SIST EN ISO 7886-3:2020
(Main)Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization (ISO 7886-3:2020)
Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization (ISO 7886-3:2020)
EN-ISO 7886-3 specifies the properties and performance of sterile single-use hypodermic syringes with an auto-disable syringe feature intended to deliver a fixed dose of vaccine immediately after filling. The syringes can be made of plastic, rubber or other materials and can be with or without needle and needle protection feature.This document does not specify the design of the auto-disable syringe feature.This document is not applicable to syringes for use with insulin (covered by ISO 8537), syringes for use with power-driven syringe pumps (covered by ISO 7886-2), reuse prevention syringes (covered by ISO 7886-4) or syringes designed to be prefilled (covered by the ISO 11040 series). It does not address compatibility with injection fluids/vaccines.
Sterile Einmalspritzen für medizinische Zwecke - Teil 3: Selbstblockierende Spritzen für die Injektion mit fixer Impfstoffdosis (ISO 7886-3:2020)
Dieses Dokument legt Eigenschaften und Leistungsmerkmale für sterile Einmalspritzen mit einem Selbstblockierungsbauteil fest, die für die Abgabe einer fixen Impfdosis unmittelbar nach ihrem Befüllen vorgesehen sind. Die Spritzen können aus Kunststoff, Gummi oder anderen Werkstoffen gefertigt, und mit oder ohne Kanüle und Kanülenschutzvorrichtung gefertigt sein.
Dieses Dokument legt nicht die Gestaltung des Selbstblockierungsbauteils einer Spritze fest.
Dieses Dokument gilt nicht für Insulinspritzen (behandelt in ISO 8537), Spritzen für Druckinfusionsapparate (behandelt in ISO 7886 2), Spritzen mit Vorrichtung zur Verhinderung der Wiederverwendung (behandelt in ISO 7886 4) oder zur Vorfüllung ausgelegte Spritzen (behandelt in der Normenreihe ISO 11040). Es behandelt nicht die Verträglichkeit mit Injektionsflüssigkeiten bzw. Impfstoffen.
Seringues hypodermiques stériles, non réutilisables - Partie 3: Seringues autobloquantes pour vaccination à dose fixe (ISO 7886-3:2020)
Le présent document spécifie les propriétés et les performances des seringues hypodermiques stériles, non réutilisables, dotées d'un système autobloquant, prévues pour délivrer une dose fixe de vaccin immédiatement après remplissage. Les seringues peuvent être en plastique, en caoutchouc et en d'autres matériaux et peuvent être avec ou sans aiguille et avec ou sans dispositifs de protection contre les piqûres d'aiguilles.
Le présent document ne spécifie pas la conception du système autobloquant.
Le présent document n'est pas applicable aux seringues à insuline (couvertes par l'ISO 8537), aux seringues pour pousse-seringues électriques (couvertes par l'ISO 7886‑2), aux seringues avec dispositif empêchant la réutilisation (couvertes par l'ISO 7886‑4) ou aux seringues conçues pour être préremplies (couvertes par la série ISO 11040). Il n'aborde pas le problème de la compatibilité avec les liquides injectables et les vaccins.
Sterilne podkožne injekcijske brizge za enkratno uporabo - 3. del: Brizge za točno določen odmerek imunizacije s sistemom za samouničenje (ISO 7886-3:2020)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 7886-3:2020
01-julij-2020
Nadomešča:
SIST EN ISO 7886-3:2010
Sterilne podkožne injekcijske brizge za enkratno uporabo - 3. del: Brizge za točno
določen odmerek imunizacije s sistemom za samouničenje (ISO 7886-3:2020)
Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose
immunization (ISO 7886-3:2020)
Sterile Einmalspritzen für medizinische Zwecke - Teil 3: Selbstblockierende Spritzen für
die Injektion mit fixer Impfstoffdosis (ISO 7886-3:2020)
Seringues hypodermiques stériles, non réutilisables - Partie 3: Seringues autobloquantes
pour vaccination à dose fixe (ISO 7886-3:2020)
Ta slovenski standard je istoveten z: EN ISO 7886-3:2020
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 7886-3:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 7886-3:2020
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SIST EN ISO 7886-3:2020
EN ISO 7886-3
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2020
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 7886-3:2009
English Version
Sterile hypodermic syringes for single use - Part 3: Auto-
disabled syringes for fixed-dose immunization (ISO 7886-
3:2020)
Seringues hypodermiques stériles, non réutilisables - Sterile Einmalspritzen für medizinische Zwecke - Teil
Partie 3: Seringues autobloquantes pour vaccination à 3: Selbstblockierende Spritzen für die Injektion mit
dose fixe (ISO 7886-3:2020) fixer Impfstoffdosis (ISO 7886-3:2020)
This European Standard was approved by CEN on 24 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 7886-3:2020 E
worldwide for CEN national Members.
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SIST EN ISO 7886-3:2020
EN ISO 7886-3:2020 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 7886-3:2020
EN ISO 7886-3:2020 (E)
European foreword
This document (EN ISO 7886-3:2020) 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 7886-3:2009.
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 7886-3:2020 has been approved by CEN as EN ISO 7886-3:2020 without any
modification.
3
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SIST EN ISO 7886-3:2020
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SIST EN ISO 7886-3:2020
INTERNATIONAL ISO
STANDARD 7886-3
Second edition
2020-05
Sterile hypodermic syringes for
single use —
Part 3:
Auto-disabled syringes for fixed-dose
immunization
Seringues hypodermiques stériles, non réutilisables —
Partie 3: Seringues autobloquantes pour vaccination à dose fixe
Reference number
ISO 7886-3:2020(E)
©
ISO 2020
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SIST EN ISO 7886-3:2020
ISO 7886-3:2020(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
---------------------- Page: 8 ----------------------
SIST EN ISO 7886-3:2020
ISO 7886-3:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Nomenclature . 2
5 General requirements . 3
6 Extraneous matter . 4
6.1 General . 4
6.2 Limits for acidity or alkalinity . 4
6.3 Limits for extractable metals . 4
7 Lubricant . 4
8 Tolerance on nominal capacity . 4
9 Graduated scale . 5
9.1 Scale . 5
9.2 Position of scale . 5
10 Barrel . 5
10.1 Dimensions . 5
10.2 Barrel flanges . 5
11 Plunger stopper/plunger assembly. 5
11.1 Design . 5
11.2 Fit of the plunger stopper/plunger in the barrel . 6
11.3 Fiducial line . 6
12 Needle . 6
12.1 General . 6
12.2 Integrated needle . 6
12.3 Non-integrated needle . 6
12.4 Sharps protection features . 6
13 Performance . 7
13.1 General . 7
13.2 Dead space . 7
13.3 Freedom from air and liquid leakage . 7
13.4 Auto-disable syringe feature . 7
13.5 Performance after shipping . 7
14 Packaging . 8
14.1 Unit packaging providing sterile barrier . 8
14.2 Multiple unit pack. 8
14.3 User packaging . 8
15 Information supplied by the manufacturer . 8
15.1 General . 8
15.2 Syringes . 8
15.3 Unit packaging providing sterile barrier . 8
15.4 User packaging . 9
15.5 Storage containers . 9
15.6 Transport wrapping .10
Annex A (normative) Method for preparation of extracts .11
Annex B (informative) Test method for forces required to operate piston .12
© ISO 2020 – All rights reserved iii
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SIST EN ISO 7886-3:2020
ISO 7886-3:2020(E)
Annex C (normative) Test method for testing auto-disable syringe feature .14
Bibliography .15
iv © ISO 2020 – All rights reserved
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SIST EN ISO 7886-3:2020
ISO 7886-3:2020(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, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 7886-3:2005), which has been technically
revised. The main changes compared to the previous edition are as follows:
— update of the references, mainly ISO 7886-1:2017.
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 7886-3:2020
ISO 7886-3:2020(E)
Introduction
ISO 7886 was first published in 1984. It was subsequently decided to divide it into two parts: ISO 7886-1
retaining essentially the scope of ISO 7886:1984 and ISO 7886-2 being applicable to sterile, single-use
syringes for use with power-driven pumps.
The preparation of this document was recognized as a high priority to prevent the reuse of fixed dose
immunization syringes. Reuse of injection equipment in the absence of sterilization has increasingly led
to transmission of blood-borne pathogens.
The World Health Organization (WHO) had produced a specification for syringes that are rendered
inactive after one use (commonly referred to as “auto-disabled” syringes). It was agreed that an
additional part of the ISO 7886 series would be needed to cover “auto-disabled” syringes, while leaving
in place ISO 7886-1 and ISO 7886-2 without modification, as a large number of devices in common use
would not be intended to conform with the auto-disable properties suggested.
It has been discussed to limit the syringe types to only comprise the type having an auto-disable
syringe feature that is automatically activated and remains effective from the time that the injection
is commenced. An assessment of potential hazards based only on hypothetical use indicates that the
type having an auto-disable syringe feature that is automatically activated and remains effective from
the time of the injection being initiated is potentially safer than the other types. However, no consensus
could be reached on either deleting types or retaining them, as no reliable risk data from field use
exists at present. It was therefore agreed to retain all types and restrict this revision to alignment with
ISO 7886-1:2017 and initiate a new revision if new field studies or incident reports indicate a need for a
revision.
It is recognized that syringes designed to reduce the risk of needle stick injuries can also conform with
this document.
In some countries national regulations might take precedence over the requirements in this document.
Guidance on transition periods for implementing the requirements of this document is given in
ISO/TR 19244.
vi © ISO 2020 – All rights reserved
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SIST EN ISO 7886-3:2020
INTERNATIONAL STANDARD ISO 7886-3:2020(E)
Sterile hypodermic syringes for single use —
Part 3:
Auto-disabled syringes for fixed-dose immunization
1 Scope
This document specifies the properties and performance of sterile single-use hypodermic syringes with
an auto-disable syringe feature intended to deliver a fixed dose of vaccine immediately after filling.
The syringes can be made of plastic, rubber or other materials and can be with or without needle and
needle protection feature.
This document does not specify the design of the auto-disable syringe feature.
This document is not applicable to syringes for use with insulin (covered by ISO 8537), syringes for
use with power-driven syringe pumps (covered by ISO 7886-2), reuse prevention syringes (covered by
ISO 7886-4) or syringes designed to be prefilled (covered by the ISO 11040 series). It does not address
compatibility with injection fluids/vaccines.
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 7864:2016, Sterile hypodermic needles for single use — Requirements and test methods
ISO 7886-1:2017, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 8537:2016, Sterile single-use syringes, with or without needle, for insulin
ISO 9626, Stainless steel needle tubing for the manufacture of medical devices — Requirements and
test methods
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14971, Medical devices — Application of risk management to medical devices
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
ASTM D999-01, Standard methods for vibration testing of shipping containers
ASTM D5276-98, Standard test method for drop test of loaded containers by free fall
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 7886-1 and ISO 8537 and the
following apply.
© ISO 2020 – All rights reserved 1
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SIST EN ISO 7886-3:2020
ISO 7886-3:2020(E)
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
auto-disable syringe feature
feature that passively activates upon delivering injection of the nominal fixed dose to prevent
subsequent reuse of the syringe and the needle
Note 1 to entry: A passive activation is an activation of the reuse prevention feature that does not require an
additional step by the user, separate from any action needed to perform the primary intended injection function
of the device.
Note 2 to entry: An active activation is an activation of the reuse prevention feature that does require an
additional step by the user.
3.2
integrated needle
stainless steel cannula directly bonded into the barrel of the syringe
3.3
non-integrated needle
hypodermic needle attached either by the manufacturer or by the user prior to making an injection
3.4
normal conditions of use
operation of the device by any user according to its instructions for use
4 Nomenclature
The nomenclature for components of auto-disable syringes for fixed dose is shown in Figure 1.
2 © ISO 2020 – All rights reserved
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SIST EN ISO 7886-3:2020
ISO 7886-3:2020(E)
Key
1 needle cap or shield (if used) 8 fiducial line
2 needle 9 seal(s)
3 zero line 10 barrel flanges (finger grips)
4 barrel 11 plunger
5 auto-disable syringe feature 12 push-button
6 nominal capacity line 13 plunger cap (if used)
7 plunger stopper
NOTE The figure is intended to illustrate the components of an auto-disabled syringe only.
Figure 1 — Schematic representation of auto-disabled syringe for fixed dose
5 General requirements
The general requirements listed below are considered to be design input for manufacturers.
a) Syringes shall be free from defects affecting appearance, safety and serviceability for their
intended use. 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 requirements 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. This document does not specify
materials to be used for the construction and lubrication of the device, because their selection will
© ISO 2020 – All rights reserved 3
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SIST EN ISO 7886-3:2020
ISO 7886-3:2020(E)
depend, to some extent, upon the manufacturer’s specific syringe design, process of manufacture
and sterilization method.
b) Syringes with integrated or add-on sharps protection shall conform with ISO 23908.
c) The length of the barrel shall allow the expulsion of any air bubbles without removal of the plunger
stopper and still inject nominal capacity. The length of the barrel shall be designed to enable
accurate dosage while avoiding unnecessary waste of vaccine.
d) Biocompatibility of the syringe shall be established in accordance with ISO 10993-1.
e) The auto-disabled syringe shall be of adequate size, shape and strength for the delivery of vaccine
under normal condition of use. The design specifications for the device shall be determined through
risk analysis and confirmed through usability validation testing.
f) The forces required to use a syringe with auto-disable syringe feature shall be appropriate for
the intended users of the device. Although the activation of the auto-disable syringe feature itself
is passive, an appropriate force shall be selected that eases the initiation of the injection. The
appropriate initiation force shall be determined using a risk-based approach in accordance with
ISO 14971.
6 Extraneous matter
6.1 General
The requirements specified in ISO 7886-1:2017, 6.1, apply.
6.2 Limits for acidity or alkalinity
The requirements specified in ISO 7886-1:2017, 6.2, apply except that the extracts shall be prepared in
accordance with Annex A of this document.
6.3 Limits for extractable metals
The requirements specified in ISO 7886-1:2017, 6.3, apply.
7 Lubricant
The requirements specified in ISO 7886-1:2017, Clause 7 and ISO 7864:2016, 4.10.4, apply.
8 Tolerance on nominal capacity
The volume of water at (23 ± 5) °C expelled from the syringe when the fiducial line of the piston traverses
the full scale (i.e. the nominal fixed dose) shall be within the tolerances on the nominal capacity as
specified in Table 1. The nominal capacity shall be designated in millilitres.
4 © ISO 2020 – All rights reserved
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SIST EN ISO 7886-3:2020
ISO 7886-3:2020(E)
Table 1 — Nominal capacity and dead space
Nominal Tolerance Maximum Maximum Maximum Minimal
capacity on nominal dead space for dead space for displacement graduation
capacity integrated nee- non-integrated of position length
dle needle of scale between the
fiducial line
and fixed dose
ml % ml ml % mm
0,05 ml up to ±20 % 0,02 0,025 ±20 % 2
0,2 ml
> 0,2 ml up to ±5 % 0,07 0,07 ±5 % 5
0,5 ml
> 0,5 ml up to ±
...
SLOVENSKI STANDARD
oSIST prEN ISO 7886-3:2019
01-julij-2019
Sterilne podkožne injekcijske brizge za enkratno uporabo - 3. del: Brizge za točno
določen odmerek imunizacije s sistemom za samouničenje (ISO/DIS 7886-3:2019)
Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose
immunization (ISO/DIS 7886-3:2019)
Sterile Einmalspritzen für medizinische Zwecke - Teil 3: Selbstblockierende Spritzen für
die Injektion mit fixer Impfstoffdosis (ISO/DIS 7886-3:2019)
Seringues hypodermiques stériles, non réutilisables - Partie 3: Seringues autobloquantes
pour vaccination à dose fixe (ISO/DIS 7886-3:2019)
Ta slovenski standard je istoveten z: prEN ISO 7886-3
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 7886-3:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 7886-3:2019
---------------------- Page: 2 ----------------------
oSIST prEN ISO 7886-3:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 7886-3
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2019-05-17 2019-08-09
Sterile hypodermic syringes for single use —
Part 3:
Auto-disabled syringes for fixed-dose immunization
Seringues hypodermiques stériles, non réutilisables —
Partie 3: Seringues autobloquantes pour vaccination à dose fixe
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 7886-3:2019(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 7886-3:2019
ISO/DIS 7886-3:2019(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
---------------------- Page: 4 ----------------------
oSIST prEN ISO 7886-3:2019
ISO/DIS 7886-3:2019(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Nomenclature . 2
5 General requirements . 3
6 Extraneous matter . 4
7 Limits for acidity or alkalinity. 4
8 Limits for extractable metals . 4
9 Lubricant . 4
10 Tolerance on nominal capacity . 4
11 Graduated scale . 5
11.1 Scale . 5
11.2 Position of scale . 5
12 Barrel . 5
12.1 Dimensions . 5
12.2 Barrel flanges . 5
13 Plunger stopper/plunger assembly. 5
13.1 Design . 5
13.2 Fit of the plunger stopper/plunger in the barrel . 6
13.3 Fiducial line . 6
14 Needle . 6
14.1 General . 6
14.2 Integrated needle . 6
14.3 Non-integrated needle . 6
14.4 Sharps protection features . 6
15 Performance . 6
15.1 General . 6
15.2 Dead space . 6
15.3 Freedom from air and liquid leakage . 7
15.4 Auto-disable feature . 7
15.5 Performance after shipping . 7
16 Packaging . 7
16.1 Unit packaging providing sterile barrier . 7
16.2 Multiple unit pack. 7
16.3 User packaging . 7
17 Information supplied by the manufacturer . 8
17.1 General . 8
17.2 Syringes . 8
17.3 Unit packaging providing sterile barrier . 8
17.4 The user packaging shall bear at least the following information: . 8
17.5 Storage containers . 9
17.6 Transport wrapping . 9
Annex A (normative) Method for preparation of extracts .11
Annex B (informative) Test method for forces required to operate piston .12
© ISO 2019 – All rights reserved iii
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oSIST prEN ISO 7886-3:2019
ISO/DIS 7886-3:2019(E)
Annex C (normative) Test method for testing auto-disable feature .14
Bibliography .15
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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 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 7886-3:2005), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— updated references to other standards, mainly to the new version of ISO 7886-1:2017.
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
ISO 7886 was first published in 1984. It was subsequently decided to divide it into two parts: ISO 7886-1
retaining essentially the scope of ISO 7886:1984, and ISO 7886-2 being applicable to sterile, single-use
syringes for use with power-driven pumps.
The preparation of this document was recognized as a high priority requirement to prevent the re-use
of fixed dose immunization syringes in the developing and transitional countries. Re-use of injection
equipment in the absence of sterilization has increasingly led to transmission of blood-borne pathogens.
The World Health Organization (WHO) had produced a specification for syringes that are rendered
inactive after one use (commonly referred to as “auto-disabled” syringes). Both the WHO and ISO agreed
that an additional part of ISO 7886 would be required to cover “auto-disabled” syringes, while leaving
in place ISO 7886-1 and ISO 7886-2 without modification, as a large number of devices in common use
would not be intended to comply with the auto-disable properties suggested.
This document is intended to cover “fixed dose” immunization syringes that are passively rendered
non- reusable for another application after the commencement of injection intended to deliver a nominal
vaccine dose. These syringes are not covered by ISO 7886-1 and ISO 7886-2.
It has been discussed to limit the syringe types to only comprise the type having an auto-disable feature
that is automatically activated and remains effective from the time that the injection is commenced. A
risk assessment based only on hypothetical perception that the type having an auto-disable feature
that is automatically activated and remains effective from the time of the injection being initiated is
potentially safer than the other types. However, no consensus could be reached on either deleting types
or retaining them as no reliable risk data from field use exist at present. It was therefore agreed to
retain all types and restrict this revision to alignment with the resent version of ISO 7886-1 and initiate
a new revision if new field studies or incidents reports indicate a need for a revision.
It is recognized that syringes designed to reduce the risk of needle stick injuries may also comply
with this document with regard to their auto-disable properties, but it is stressed that needle stick
protection features of syringes are not in themselves addressed in this document. Requirements for
sharps injury protection features are covered by ISO 23908.
In some countries national regulations are legally binding and the requirements may take precedence
over this document.
Guidance on transition periods for implementing the requirements of this document is given in ISO/
TR 19244.
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oSIST prEN ISO 7886-3:2019
DRAFT INTERNATIONAL STANDARD ISO/DIS 7886-3:2019(E)
Sterile hypodermic syringes for single use —
Part 3:
Auto-disabled syringes for fixed-dose immunization
1 Scope
This document specifies the properties and performance of sterile single-use hypodermic syringes
with or without needle, made of plastic, rubber or other materials and intended for the filling and the
injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine, the syringe is
automatically rendered unusable.
This document does not specify the design of the auto-disable feature, which is left to the discretion of
the manufacturer.
This document is not applicable to syringes for use with insulin (specified in ISO 8537), syringes for
use with power-driven syringe pumps (specified in ISO 7886-2), reuse prevention syringes (specified
in ISO 7886-4) and syringes designed to be prefilled. It does not address compatibility with injection
fluids/vaccines.
NOTE Prefilled syringes are covered in the ISO 11040- series.
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 7000, Graphical symbols for use on equipment — Registered symbols
ISO 7864:2016, Sterile hypodermic needles for single use — Requirements and test methods
ISO 7886-1:2017, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 8537:2016, Sterile single-use syringes, with or without needle, for insulin
ISO 9626, Stainless steel needle tubing for the manufacture of medical devices — Requirements and
test methods
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14971, Medical devices — Application of risk management to medical devices
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
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
ASTM D999-01, Standard methods for vibration testing of shipping containers
ASTM D5276-98, Standard test method for drop test of loaded containers by free fall
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3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 7886-1 and ISO 8537 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
auto-disable syringe feature
feature that passively activates upon delivering injection of the nominal fixed dose to prevent
subsequent re-use of the syringe and the needle
3.2
passive action
activation of the reuse prevention feature that does not require an additional step by the user, separate
from any action needed to perform the primary intended injection function of the device
3.3
active activation
activation of the reuse prevention feature that does require an additional step by the user
3.4
normal conditions of use
operation of the device by any user according to its instructions for use
3.5
integrated needle
stainless steel cannula that is directly bonded into the barrel of the syringe
3.6
non-integrated needle
a hypodermic needle that is attached by the user prior to making an injection
3.7
barrel flanges
flanges that protrude from the barrel (also referred to as finger grips) to provide the user a means of
gripping the syringe during injection
3.8
needle cap or shield
sheath intended to physically protect the needle prior to use
4 Nomenclature
The nomenclature for components of auto-disable syringes for fixed dose is shown in Figure 1.
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Key
1 needle cap or shield (if used) 8 fiducial line
2 needle 9 seal(s)
3 zero line 10 barrel flanges (finger grips)
4 barrel 11 plunger
5 auto-disable feature 12 push-button
6 nominal capacity line 13 plunger cap (if used)
7 plunger stopper
NOTE The drawing is intended to be illustrative of components of an auto-disabled syringe only.
Figure 1 — Schematic representation of auto-disabled syringe for fixed dose
5 General requirements
The general requirements listed below are considered to be design input for manufacturers:
a) syringes shall be free from defects affecting appearance, safety and serviceability for their intended
use. 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. This document does
not specify materials to be used for the construction and lubrication of the device, because their
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selection will depend, to some extent, upon the manufacturer’s specific syringe design, process of
manufacture and sterilization method.
b) syringes with integrated or add-on sharps protection shall comply with ISO 23908.
c) the length of the barrel shall allow the expulsion of any air bubbles without removal of the plunger
stopper and still inject nominal capacity. The length of the barrel shall be designed to enable
accurate dosage while avoiding unnecessary waste of vaccine.
d) the materials used in the syringe shall be tested and qualified according to ISO 10993-1.
e) the auto-disabled syringe shall be of adequate size, shape and strength for the delivery of vaccine
under normal condition of use. The design specifications for the device shall be determined through
risk analysis and confirmed through usability validation testing.
f) the forces required to use a syringe with auto-disable feature shall be appropriate for the
intended users of the device. Although the activation of the auto-disable feature itself is passive,
an appropriate force shall be selected that eases the initiation of the injection. The appropriate
initiation force shall be determined using a risk-based approach in accordance with ISO 14971
6 Extraneous matter
The requirements specified in ISO 7886-1:2017, 6.1 apply.
7 Limits for acidity or alkalinity
The requirements specified in ISO 7886-1:2017, 6.2 apply.
8 Limits for extractable metals
The requirements specified in ISO 7886-1:2017, 6.3 apply.
9 Lubricant
The requirements specified in ISO 7886-1:2017, Clause 7 and ISO 7864:2016, 4.10.4 apply.
10 Tolerance on nominal capacity
The volume of water at (23 ± 5) °C expelled from the syringe when the fiducial line of the piston traverses
the full scale (i.e. the nominal fixed dose) shall be within the tolerances on the nominal capacity as
specified in Table 1. The nominal capacity shall be designated in millilitres.
Table 1 — Nominal capacity and dead space
Nominal capacity Tolerance Maximum dead Maximum dead Maximum Minimal grad-
on nominal space for inte- space for non- in- displacement uation length
ml
capacity grated needle tegrated needle of position of between the
scale fiducial line and
% ml ml
fixed dose
%
mm
0,05ml up to 0,2ml ± 20 % 0,02 0,025 ± 20 % 2
>0,2ml up to 0,5ml ± 5 % 0,07 0,07 ± 5 % 5
>0,5ml up to 1,0 ± 5 % 0,07 0,07 ± 5 % 10
ml
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11 Graduated scale
11.1 Scale
The scale shall have two markings only: the zero line and the nominal capacity line (i.e. the total
graduated capacity line). These lines shall be of uniform thickness. They shall lie in planes at right
angles to the axis of the barrel.
11.2 Position of scale
When the plunger stopper is fully inserted, the zero line of the scale shall coincide with the fiducial line
on the plunger stopper in order to achieve the graduated capacity tolerance as specified in Table 1.
12 Barrel
12.1 Dimensions
The length of the barrel and the design of the auto-disable feature shall be such that the maximum
usable capacity shall not exceed the nominal capacity by 25 %.
12.2 Barrel flanges
The requirements specified in ISO 7886-1:2017, 10.2 apply.
13 Plunger stopper/plunger assembly
13.1 Design
The design of the plunger and push-button of the syringe shall be such that, when the barrel is held in
one hand, the plunger can be depressed by the thumb of that hand. The plunger stopper shall not become
detached from the plunger when tested in accordance with ISO 8537:2016, Annex B, for a syringe with
integrated needle or in accordance with ISO 7886-1:2017, Annex B for a syringe without needle.
The plunger should be of a length adequate to allow the piston to properly deliver the nominal fixed
dose. It should not be possible to defeat the auto-disable feature by removing and re-inserting the
plunger.
The projection of the plunger and the configuration of the push-button should be such as to allow the
plunger to be operated without difficulty. When the fiducial line of the plunger stopper coincides with
the zero graduation line, the preferred minimum length of the plunger from the surface of the barrel
flanges nearer to the push-button, as shown in Figure 1, shall be 8 mm.
Key
1 Minimum length (8 mm) of the plunger from the surface of the barrel flanges nearer to the push-button
Figure 2 — Minimum length between barrel flanges and plunger push-button
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13.2 Fit of the plunger stopper/plunger in the barrel
The requirements specified in ISO 7886-1:2017, 13.4, apply.
NOTE Annex B gives a suggested test method and performance criteria for the forces required to move the
plunger.
13.3 Fiducial line
The requirements specified in ISO 7886-1:2017, 9.4 apply.
14 Needle
14.1 General
The requirements for needle tubing specified in ISO 9626 apply.
14.2 Integrated needle
Syringes with integrated needle
...
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