----------------------
oSIST prEN ISO 7886-1:2015
ISO/DIS 7886-1
Introduction
This International Standard covers hypodermic syringes primarily intended for human use and provides
performance and testing requirements. It permits broader variation in design so as to not limit innovation and
methods of packaging. Its appearance and layout are consistent with other TC 84 standards which are
designed to be more performance-based compared to design prescriptive.
General requirements as design guidelines for manufacturers are introduced in the edition. A number of limits
for requirements which is historic based but confirmed in practice for many years, have been kept.
Materials to be used for the construction and lubrication of sterile syringes 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. The materials of the syringe should be compatible with injection fluids.
If this is not the case, the attention of the user should be drawn to the exception by labelling unit packaging. It
is practicable to specify a universally acceptable test method for incompatibility. However, recommended
methods are given in Annex E. These test methods can be regarded only as means of indicating compatibility.
The only conclusive test is that of an individual injection fluid with a specific syringe.
Manufacturers of pharmaceuticals use solvents in injectable preparations. Such solvents should be tested by
the manufacturer of the injectable preparation for any possible incompatibility with the materials frequently
used in syringe construction. If an incompatibility is identified, the injection fluid should be suitably labelled.
The impossibility of testing any one injection fluid with all available syringes is recognized and it is strongly
recommended that regulatory authorities and relevant trade associations should recognize the problem and
take appropriate measure to assist manufacturers.
Syringes should be manufactured and sterilized in accordance with recognized national or international codes
of good manufacturing practice for medical devices.
The sampling plans for inspection selected for this 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.
Manufacturers are expected to follow a risk-based approach and employ usability engineering during the
design, development and manufacture of syringes.
Guidance on transition periods for implementing the requirements of this standard is given in ISO/TR 19244
'Guidance on transition periods for standards developed by ISO/TC 84 - Devices for administration of
medicinal products and catheters'.
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oSIST prEN ISO 7886-1:2015
DRAFT INTERNATIONAL STANDARD ISO/DIS 7886-1
Sterile hypodermic syringes for single use — Part 1: Syringes
for manual use
1 Scope
This part of ISO 7886 specifies requirements and test methods for verifying the design of empty sterile single-
use hypodermic syringes, made of plastic materials and intended for the aspiration and injection of fluids after
filling by the end-users. This standard does not provide requirements for lot release. The syringes are
primarily for use in humans.
Sterile syringes specified in this International Standard are intended for use immediately after filling as they
are not suitable for containing fluids over extended periods of time.
lt excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use
with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored
after filling (e.g. in a kit for filling by a pharmacist).
Hypodermic syringes without a needle specified in this part of ISO 7886 are intended for use with hypodermic
needles specified in ISO 7864.
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.
ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment - Part 1: General requirements
ISO 594-2:1998 , Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment - Part 2: Lock fittings
ISO 3696:1987, Water for analytical laboratory use - Specification and test methods
ISO 15223-1, Medical devices - Symbols to be used with medical device labels, labelling and information to be
supplied - Part 1: General requirements
ISO 23908, Sharps injury protection - Requirements and test methods - Sharps protection features for single-
use hypodermic needles, introducers for catheters and needles used for blood sampling
NOTE ISO 594-1;1986 and ISO 594-2:1998 will be replaced by ISO 80369-7.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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oSIST prEN ISO 7886-1:2015
ISO/DIS 7886-1
3.1
nominal capacity
capacity of the syringe as designated by the manufacturer
NOTE 1 to entry: Examples are 1 ml, 5 ml, 50 ml.
3.2
graduated capacity
volume of water at 18 °C to 28 °C expelled from the syringe when the fiducial line on the piston traverses a
given scale interval or intervals
3.3
total graduated capacity
capacity of the syringe at the graduation line furthest from the zero graduation line
NOTE 1 to entry: The total graduated capacity may be equal to, or greater than, the nominal capacity.
3.4
maximum usable capacity
capacity of the syringe when the piston is drawn back to its furthest functional position
3.5
fiducial line
leading edge on the plunger stopper, which is in contact with and perpendicular to the syringe barrel and
aligns with the zero marking on the syringe barrel when the piston is fully inserted
3.6
unit packaging
packaging which has the direct contact with the device and maintains the sterility of the product
3.7
user packaging
packaging designed to contain one or more unit packages or self-contained syringe units
Note 1 to entry: Self-contained syringe units can be packed in multiple unit packs
3.8
two-piece syringe
syringe assembly comprises of the barrel, plunger and plunger stopper, whereas plunger and plunger stopper
form one component made of the same material, that contains a slip additive to allow smooth plunger
movement
3.9
three-piece syringe
syringe assembly includes the barrel, plunger and plunger stopper, whereas plunger and plunger stopper are
two separate components of different material
3.10
nozzle cap
sheath intended to protect physically the needle hub prior to use
3.11
plunger stoppers
component which seals one end of the syringes and interfaces with the plunger
3.13
self-contained syringe
syringe with protective end caps (i.e., plunger cap, and nozzle cap or needle cap) intended to maintain the
sterility of the interior of the syringe
2
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