SIST EN ISO 7886-4:2019

Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2018)

This document specifies requirements for sterile single-use hypodermic syringes made of plastic and
rubber materials with or without needle, and intended for the aspiration of fluids or for the injection of
fluids immediately after filling and of design such that the syringe can be rendered unusable after use.
This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], autodisable
syringes for fixed dose immunization (ISO 7886-3) and syringes designed to be pre-filled. It
does not address compatibility with injection fluids. Other standards can be applicable when syringes
are used for any other intended purpose than those specified in this document.
NOTE Syringes designed to reduce the risk of needle-stick injuries can also comply with this document with
regard to their re-use prevention properties, but it is stressed that anti-needle-stick properties of syringes are
not in themselves addressed in this document.

Sterile Injektionskanülen für den Einmalgebrauch - Teil 4: Spritzen mit Vorrichtung zur Verhinderung der Wiederverwendung (ISO 7886-4:2018)

Seringues hypodermiques stériles, non réutilisables - Partie 4: Seringues avec dispositif empêchant la réutilisation (ISO 7886-4:2018)

Le présent document spécifie les exigences relatives aux seringues hypodermiques stériles non réutilisables, en matière plastique et en caoutchouc, avec ou sans aiguille, prévues pour aspirer des liquides ou pour en injecter immédiatement après remplissage, leur conception faisant que la seringue est rendue inutilisable après utilisation.
Le présent document ne s'applique pas aux seringues en verre [spécifiées dans l'ISO 595 (retirée)], aux seringues autobloquantes pour vaccination à dose fixe (ISO 7886‑3) et aux seringues conçues pour être préremplies. Il n'aborde pas le problème de la compatibilité avec les liquides injectables. Si la seringue est utilisée à une autre fin prévue que celle spécifiée dans le présent document, d'autres normes peuvent être applicables.
NOTE       Les seringues conçues pour réduire les risques de blessures dues à des piqûres d'aiguille peuvent également être conformes au présent document en ce qui concerne leurs propriétés empêchant la réutilisation; il est toutefois à souligner que les propriétés de protection contre les piqûres d'aiguille ne sont pas en tant que telles traitées dans le présent document.

Sterilne podkožne injekcijske brizge za enkratno uporabo - 4. del: Injekcije, katerih značilnosti preprečujejo ponovno uporabo (ISO 7886-4:2018)

Ta dokument določa zahteve za sterilne podkožne injekcijske brizge, izdelane iz plastike in
gume, z iglo ali brez nje, ki so namenjene za aspiracijo ali injiciranje tekočin takoj po polnjenju in so zasnovane tako, da jih po uporabi ni več mogoče uporabljati.
Ta dokument se ne uporablja za injekcijske brizge, izdelane iz stekla (določene v standardu ISO 595 (razveljavljen)), injekcijske brizge za imunizacijo s točno določenim odmerkom s sistemom za samouničenje (ISO 7886-3) in injekcijske brizge, ki so zasnovane za vnaprejšnje polnjenje. Ne obravnava združljivosti z injekcijskimi tekočinami. Kadar se injekcijske brizge uporabljajo za kakršen koli drug predviden namen, ki ni določen v tem dokumentu, se lahko uporabljajo drugi standardi.
OPOMBA: Injekcijske brizge, ki so zasnovane za zmanjšanje nevarnosti poškodb pri vbodu igle, so prav tako lahko v skladu s tem dokumentom glede svojih lastnosti preprečevanja ponovne uporabe, vendar je treba poudariti, da lastnosti, ki preprečujejo poškodbe pri vbodu igle, same po sebi niso obravnavane v tem dokumentu.

General Information

• Status: Published
• Public Enquiry End Date: 09-Jan-2018
• Publication Date: 08-Apr-2019
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 18-Mar-2019
• Due Date: 23-May-2019
• Completion Date: 09-Apr-2019
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 7886-4:2019 - Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2018)

Relations

• Replaces: SIST EN ISO 7886-4:2010 - Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)
• Effective Date: 01-May-2019
• Replaces: SIST EN ISO 7886-4:2010 - Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 7886-4:2019
01-maj-2019
1DGRPHãþD
SIST EN ISO 7886-4:2010
6WHULOQHSRGNRåQHLQMHNFLMVNHEUL]JH]DHQNUDWQRXSRUDERGHO,QMHNFLMHNDWHULK
]QDþLOQRVWLSUHSUHþXMHMRSRQRYQRXSRUDER,62
Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention
feature (ISO 7886-4:2018)
Sterile Injektionskanülen für den Einmalgebrauch - Teil 4: Spritzen mit Vorrichtung zur
Verhinderung der Wiederverwendung (ISO 7886-4:2018)
Seringues hypodermiques stériles, non réutilisables - Partie 4: Seringues avec dispositif
empêchant la réutilisation (ISO 7886-4:2018)
Ta slovenski standard je istoveten z: EN ISO 7886-4:2019
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 7886-4:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7886-4:2019

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SIST EN ISO 7886-4:2019


EN ISO 7886-4
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2019
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 7886-4:2009
English Version

Sterile hypodermic syringes for single use - Part 4:
Syringes with re-use prevention feature (ISO 7886-
4:2018)
Seringues hypodermiques stériles, non réutilisables - Sterile Injektionskanülen für den Einmalgebrauch -
Partie 4: Seringues avec dispositif empêchant la Teil 4: Spritzen mit Vorrichtung zur Verhinderung der
réutilisation (ISO 7886-4:2018) Wiederverwendung (ISO 7886-4:2018)
This European Standard was approved by CEN on 1 March 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7886-4:2019 E
worldwide for CEN national Members.

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SIST EN ISO 7886-4:2019
EN ISO 7886-4:2019 (E)
Contents Page
European foreword . 3
Endorsement notice . 3

2

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SIST EN ISO 7886-4:2019
EN ISO 7886-4:2019 (E)
European foreword
This document (EN ISO 7886-4:2019) 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 2019, and conflicting national standards
shall be withdrawn at the latest by September 2019.
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 7886-4:2009.
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 the relationship with EU Directive(s) see informative Annex ZA, which is an integral part of this
document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 7886-4:2018 has been approved by CEN as EN ISO 7886-4:2019 without any
modification.


3

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SIST EN ISO 7886-4:2019

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SIST EN ISO 7886-4:2019
INTERNATIONAL ISO
STANDARD 7886-4
Second edition
2018-11
Sterile hypodermic syringes for
single use —
Part 4:
Syringes with re-use prevention
feature
Seringues hypodermiques stériles, non réutilisables —
Partie 4: Seringues avec dispositif empêchant la réutilisation
Reference number
ISO 7886-4:2018(E)
©
ISO 2018

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SIST EN ISO 7886-4:2019
ISO 7886-4:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
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: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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SIST EN ISO 7886-4:2019
ISO 7886-4:2018(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Types of syringe. 2
4.1 General . 2
4.2 Types of re-use prevention feature . 2
4.3 Types of intended use/application . 2
5 Extraneous matter . 2
5.1 General . 2
5.2 Limits for acidity or alkalinity . 2
5.3 Limits for extractable metals . 2
6 Lubricant . 3
7 Tolerance on graduated capacity . 3
8 Graduated scale . 3
8.1 Scale . 3
8.2 Numbering of scale . 3
8.3 Position of scale . 3
8.4 Overall length of scale to nominal capacity line . 3
9 Barrel . 3
9.1 Dimensions . 3
9.2 Barrel flanges . 3
10 Plunger stopper/plunger assembly. 3
10.1 Design . 3
10.2 Fit of plunger stopper/plunger in the barrel . 4
10.3 Fiducial line . 4
11 Syringe nozzle/needle . 4
11.1 Syringe with integrated needle . 4
11.2 Syringe with Luer nozzle . 4
12 Performance . 4
12.1 Dead space . 4
12.2 Freedom from air and liquid leakage . 4
12.3 Re-use prevention feature . 5
12.4 Performance after shipping . 5
13 Packaging . 5
13.1 Unit packaging and self-contained syringe units . 5
13.2 Multiple unit pack. 5
13.3 User packaging . 5
14 Information supplied by the manufacturer . 5
14.1 General . 5
14.2 Syringes . 5
14.2.1 General. 5
14.2.2 Unit packaging . 5
14.3 Multiple unit packs . 6
14.3.1 General. 6
14.3.2 Multiple unit packs with self-contained syringes. 6
14.4 User packaging . 6
© ISO 2018 – All rights reserved iii

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SIST EN ISO 7886-4:2019
ISO 7886-4:2018(E)

14.4.1 General. 6
14.4.2 Storage container . 6
14.5 Transport wrapping . 6
Annex A (normative) Method for preparation of extracts . 7
Annex B (normative) Test method for testing re-use prevention feature . 8
Bibliography .10
iv © ISO 2018 – All rights reserved

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SIST EN ISO 7886-4:2019
ISO 7886-4:2018(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 volu
...