EN ISO 7886-3:2009

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

• Status: Withdrawn
• Publication Date: 22-Sep-2009
• Withdrawal Date: 19-May-2020
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 20-May-2020
• 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: SIST EN ISO 7886-3:2010 - Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

Relations

• Replaces: EN ISO 7886-3:2005 - Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)
• Effective Date: 28-Jan-2009
• Replaced By: EN ISO 7886-3:2020 - Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization (ISO 7886-3:2020)
• Effective Date: 27-May-2020
• Revised: prEN ISO 7886-3 - Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO/DIS 7886-3:2016)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 7886-3:2010
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
SIST EN ISO 7886-3:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7886-3:2010

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SIST EN ISO 7886-3:2010


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.

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SIST EN ISO 7886-3:2010
EN ISO 7886-3:2009 (E)
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

2

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SIST EN ISO 7886-3:2010
EN ISO 7886-3:2009 (E)
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, Fra
...