EN ISO 7886-3:2009
(Main)Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)
Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)
ISO 7886-3:2005 specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic materials and stainless steel and intended for the aspiration of vaccines or for the injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine the syringe is automatically rendered unusable.
ISO 7886-3:2005 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer
ISO 7886-3:2005 is not applicable to syringes for use with insulin (specified in ISO 8537), syringes made of glass (specified in ISO 595), syringes for use with power-driven syringe pumps (specified in ISO 7886-2), auto-disable syringes for variable dose delivery and syringes designed to be prefilled. 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 7886-3:2005)
Dieser Teil von ISO 7886 legt Eigenschaften und Leistungsmerkmale für sterile Einmalspritzen aus Kunststoff
und nichtrostendem Stahl mit und ohne Kanüle fest, die für das Aufziehen von Impfstoffen oder für die
Injektion von Impfstoffen unmittelbar nach ihrem Befüllen vorgesehen sind. Nach Abgabe einer fixen Impfstoffdosis
wird die Spritze automatisch unbrauchbar.
Dieser Teil von ISO 7886 legt nicht das Design des Selbstblockierungs-Bauteils, welches im Ermessen des
Herstellers liegt, fest.
Dieser Teil von ISO 7886 gilt nicht für Insulinspritzen (festgelegt in ISO 8537), Glasspritzen (festgelegt in
ISO 595), Spritzen für Druckinfusionsapparate (festgelegt in ISO 7886-2), selbstblockierende Spritzen zur
Abgabe unterschiedlicher Dosen und zur Vorfüllung ausgelegte Spritzen. Er behandelt nicht die Verträglichkeit
mit Injektionsflüssigkeiten bzw. Impfstoffen.
ANMERKUNG Ein vierter Teil von ISO 7886 ist in Vorbereitung, der Spritzen mit Vorrichtung zur Verhinderung der
Wiederverwendung (Selbstblockierungs-Bauteil) behandelt.
Seringues hypodermiques stériles, non réutilisables - Partie 3: Seringues autobloquantes pour vaccination à dose fixe (ISO 7886-3:2005)
L'ISO 7886-3:2005 spécifie les propriétés et les performances des seringues hypodermiques stériles, non réutilisables, avec ou sans aiguille, en plastique et en acier inoxydable, prévues pour aspirer des vaccins ou destinées à des injections de vaccins immédiatement après remplissage. L'administration d'une dose fixe de vaccin met automatiquement la seringue hors d'usage.
L'ISO 7886-3:2005 ne spécifie pas la conception du système autobloquant, qui est laissée à la discrétion du fabricant.
L'ISO 7886-3:2005 n'est pas applicable aux seringues à insuline (spécifiées dans l'ISO 8537), aux seringues en verre (spécifiées dans l'ISO 595), aux seringues pour pousse-seringues mus par un moteur (spécifiées dans l'ISO 7886-2), aux seringues autobloquantes pour l'administration de doses variables et aux seringues conçues pour être préremplies. Elle 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 7886-3:2005)
Ta del ISO 7886 določa lastnosti in delovanje sterilnih podkožnih injekcijskih brizg za enkratno uporabo z iglo ali brez nje, ki so narejene iz plastičnih materialov in nerjavečega jekla in se uporabljajo za aspiracijo cepiv ali injiciranje cepiv takoj po polnitvi. Po vnosu točno določenega odmerka cepiva injekcijska brizga avtomatsko postane neuporabna. Ta del ISO 7886 ne določa načina za samouničenje, kar je prepuščeno presoji proizvajalca. Ta del ISO 7886 ne velja za injekcijske brizge, ki se uporabljajo z inzulinom (opredeljene v ISO 8537), steklene injekcijske brizge (opredeljene v ISO 595), injekcijske brizge, ki se uporabljajo z gnanimi brizgalnimi črpalkami (opredeljene v ISO 7886-2), injekcijske brizge za dovajanje spremenljivih odmerkov s sistemom za samouničenje in injekcijske brizge, ki se polnijo vnaprej. Ne obravnava skladnosti s tekočinami za injiciranje/cepiva.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2010
1DGRPHãþD
SIST EN ISO 7886-3:2005
6WHULOQHSRGNRåQHLQMHNFLMVNHEUL]JH]DHQNUDWQRXSRUDERGHO %UL]JH]DWRþQR
GRORþHQRGPHUHNLPXQL]DFLMHVVLVWHPRP]DVDPRXQLþHQMH ,62
Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose
immunization (ISO 7886-3:2005)
Sterile Einmalspritzen für medizinische Zwecke - Teil 3: Selbstblockierende Spritzen für
die Injektion mit fixer Impfstoffdosis (ISO 7886-3:2005)
Seringues hypodermiques stériles, non réutilisables - Partie 3: Seringues autobloquantes
pour vaccination à dose fixe (ISO 7886-3:2005)
Ta slovenski standard je istoveten z: EN ISO 7886-3:2009
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 7886-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2009
ICS 11.040.25 Supersedes EN ISO 7886-3:2005
English Version
Sterile hypodermic syringes for single use - Part 3: Auto-disable
syringes for fixed-dose immunization (ISO 7886-3:2005)
Seringues hypodermiques stériles, non réutilisables - Partie Sterile Einmalspritzen für medizinische Zwecke - Teil 3:
3: Seringues autobloquantes pour vaccination à dose fixe Selbstblockierende Spritzen für die Injektion mit fixer
(ISO 7886-3:2005) Impfstoffdosis (ISO 7886-3:2005)
This European Standard was approved by CEN on 24 August 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7886-3:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4
Foreword
The text of ISO 7886-3:2005 has been prepared by Technical Committee ISO/TC 84 “Devices for
administration of medicinal products and intravascular catheters” of the International Organization for
Standardization (ISO) and has been taken over as EN ISO 7886-3:2009.
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 March 2010, and conflicting national standards shall be withdrawn at
the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 7886-3:2005.
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.
For relationship with EU Directive, 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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 7886-3:2005 has been approved by CEN as a EN ISO 7886-3:2009 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on
medical devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
5 1, 7.1, 7.2, 7.5 E.R. 7.5 is only partially covered:
protection against risks posed by
the presence of phthalates and
other toxic substances are not
specifically addressed.
6 1, 7.1, 7.2, 7.5 E.R. 7.5 is only partially covered:
protection against risks posed by
the presence of phthalates and
other toxic substances are not
specifically addressed.
7 1, 7.1, 7.2, 7.5 E.R. 7.5 is only partially covered:
protection against risks posed by
the presence of phthalates and
other toxic substances are not
specifically addressed.
8 1, 7.1, 7.2, 7.5 E.R. 7.5 is only partially covered:
protection against risks posed by
the presence of phthalates and
other toxic substances are not
specifically addressed.
9 10.1, 10.3
10 1, 10.1, 10.2, 10.3
11.1 1, 10.1, 10.2
11.2 10.2
12.1 1, 2, 3, 10.2, 12.8.2
12.2 1, 2, 3, 12.8.1, 12.8.2
12.3 10.2
13.1 1, 2
Table ZA.1 (continued)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs)
EN of Directive 93/42/EEC
13.2 1, 2, 9.1
14.1 1, 2, 10.1, 10.3
14.2 1, 2, 7.5, 7.6
14.3 1, 2, 3, 12.8.2, 8.1
14.4 5
15.1 3, 7.2, 8.3, 8,7
15.2 7.2, 8.3, 8,7
16 13.1, 13.2, 13.3, 13.4, 13.5, 13.6 Except 13.3 (f) (second phrase
regarding indication of single use
consistent across community),
except 13.3 (a) (regarding
representative in the
Community),
nd
except 13.6 (h) – 2 phrase
(information on known
characteristics and technical
factors known to manufacturer
that could pose a risk if reused)
and 13.6 (q) (regarding date of
issue or latest revision of
instructions for use)
NOTE 6 a Requirement on clinical
evaluation not covered by this
standard
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 7886-3
First edition
2005-03-01
Sterile hypodermic syringes for single
use —
Part 3:
Auto-disable syringes for fixed-dose
immunization
Seringues hypodermiques stériles, non réutilisables —
Partie 3: Seringues autobloquantes pour vaccination à dose fixe
Reference number
ISO 7886-3:2005(E)
©
ISO 2005
ISO 7886-3:2005(E)
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ii © ISO 2005 – All rights reserved
ISO 7886-3:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 Nomenclature . 2
5 Cleanliness . 3
6 Limits for acidity or alkalinity . 3
7 Limits for extractable metals . 3
8 Lubricant. 3
9 Tolerance on nominal capacity . 3
10 Graduated scale . 3
11 Barrel. 4
12 Piston/plunger assembly. 4
13 Needle. 4
14 Performance . 5
15 Packaging . 6
16 Labelling. 6
Annex A (normative) Method for preparation of extracts . 9
Annex B (informative) Test method for forces required to operate plunger . 10
Annex C (normative) Test method for testing auto-disable feature. 12
Bibliography . 13
iii© ISO 2005 – All rights reserved iii
ISO 7886-3:2005(E)
Foreword
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(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
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