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This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], auto-disable syringes for fixed dose immunization (ISO 7886‑3) and syringes designed to be pre-filled.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
Publication Date
05-Mar-2019
Withdrawal Date
29-Sep-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
06-Mar-2019
Completion Date
06-Mar-2019

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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.

---------------------- Page: 1 ----------------------

SIST EN ISO 7886-4:2019

---------------------- Page: 2 ----------------------

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.

---------------------- Page: 3 ----------------------

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

2

---------------------- Page: 4 ----------------------

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
...

SLOVENSKI STANDARD
oSIST prEN ISO 7886-4:2018
01-januar-2018
6WHULOQHSRGNRåQHLQMHNFLMVNHEUL]JH]DHQNUDWQRXSRUDERGHO,QMHNFLMHNDWHULK
]QDþLOQRVWLSUHSUHþXMHMRSRQRYQRXSRUDER ,62',6
Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention
feature (ISO/DIS 7886-4:2017)
Sterile Injektionskanülen für den Einmalgebrauch - Teil 4: Spritzen mit Vorrichtung zur
Verhinderung der Wiederverwendung (ISO/DIS 7886-4:2017)
Seringues hypodermiques stériles, non réutilisables - Partie 4: Seringues avec dispositif
empêchant la réutilisation (ISO/DIS 7886-4:2017)
Ta slovenski standard je istoveten z: prEN ISO 7886-4
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 7886-4:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 7886-4:2018

---------------------- Page: 2 ----------------------
oSIST prEN ISO 7886-4:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 7886-4
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2017-10-20 2018-01-12
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
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 7886-4:2017(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 2017

---------------------- Page: 3 ----------------------
oSIST prEN ISO 7886-4:2018
ISO/DIS 7886-4:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 7886-4:2018
ISO/DIS 7886-4:2017(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 .
...

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