SIST EN ISO 7886-2:2020
(Main)Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:2020)
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:2020)
EN-ISO 7886-2 specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps. This document does not apply to syringes with auto-disable syringe features (ISO 7886-3[2]), syringes for use with insulin (ISO 8537[3]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.
Sterile Einmalspritzen für medizinische Zwecke - Teil 2: Spritzen zur Verwendung mit Spritzenpumpen (ISO 7886-2:2020)
Dieses Dokument legt die Anforderungen für sterile Einmalspritzen mit einem Nennvolumen von 1 ml und größer fest, die aus Kunststoffen hergestellt und zur Verwendung mit Druckinfusionsapparaten vorgesehen sind.
Dieses Dokument gilt nicht für selbstblockierende Spritzen (ISO 7886 3 [2]), Insulinspritzen (ISO 8537 [3]), Einmalspritzen aus Glas, vom Hersteller mit injizierbarer Zubereitung vorgefüllte Spritzen sowie zusammen mit der injizierbaren Zubereitung gelieferte Beilagespritzen, die vom Apotheker gefüllt werden. Es behandelt nicht die Kompatibilität mit Injektionsflüssigkeiten.
Seringues hypodermiques stériles, non réutilisables - Partie 2: Seringues pour pousse-seringues mus par un moteur (ISO 7886-2:2020)
Le présent document spécifie les exigences relatives aux seringues hypodermiques stériles non réutilisables, ayant une capacité nominale égale ou supérieure à 1 ml, fabriquées en matières plastiques et destinées à être utilisées avec des pousse-seringues électriques.
Le présent document ne s'applique pas aux seringues dotées d'un système autobloquant (ISO 7886‑3[2]), aux seringues à insuline (ISO 8537[3]), aux seringues en verre non réutilisables, aux seringues préremplies avec le produit d'injection par le fabricant et aux seringues fournies avec le produit d'injection sous forme de kit par un pharmacien. Il ne traite pas de la compatibilité avec les liquides d'injection.
Sterilne podkožne injekcijske brizge za enkratno uporabo - 2. del: Injekcijske brizge za injiciranje z injekcijskimi črpalkami (ISO 7886-2:2020)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 7886-2:2020
01-julij-2020
Nadomešča:
SIST EN ISO 7886-2:2000
Sterilne podkožne injekcijske brizge za enkratno uporabo - 2. del: Injekcijske
brizge za injiciranje z injekcijskimi črpalkami (ISO 7886-2:2020)
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven
syringe pumps (ISO 7886-2:2020)
Sterile Einmalspritzen für medizinische Zwecke - Teil 2: Spritzen zur Verwendung mit
Spritzenpumpen (ISO 7886-2:2020)
Seringues hypodermiques stériles, non réutilisables - Partie 2: Seringues pour pousse-
seringues mus par un moteur (ISO 7886-2:2020)
Ta slovenski standard je istoveten z: EN ISO 7886-2:2020
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 7886-2:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 7886-2:2020
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SIST EN ISO 7886-2:2020
EN ISO 7886-2
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2020
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 7886-2:1997
English Version
Sterile hypodermic syringes for single use - Part 2:
Syringes for use with power-driven syringe pumps (ISO
7886-2:2020)
Seringues hypodermiques stériles, non réutilisables - Sterile Einmalspritzen für medizinische Zwecke - Teil
Partie 2: Seringues pour pousse-seringues électriques 2: Spritzen zur Verwendung mit Spritzenpumpen (ISO
(ISO 7886-2:2020) 7886-2:2020)
This European Standard was approved by CEN on 27 April 2020.
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 NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7886-2:2020 E
worldwide for CEN national Members.
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SIST EN ISO 7886-2:2020
EN ISO 7886-2:2020 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 7886-2:2020
EN ISO 7886-2:2020 (E)
European foreword
This document (EN ISO 7886-2:2020) 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 November 2020, and conflicting national standards
shall be withdrawn at the latest by November 2020.
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 7886-2:1997.
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, 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 the
United Kingdom.
Endorsement notice
The text of ISO 7886-2:2020 has been approved by CEN as EN ISO 7886-2:2020 without any
modification.
3
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SIST EN ISO 7886-2:2020
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SIST EN ISO 7886-2:2020
INTERNATIONAL ISO
STANDARD 7886-2
Second edition
2020-04
Sterile hypodermic syringes for
single use —
Part 2:
Syringes for use with power-driven
syringe pumps
Seringues hypodermiques stériles, non réutilisables —
Partie 2: Seringues pour pousse-seringues électriques
Reference number
ISO 7886-2:2020(E)
©
ISO 2020
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SIST EN ISO 7886-2:2020
ISO 7886-2:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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 2020 – All rights reserved
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SIST EN ISO 7886-2:2020
ISO 7886-2:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Nomenclature . 1
5 General requirements . 2
6 Limits for acidity or alkalinity. 2
7 Limits for extractable metals . 2
8 Lubricant . 2
9 Tolerance on graduated capacity . 2
10 Graduated scale . 2
11 Syringe design . 2
12 Piston/plunger assembly . 4
12.1 Design . 4
12.2 Fit of plunger stopper/plunger in barrel . 4
13 Nozzle . 4
13.1 Conical fitting . 4
13.2 Nozzle lumen . 4
14 Performance . 4
14.1 Dead space . 4
14.2 Freedom from air and liquid leakage past the plunger stopper . 4
14.3 Short-term flow rate error . 4
14.4 Pump forces . 5
14.5 Syringe compliance . 5
15 Packaging . 6
15.1 Unit packaging and self-contained syringe units . 6
15.1.1 Unit packaging . 6
15.1.2 Self-contained syringe units . 6
15.2 Multiple unit pack. 6
15.3 User packaging . 6
16 Information supplied by the manufacturer . 6
16.1 General . 6
16.2 Syringes . 6
16.2.1 General. 6
16.2.2 Additional marking for self-contained syringe units. 7
16.3 Unit packaging . 7
16.4 Multiple unit packs . 7
16.4.1 General. 7
16.4.2 Multiple unit packs with self-contained syringes. 7
16.5 User packaging . 7
16.6 Storage container . 7
16.7 Transport wrapping . 7
Annex A (normative) Short-term flow rate accuracy . 8
Annex B (informative) Pump force .13
Annex C (normative) Determination of syringe compliance .15
© ISO 2020 – All rights reserved iii
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SIST EN ISO 7886-2:2020
ISO 7886-2:2020(E)
Bibliography .17
iv © ISO 2020 – All rights reserved
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SIST EN ISO 7886-2:2020
ISO 7886-2:2020(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 of 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 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 7886-2:1996), which has been technically
revised. The main changes compared to the previous edition are as follows:
— Syringe sizes 1 ml to 5 ml were added to the scope of this document.
— Overall flow rate requirement was removed from Clause 14 as it is predominantly affected by the
barrel inner diameter (ID), which is addressed in Clause 11.
— Pump test speeds were adjusted for each syringe size to better reflect the range of speeds used in
general clinical settings.
A list of all parts in the ISO 7886 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2020 – All rights reserved v
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SIST EN ISO 7886-2:2020
ISO 7886-2:2020(E)
Introduction
0.1 General
In the preparation of this document, it was recognized at an early stage that the absolute criterion
of performance is achieved by the combination of the power-driven syringe pump and the syringe
working as a complete system. The dependence of one element of the system on the performance of
the other is a key factor. It is essential for the manufacturer of one of these components to liaise with
the manufacturer of the other when considering changes in design, in order to ensure satisfactory
operation of the system. In particular, a syringe manufacturer should give information on tolerances
and relationships between the syringe dimensions specified in this document and on performance
characteristics such as the force to move the plunger, and the variation which might be expected.
The selection of test speeds for flow rate accuracy recognized that low speeds are worse-case and
result in large variation; however, selecting speeds of less than 1 ml/h was considered inappropriate
due to limitations of the gravimetric test method error (due to factors such as balance stabilization and
difficulty in measuring micro amounts of fluid using balances designed for static measurements).
It is recognized that start-up time and travel through parking position may impact pump forces and
should be considered for exclusion, if necessary.
The syringe driver and measurement equipment characteristics might influence test method error;
therefore, it is recommended to include the appropriate level of accuracy and precision of equipment
and to perform test method validations.
0.2 Design criteria
The use of syringes which were initially designed and used as manually-operated devices in syringe
pumps now makes it desirable to achieve much tighter tolerances on syringe dimensions than normally
required for manual use.
It is understood that the degree of investment worldwide by all syringe manufacturers in molding and
manufacturing equipment is such that a change such as modifying diameters of push-buttons or the
barrel inner diameter (ID) is largely out of reach of the syringe industry.
Typically, the hard height of a syringe has never been regarded as a particularly critical dimension. Its
tolerances are relatively loose. The hard-height dimension is a function of not only the total length of
plunger rod and the barrel, but also the thickness of the piston and barrel flanges. The piston thickness,
by virtue of its relatively unsophisticated manufacturing process, can vary considerably. Because all
these components are manufactured in multi-cavity molds from many molds around the world, the
cumulative extreme tolerance buildup from cavity to cavity and mold to mold and location to location is
such that these previously noncritical dimensions cannot be instantly tightened.
0.3 Syringe identification
It is important that when a syringe is fitted to a syringe pump, the pump is correctly programmed to
perform satisfactorily with the particular syringe installed.
In view of the consequences of incorrect syringe identification by the pump, the need for an automatic
system is recognized. Methods already in use, such as mechanical sensing of the syringe outer diameter,
are not deemed feasible in the long term to reduce errors in syringe identification. This is due to
overlapping ranges of diameter of syringes produced by different manufacturers. It is also recognized
that standardization of syringe barrel diameters (IDs) across the industry is not a realistic option.
A means by which the pump could automatically identify the syringe model and use this to program
such information as barrel inner diameter (ID), plunger force and occlusion alarm settings is seen as
the next stage of this standard. A possible method of recognition is to identify the syringe and nominal
capacity by means of a marking code on the barrel, printed at the same time as the syringe scale, and to
use this to program the pump automatically. It is recommended that development of such a system be
worked on as soon as possible.
vi © ISO 2020 – All rights reserved
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SIST EN ISO 7886-2:2020
ISO 7886-2:2020(E)
0.4 Infusion speeds and syringe size selection
The flow rates described in this document are for syringe tests and are not recommendations for
clinical practice.
In general, as flow rate accuracy is dependent on linear travel of the plunger/pump driver, smaller size
syringes tend to have a higher resolution and they also tend to have a higher flow rate accuracy at
slower speeds.
Guidance on transition periods for implementing the requirements of this document is given in
[1]
ISO/TR 19244 .
© ISO 2020 – All rights reserved vii
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SIST EN ISO 7886-2:2020
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SIST EN ISO 7886-2:2020
INTERNATIONAL STANDARD ISO 7886-2:2020(E)
Sterile hypodermic syringes for single use —
Part 2:
Syringes for use with power-driven syringe pumps
1 Scope
This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity
1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps.
[2]
This document does not apply to syringes with auto-disable syringe features (ISO 7886-3 ), syringes
[3]
for use with insulin (ISO 8537 ), single-use syringes made of glass, syringes prefilled with the injection
by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does
not address compatibility with injection fluids.
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 3696, Water for analytical laboratory use — Specification and test methods
ISO 7886-1:2017, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated
terms (VIM)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 7886-1, ISO/IEC Guide 99 and
the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
parking position
location in the barrel where the plunger stopper is positioned before the user opens the packaging
4 Nomenclature
The requirements specified in ISO 7886-1:2017, Clause 4 apply.
© ISO 2020 – All rights reserved 1
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SIST EN ISO 7886-2:2020
ISO 7886-2:2020(E)
5 General requirements
The requirements specified in ISO 7886-1:2017, Clause 5 apply.
6 Limits for acidity or alkalinity
The requirements specified in ISO 7886-1:2017, 6.2 apply.
7 Limits for extractable metals
The requirements specified in ISO 7886-1:2017, 6.3 apply.
8 Lubricant
The requirements specified in ISO 7886-1:2017, Clause 7 apply.
9 Tolerance on graduated capacity
The requirements specified in ISO 7886-1:2017, Clause 8 apply.
10 Graduated scale
The requirements specified in ISO 7886-1:2017, Clause 9 apply.
11 Syringe design
Critical dimensions for the fit of the syringe in a syringe pump shall be designated as shown in Figure 1
and shall be as given in Table 1.
Table 1 — Syringe dimensions critical to volume and flow accuracy
Nominal Syringe dimensions
capacity, V
Tolerance on B C D E F
ØA min. max. min. min. max.
ml
±% mm mm mm mm mm
1 ≤ V < 2 2 4 3 10 2 3
2 ≤ V < 5 1 4 3 10 2 3
5 ≤ V < 10 1 4 3 10 2 3
10 ≤ V < 20 1 4 3 10 2 3
20 ≤ V < 30 1 4 3 10 2 4
30 ≤ V < 50 0,5 4 3,5 10 2 4
V ≥50 0,5 4 3,5 10 2 4
2 © ISO 2020 – All rights reserved
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SIST EN ISO 7886-2:2020
ISO 7886-2:2020(E)
Dimensions in millimetres
a) Side view
b) Top view
Key
A mean inner diameter of the barrel over the swept volume
B distance of the projection of the barrel flanges from the outside surface of the barrel
C thickness of the barrel flanges
D distance from the surface of the barrel flanges nearer to the push-button to the surface of the push-button
further from the barrel flanges when the fiducial line of the piston coincides with the zero line of the scale
E projection of the push-button beyond the outer dimension of the plunger ribs
F overall thickness of the push-button (including ribs, etc., if present)
G outside diameter of the barrel measured at a distance of 10 mm from the underside of the barrel flanges
H hard height (C + D)
J diameter of push-button
K luer lock fitting
Figure 1 — Designation of dimensions
© ISO 2020 – All rights reserved 3
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SIST EN ISO 7886-2:2020
ISO 7886-2:2020(E)
All other dimensional and design requirements shall be as specified in ISO 7886-1.
The design of the push-button should be such that it does not inhibit the fit in a syringe pump driver
mechanism designed to accept a flat push-button and it does not inhibit the detection by a built-in
detection device. The barrel flanges [see Figure 1 a)] should not be tapered.
The fit of the plunger stopper on the plunger should be such that relative axial movement between the
two is kept to a minimum in order to reduce the possibility of free flow or siphoning.
12 Piston/plunger assembly
12.1 Design
The requirements specified in ISO 7886-1:2017, 11.1 apply.
12.2 Fit of plunger stopper/plunger in barrel
The requirements specified in ISO 7886-1:2017, 13.4 apply.
13 Nozzle
13.1 Conical fitting
The male conical fitting of the syringe nozzle shall be in accordance with ISO 80369-7 and shall have a
locking fitting in accordance with ISO 80369-7.
13.2 Nozzle lumen
The requirements specified in ISO 7886-1:2017, 12.3 apply.
14 Performance
14.1 Dead space
The requirements specified in ISO 7886-1:2017, 13.1 apply.
14.2 Freedom from air and liquid leakage past the plunger stopper
The requirements specified in ISO 7886-1:2017, 13.2 apply.
14.3 Short-term flow rate error
When tested as described in Annex A, the flow rates, start-up time (exclusion time) and analysis period
shall be as shown in Table 2.
Table 2 — Flow rates specifications
Nominal capacity of syringe, V Start-up time
Flow rates Analysis period
min
ml/h min
ml
50
1 ≤ V < 2 1 10
minus parking position
60
2 ≤ V < 10 1 30
minus parking position
4 © ISO 2020 – All rights reserved
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...
SLOVENSKI STANDARD
oSIST prEN ISO 7886-2:2019
01-julij-2019
Sterilne podkožne injekcijske brizge za enkratno uporabo - 2. del: Injekcijske
brizge za injiciranje z injekcijskimi črpalkami (ISO/DIS 7886-2:2019)
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven
syringe pumps (ISO/DIS 7886-2:2019)
Sterile Einmalspritzen für medizinische Zwecke - Teil 2: Spritzen zur Verwendung mit
Spritzenpumpen (ISO/DIS 7886-2:2019)
Seringues hypodermiques stériles, non réutilisables - Partie 2: Seringues pour pousse-
seringues mus par un moteur (ISO/DIS 7886-2:2019)
Ta slovenski standard je istoveten z: prEN ISO 7886-2
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 7886-2:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 7886-2:2019
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oSIST prEN ISO 7886-2:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 7886-2
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2019-05-17 2019-08-09
Sterile hypodermic syringes for single use —
Part 2:
Syringes for use with power-driven syringe pumps
Seringues hypodermiques stériles, non réutilisables —
Partie 2: Seringues pour pousse-seringues mus par un moteur
ICS: 11.040.25
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
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 7886-2:2019(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 2019
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oSIST prEN ISO 7886-2:2019
ISO/DIS 7886-2:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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 2019 – All rights reserved
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oSIST prEN ISO 7886-2:2019
ISO/DIS 7886-2:2019(E)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Nomenclature . 1
5 Cleanliness . 1
6 Limits for acidity or alkalinity. 2
7 Limits for extractable metals . 2
8 Lubricant . 2
9 Tolerance on graduated capacity . 2
10 Graduated scale . 2
11 Syringe design . 2
12 Piston/plunger assembly . 4
12.1 Design . 4
12.2 Fit of plunger stopper/plunger in barrel . 4
13 Nozzle . 4
13.1 Conical fitting . 4
13.2 Nozzle lumen . 4
14 Performance . 4
14.1 Dead space . 4
14.2 Freedom from air and liquid leakage past the plunger stopper . 4
14.3 Short-term flow rate error . 4
14.4 Pump forces . 5
14.5 Syringe compliance . 5
15 Packaging . 6
15.1 Unit Packaging and self-contained syringe units . 6
15.1.1 Unit Packaging . 6
15.1.2 Self-contained syringe units . 6
15.2 Multiple unit pack. 6
15.3 User packaging . 6
16 Information supplied by the manufacturer [Labelling] . 6
16.1 General . 6
16.2 Syringes . 6
16.2.1 General. 6
16.2.2 Additional marking for self-contained syringe units. 6
16.3 Unit packaging . 6
16.4 Multiple unit packs . 7
16.4.1 General. 7
16.4.2 Multiple unit packs with self-contained syringes. 7
16.5 User packaging . 7
16.6 Storage container . 7
16.7 Transport wrapping . 7
16.8 Unit packaging . 7
16.9 Storage container . 7
16.10 Transport wrapping . 8
Annex A (normative) Short-term flow rate accuracy . 9
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oSIST prEN ISO 7886-2:2019
ISO/DIS 7886-2:2019(E)
Annex B (informative) Pump force .14
Annex C (normative) Determination of syringe compliance .16
Bibliography .18
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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 7886-2:1996), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— General:
In the preparation of this document, it was recognized at an early stage that the absolute criterion
of performance is achieved by the combination of the power-driven syringe pump and the syringe
working as a complete system. The dependence of one element of the system on the performance of
the other is a key factor. It is essential for the manufacturer of one of these components to liaise with
the manufacturer of the other when considering changes in design, in order to ensure satisfactory
operation of the system. In particular, a syringe manufacturer should give information on tolerances
and relationships between the syringe dimensions specified in this document and on performance
characteristics such as the force to move the plunger, and the variation which might be expected.
Syringe sizes 1 ml to 5 ml were added to the scope of this document.
Overall flow rate requirement was removed from Clause 14 as it is predominantly affected by the barrel
ID, which is addressed in Clause 12.
The selection of test speeds for flow rate accuracy recognized that low speeds are worse-case and
result in large variation; however, selecting speeds of less than 1 ml/h was considered inappropriate
due to limitations of the gravimetric test method error [due to factors such as balance stabilization and
difficulty in measuring micro amounts of fluid using balances designed for static measurements].
Pump test speeds were adjusted for each syringe size to better reflect the range of speeds used in
general clinical settings. It is recognized that start-up time and travel through parking position may
impact pump forces and should be considered for exclusion, if necessary.
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ISO/DIS 7886-2:2019(E)
The syringe driver and measurement equipment characteristics may influence test method error;
therefore, it is recommended to include the appropriate level of accuracy and precision of equipment
and to perform test method validations.
— Design criteria:
The use of syringes which were initially designed and used as manually-operated devices in syringe
pumps now makes it desirable to achieve much tighter tolerances on syringe dimensions than normally
required for manual use.
It is understood that the degree of investment worldwide by all syringe manufacturers in molding and
manufacturing equipment is such that a change such as modifying diameters of push-buttons or the
barrel inner diameter is largely out of reach of the syringe industry.
Typically, the hard height of a syringe has never been regarded as a particularly critical dimension. Its
tolerances are relatively loose. The hard-height dimension is a function of not only the total length of
plunger rod and the barrel, but also the thickness of the piston and barrel flanges. The piston thickness,
by virtue of its relatively unsophisticated manufacturing process, can vary considerably. Because all
these components are manufactured in multi-cavity molds from many molds around the world, the
cumulative extreme tolerance buildup from cavity to cavity and mold to mold and location to location is
such that these previously noncritical dimensions cannot be instantly tightened.
— Syringe identification:
It is important that when a syringe is fitted to a syringe pump, the pump is correctly programmed to
perform satisfactorily with the particular syringe installed.
In view of the consequences of incorrect syringe identification by the pump, the need for an automatic
system is recognized. Methods already in use, such as mechanical sensing of the syringe outer diameter,
are not deemed feasible in the long term to reduce errors in syringe identification. This is due to
overlapping ranges of diameter of syringes produced by different manufacturers. It is also recognized
that standardization of syringe barrel diameters across the industry is not a realistic option.
A means by which the pump could automatically identify the syringe model and use this to program
such information as barrel inner diameter, plunger force and occlusion alarm settings is seen as the
next stage of this standard. A possible method of recognition is to identify the syringe and nominal
capacity by means of a marking code on the barrel, printed at the same time as the syringe scale, and to
use this to program the pump automatically. It is recommended that development of such a system be
worked on as soon as possible.
— Infusion speeds and syringe size selection:
The flow rates described in this document are for syringe tests and are not recommendations for
clinical practice.
In general, as flow rate accuracy is dependent on linear travel of the plunger/pump driver, smaller size
syringes tend to have a higher resolution also tend to have higher flow rate accuracy at slower speeds.
A list of all parts in the ISO 7886- series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
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Introduction
Guidance on transition periods for implementing the requirements of this document is given in ISO/
[1]
TR 19244.
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DRAFT INTERNATIONAL STANDARD ISO/DIS 7886-2:2019(E)
Sterile hypodermic syringes for single use —
Part 2:
Syringes for use with power-driven syringe pumps
1 Scope
This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity
1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps.
[2]
This document does not apply to syringes for use with insulin (specified in ISO 8537 ), single-use
syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied
with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.
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 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 7886-1:2017, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications — Part 7:
Connectors for intravascular or hypodermic applications
IEC 60601-2-24:2012, Medical electrical equipment — Part 2: Particular requirements for safety of infusion
pumps and controllers
3 Terms and definitions
[3]
For the purposes of this document, the terms and definitions given in ISO 7886-1 and VIM 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
parking position
location in the barrel where the plunger stopper is positioned before the user opens the packaging
4 Nomenclature
ISO 7886-1:2017, Clause 4 apply.
5 Cleanliness
ISO 7886-1:2017, Clause 5 apply.
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6 Limits for acidity or alkalinity
ISO 7886-1:2017, 6.2 apply.
7 Limits for extractable metals
ISO 7886-1:2017, 6.3 apply.
8 Lubricant
ISO 7886-1:2017, Clause 7 apply.
9 Tolerance on graduated capacity
ISO 7886-1:2017, Clause 8 apply.
10 Graduated scale
ISO 7886-1:2017, Clause 9 apply.
11 Syringe design
Critical dimensions for the fit of the syringe in a syringe pump shall be designated as shown in Figure 1
and shall be as given in Table 1.
Table 1 — Syringe dimensions critical to volume and flow accuracy
Nominal Syringe dimensions
capacity
[ml]
Tolerance on B C D E F
Ø A min. max. min. min. max.
[±%] [mm] [mm] [mm] [mm] [mm]
≥ 1 and < 2 2 4 3 10 2 3
≥ 2 and < 5 1 4 3 10 2 3
≥ 5 and < 10 1 4 3 10 2 3
≥ 10 and < 20 1 4 3 10 2 3
≥ 20 and < 30 1 4 3 10 2 4
≥ 30 and < 50 0,5 4 3,5 10 2 4
≥ 50 0,5 4 3,5 10 2 4
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a)
b)
Key
A mean inner diameter of the barrel over the swept volume.
B distance of the projection of the barrel flanges from the outside surface of the barrel.
C thickness of the barrel flanges.
D distance from the surface of the barrel flanges nearer to the push-button to the surface of the push-button
further from the barrel flanges when the fiducial line of the piston coincides with the zero line of the scale.
E projection of the push-button beyond the outer dimension of the plunger ribs.
F overall thickness of the push-button (including ribs, etc., if present).
G outside diameter of the barrel measured at a distance of 10 mm from the underside of the barrel flanges.
H hard height (C + D).
J diameter of push-button
K luer lock fitting
NOTE 1 The barrel flanges should not be tapered (see C).
NOTE 2 b) is top view.
Figure 1 — a) and b) — Designation of dimensions
All other dimensional and design requirements shall be as specified in ISO 7886-1.
The push-button should be of such a design as to neither inhibit the fit in a syringe pump driver
mechanism designed to accept a flat push-button nor the detection by a built-in detection device.
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oSIST prEN ISO 7886-2:2019
ISO/DIS 7886-2:2019(E)
The fit of the plunger stopper on the plunger should be such that relative axial movement between the
two is kept to a minimum in order to reduce the possibility of free flow or siphoning.
12 Piston/plunger assembly
12.1 Design
ISO 7886-1:2017, 11.1 apply.
12.2 Fit of plunger stopper/plunger in barrel
ISO 7886-1:2017, 13.4 apply.
13 Nozzle
13.1 Conical fitting
The male conical fitting of the syringe nozzle shall be in accordance with ISO 80369-7 and shall have a
locking fitting in accordance with ISO 80369-7.
13.2 Nozzle lumen
ISO 7886-1:2017, 12.3 apply.
14 Performance
14.1 Dead space
ISO 7886-1:2017, 13.1 apply.
14.2 Freedom from air and liquid leakage past the plunger stopper
ISO 7886-1:2017, 13.2 apply.
14.3 Short-term flow rate error
When tested as described in Annex A, the flow rates, start-up time [exclusion time] and analysis period
are listed in Table 2.
Table 2 — Flow rates specifications
Flow rates Start-up time Analysis period
Syringe size [V]
[ml/h] [minute] [min]
50
1 ml ≤ V < 2 ml 1 10
minus parking position
60
2 ml ≤ V < 10 ml 1 30
minus parking position
60
10 ml ≤ V 5 30
minus parking position
The maximum permissible error in flow rate when measured in two observation-time windows shall
be as shown in Table 3.
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Table 3 — Maximum permissible flow rate error
Observation window Maximum error in flow rate
Syringe size [V]
[minute] [%]
2 All syringe sizes ± 5
1 ml ≤ V < 10 ml ± 5
5
10 ml ≤ V ± 4
NOTE The allowed error on expelled volume from the syringe as defined in ISO 7886-1 [table 1 tolerance on graduated
volume capacity] was used as a basis for calculation of the allowed flow rate error for the 5-minute window.
14.4 Pump forces
Syringe manufacturers should perform pump force characterization and make available to pump
manufacturers for syringes which are indicated for use on pumps. Flow rates used for pump forces are
listed in Table 4 and details for the method used to test each syringe size are in Annex B.
Pump manufacturers should also perform the testing described in Annex B to ensure correct software
programming. This data should be shared between pump and syringe manufacturers to ensure correct
regional product has been characterized for a given market.
Table 4 — Recommended flow rates for pump forces
Syringe size
Flow rates
[ml/h]
[ml]
Low Medium High
≥ 1 and < 2 0.5 2 5
≥ 2 and < 5 1 5 10
≥ 5 and < 10 5 10 25
≥ 10 and < 20 5 10 50
≥ 20 and < 30 0.5 25 50
≥ 30 and < 50 0.5 25 50
≥ 50 1 50 100
NOTE The flow rates are for syringe tests and not recommendations for clinical practice.
14.5 Syringe compliance
When tested as described in Annex C, the maximum displacement of fluid shall be within given values
shown in Table 5.
Table 5 — Maximum allowable fluid displaced as a function of pressure
Test pressure [kPa]
Syringe nominal capacity
[ml]
≥ 7 ≥ 40 ≥ 70 ≥ 90 ≥ 133
Maximum displacement volume [ml]
≥ 1 and < 2 n/a n/a n/a 0,03 0,04
≥ 2 and < 5 n/a 0,05 0,08 0,11 0,13
≥ 5 and < 10 0,03 0,10 0,15 0,20 0,25
≥ 10 and < 20 0,10 0,20 0,30 0,35 0,40
≥ 20 and < 30 0,10 0,40 0,60 0,80 0,90
≥30 and < 50 0,10 0,40 0,60 0,80 0,90
≥ 50 0,40 1,20 1,50 1,80 2,10
1kPa = 7,5 mmHg (approx.) = 0,145 Ibf/in* (p.s.i.) (approx.).
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15 Packaging
15.1 Unit Packaging and self-contained syringe units
15.1.1 Unit Packaging
ISO 7886-1:2017, 14.1.1 apply.
15.1.2 Self-contained syringe units
ISO 7886-1:2017, 14.1.2 apply.
15.2 Multiple unit pack
ISO 7886-1:2017, 14.2 apply.
15.3 User packaging
ISO 7886-1:2017, 14.3 apply.
16 Information supplied by the manufacturer [Labelling]
16.1 General
ISO 7886-1:2017, 15.1 apply.
16.2 Syringes
16.2.1 General
ISO 7886-1:2017, 15.2.1 apply.
In addition to ISO 7886-1:
a) The syringe barrel shall be marked with the manufacturer's name or logo;
b) The model identification, if a manufacturer offers more than one product of the same nominal
cap
...
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