SIST EN ISO 7886-1:2018

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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

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.
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.
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.
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.
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
ISO 7886-1:2017(E)
© 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

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 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

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 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

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.
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 design of empty sterile single-
use 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 15223-1:2016, 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
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http: //www .electropedia .org/
— ISO Online browsing platform: available at http: //www .iso .org/obp
3.1
nominal capacity
capacity of the syringe as designated by the manufacturer
EXAMPLE 1 ml, 5 ml, 50 ml
ISO 7886-1:2017(E)
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
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 that 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 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 the barrel and piston, whereas plunger and plunger stopper form one
component made of the same material
3.9
three-piece syringe
syringe assembly includes the barrel and piston, whereas plunger and plunger stopper are two separate
components of different materials
3.10
nozzle cap
sheath intended to physically protect the nozzle prior to use
3.11
plunger stopper
component connected to the leading end of the plunger and seals the open end of the syringe barrel
3.12
self-contained syringe
syringe with protective end caps [i.e. plunger cap, and nozzle cap or needle cap (3.17)] intended to
maintain the sterility of the interior of the syringe
3.13
dead space
residual volume of fluid left in syringe when the plunger stopper (3.11) is fully depressed
3.14
multiple unit pack
multiple syringes packaged with a single seal that maintains the sterility of the product
2 © ISO 2017 – All rights reserved

ISO 7886-1:2017(E)
3.15
piston
assembled component of plunger and plunger stopper (3.11)
3.16
barrel flanges
flanges that protrude from the barrel (also referred to as finger grips) to provide the user an ergonomic
means of gripping the syringe during injection
3.17
needle cap or shield
sheath intended to physically protect the needle prior to use
3.18
plunger
device component which advances the plunger stopper (3.11) to deliver the medicinal product
4 Nomenclature
The nomenclature for the components of hypodermic syringes for single use is shown in Figure 1.

ISO 7886-1:2017(E)
Key
1 needle cap or shield (if used) 10 plunger cap
2 nozzle cap 11 barrel flanges (finger grips)
3 nozzle lumen 12 fiducial line
4 nozzle 13 nominal capacity
5 barrel 14 graduation lines
6 plunger stopper (3-piece only) 15 zero line
7 seals 16 needle tube
8 plunger 17 hub
9 push-button
NOTE The figure is intended to be illustrative of the components of a syringe. The plunger stopper/plunger
assembly can or cannot be of integral construction and can or cannot incorporate more than one seal.
Figure 1 — Schematic representation of hypodermic syringe for single use
4 © ISO 2017 – All rights reserved

ISO 7886-1:2017(E)
5 General requirements
The general requirements are considered to be design inputs for manufacturers.
a) Syringes shall be free from defects affecting appearance, safety and performance for their intended
use. Syringes with integrated or add-on sharps protection shall comply with ISO 23908.
— The syringe’s barrel flanges shall be of adequate size, shape and strength for the intended
purpose. The design specifications for the barrel flanges shall be determined through risk
analysis and confirmed through usability validation testing.
— The materials shall not cause the syringes to yield, under conditions of normal use, significant
amounts of toxic substances and shall permit them to satisfy the appropriate national
requirements or regulations for freedom from pyrogenic materials and abnormal toxicity.
— Materials used in the construction of the wall of the syringe barrel shall have sufficient clarity
to enable dosages to be read without difficulty.
— The standard does not specify materials to be used for the construction and lubrication of
sterile syringes with or without needles for single use, because their selection will depend,
to some extent, upon the manufacturers specific syringe design, process of manufacture and
sterilization method.
b) The design and validation of the packaging shall take into consideration the final use of the syringe
and the storage and shipping conditions and the defined shelf life.
6 Extraneous matter
6.1 General
The surfaces of the syringe that come in contact with injection fluids during normal use shall be free
from particles and extraneous matter.
NOTE Compliance with this requirement will be determined through inspection by an individual with
normal vision (or corrected-to-normal vision), without magnification.
6.2 Limits for acidity or alkalinity
Exposure of distilled water to the finished syringe product shall not change its pH value by more than
one unit.
Compliance with this requirement shall be demonstrated by preparing the solutions described in
Annex A. The results shall show that the pH value of the syringe assessment fluid is within one pH unit
of the pH value of the control fluid.
The pH value of both solutions may be determined with a laboratory potentiometric pH meter using a
general purpose electrode.
6.3 Limits for extractable metals
Exposure of distilled water to the finished syringe product shall not change its content of metals by
more than a combined total of 5 mg/kg of lead, tin, zinc and iron; the cadmium content shall be less
than 0,1 mg/kg.
Compliance with this requirement shall be demonstrated by preparing the solutions described in
Annex A and testing them using a recognized micro-analytical method, for example, by an atomic
absorption method or by an inductively coupled plasma mass spectrometry method (ICP).
ISO 7886-1:2017(E)
7 Lubricant
When the plunger stopper is fully inserted the amount of lubricant applied into the barrel shall not
reach the Luer channel of the nozzle.
For lubricants applied to interior surface of the syringe, the quantity of lubricant applied shall not
exceed 0,25 mg/cm of the interior surface area of the syringe in contact with the injection fluid.
The amount and distribution of lubricant applied should be optimized to minimize lubricant visibility.
NOTE 1 An acceptable lubricant is silicone complying with a national or the European pharmacopoeia and
ISO 10993-1.
For lubricants incorporated in the polymer formulation, the quantity of lubricant shall not exceed 0,6 %
(w/w) of the mass of the component, but attention is drawn to the fact that some national regulations
may specify a lower maximum concentration.
NOTE 2 If a lubricant is incorporated in the polymer formulation, visible particles can become apparent when
the lubricant blooms to the surface of the syringe barrel and the plunger stopper scrapes it off.
NOTE 3 Example of acceptable lubricants incorporated in the polymer formulation are fatty acid amides of
erucic and/or oleic acids complying with ISO 10993-1.
NOTE 4 See Annex F for a test method for the quantity of silicone oil.
8 Tolerance on graduated capacity
The tolerances on the graduated capacity shall be as given in Table 1.
Table 1 — Capacity tolerance, dead space, scale dimensions and test forces
Mini- Forces for leak-
Tolerance on any
mum Increment age testing
graduated capacity
Nominal Maxi- overall between (see Annex D)
Scale
capacity mum length of gradua-
inter- Axial
Side
of syringe dead scale to tion lines
Equal to or val pressure
force
space nominal to be
Less than half greater than (gauge)
V
capacity ml numbered
nominal capacity half nominal (±5 %)
ml ml
(±5 %)
mark
capacity
ml
N
kPa
mm
±(1,5 % of V + 2 % ±5 % of
V < 2 of expelled vol- expelled vol- 0,07 57 0,05 0,1 0,25 300
ume) ume
±(1,5 % of V + 2 % ±5 % of
2 ≤ V < 5 of expelled vol- expelled vol- 0,07 27 0,2 1 1,0 300
ume) ume
±(1,5 % of V + 1 % ±4 % of
5 ≤ V < 10 of expelled vol- expelled vol- 0,075 36 0,5 1 2,0 300
ume) ume
±(1,5 % of V + 1 % ±4 % of
10 ≤ V < 20 of expelled vol- expelled vol- 0,10 44 1,0 5 2,0 300
ume) ume
NOTE  Expelled volume means all the liquid ejected with the seal brought to the physical limit that was designed to be
coincident with the zero mark of the scale.
EXAMPLE 1  For a 3 ml syringe, when filled to the 1 ml graduation (less than 1/2 capacity), the required tolerance would
be ±(1,5 % × 3 ml + 2 % × 1 ml) = 0,065 ml
EXAMPLE 2  For a 3 ml syringe, when filled to the 2 ml graduation (greater than 1/2 capacity), the required tolerance
would be ±(5 % × 2 ml) = 0,100 ml.
6 © ISO 2017 – All rights reserved

ISO 7886-1:2017(E)
Table 1 (continued)
Mini- Forces for leak-
Tolerance on any
mum Increment age testing
graduated capacity
Nominal Maxi- overall between (see Annex D)
Scale
capacity mum length of gradua-
Axial
inter-
Side
of syringe dead scale to tion lines
Equal to or pressure
val
force
space nominal to be
Less than half greater than (gauge)
V
capacity ml numbered
nominal capacity half nominal (±5 %)
ml ml
(±5 %)
mark
capacity
ml
N
kPa
mm
±(1,5 % of V + 1 % ±4 % of
20 ≤ V < 30 of expelled vol- expelled vol- 0,15 52 2,0 10 3,0 200
ume) ume
±(1,5 % of V + 1 % ±4 % of
30 ≤ V < 50 of expelled vol- expelled vol- 0,17 67 2,0 10 3,0 200
ume) ume
±(1,5 % of V + 1 % ±4 % of
V ≥ 50 of expelled vol- expelled vol- 0,20 75 5,0 10 3,0 200
ume) ume
NOTE  Expelled volume means all the liquid ejected with the seal brought to the physical limit that was designed to be
coincident with the zero mark of the scale.
EXAMPLE 1  For a 3 ml syringe, when filled to the 1 ml graduation (less than 1/2 capacity), the required tolerance would
be ±(1,5 % × 3 ml + 2 % × 1 ml) = 0,065 ml
EXAMPLE 2  For a 3 ml syringe, when filled to the 2 ml graduation (greater than 1/2 capacity), the required tolerance
would be ±(5 % × 2 ml) = 0,100 ml.
9 Graduated scale
9.1 Scale
9.1.1 The syringe shall have either only one scale or more than one identical scales, which shall be
graduated and numbered at least at the intervals given in Table 1. The unit of volume shall be marked on
the barrel.
NOTE The scale interval can be less (finer) than the scale interval given in Table 1.
If necessary by a specific application, the scale may vary and this requirement does not preclude the
provision of additional graduation marks within the scale or as extensions to the scale. Any variation of
the scale or graduation is recommended to be assessed for risk according to ISO 14971 and for usability
according to IEC 62366.
9.1.2 The total graduated capacity may be equal to, or greater than, the nominal capacity. If the scale
is extended beyond the nominal capacity, the extended portion shall be differentiated from the rest of
the scale.
Examples of means of differentiation are the following:
a) encircling the scale number of the nominal capacity line;
b) using smaller scale numbers for the extra graduation lines;
c) using shorter graduation lines for the extra graduation lines;
d) using a broken line for the optional vertical line of the extra scale length.
9.1.3 Graduation lines shall be of uniform thickness. They shall lie in planes at right angles to the axis
of the barrel.
...