EN ISO 7886-4:2006

Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)

2005-04-05 - Work item transferred from 00205167 following resolution 2 of the 25th BT/TCMG

Sterile Einmalspritzen für medizinische Zwecke - Teil 4: Spritzen mit Vorrichtung zur Verhinderung der Wiederverwendung (ISO 7886-4:2006)

Dieser Teil von ISO 7886 legt Anforderungen für sterile Einmalspritzen aus Kunststoff mit oder ohne Kanüle fest, die für das Aufziehen von Flüssigkeiten oder für die Injektion von Flüssigkeiten unmittelbar nach ihrem Befüllen vorgesehen und so gestaltet sind, dass die Spritze nach dem Gebrauch unbrauchbar gemacht werden kann.
Dieser Teil von ISO 7886 ist nicht anwendbar auf Glasspritzen (festgelegt in ISO 595), selbstblockierende Spritzen für die Injektion mit fixer Impfstoffdosis (festgelegt in ISO 7886 3) und zur Vorfüllung ausgelegte Spritzen. Er behandelt nicht die Verträglichkeit mit Injektionsflüssigkeiten. Wenn Spritzen für andere Anwen¬dungsbereiche verwendet werden, können andere als die in diesem Teil von ISO 7886 festgelegten Normen herangezogen werden.
ANMERKUNG   Spritzen, die zur Reduzierung des Verletzungsrisikos durch die Einstichnadel ausgelegt sind, können hinsichtlich ihrer Eigenschaften zur Verhinderung der Wiederverwendung auch mit diesem Teil von ISO 7886 überein¬stimmen. Es ist jedoch festzuhalten, dass andere Eigenschaften der Einstichnadel von Spritzen in diesem Teil von ISO 7886 nicht behandelt werden.

Seringues hypodermiques stériles, non réutilisables - Partie 4: Seringues avec dispositif empêchant la réutilisation (ISO 7886-4:2006)

Sterilne podkožne injekcijske brizge za enkratno uporabo - 4. del: Injekcije, katerih značilnosti preprečujejo ponovno uporabo (ISO 7886-4:2006)

General Information

• Status: Withdrawn
• Publication Date: 30-Sep-2006
• Withdrawal Date: 22-Sep-2009
• ICS: 11.040 - Medical equipment
• Technical Committee: CEN/SS S03 - Syringes
• Drafting Committee: CEN/SS S03 - Syringes
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 23-Sep-2009
• Completion Date: 23-Sep-2009
• 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 7886-4:2007 - Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)

Relations

• Replaced By: EN ISO 7886-4:2009 - Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)
• Effective Date: 26-Sep-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 7886-4:2007
01-oktober-2007
6WHULOQHSRGNRåQHLQMHNFLMVNHEUL]JH]DHQNUDWQRXSRUDERGHO,QMHNFLMHNDWHULK
]QDþLOQRVWLSUHSUHþXMHMRSRQRYQRXSRUDER,62
Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention
feature (ISO 7886-4:2006)
Sterile Einmalspritzen für medizinische Zwecke - Teil 4: Spritzen mit Vorrichtung zur
Verhinderung der Wiederverwendung (ISO 7886-4:2006)
Seringues hypodermiques stériles, non réutilisables - Partie 4: Seringues avec dispositif
empechant la réutilisation (ISO 7886-4:2006)
Ta slovenski standard je istoveten z: EN ISO 7886-4:2006
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 7886-4:2007 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 7886-4

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2006
ICS 11.040.25
English Version
Sterile hypodermic syringes for single use - Part 4: Syringes with
re-use prevention feature (ISO 7886-4:2006)
Seringues hypodermiques stériles, non réutilisables - Partie Sterile Einmalspritzen für medizinische Zwecke - Teil 4:
4: Seringues avec dispositif empêchant la réutilisation (ISO Spritzen mit Vorrichtung zur Verhinderung der
7886-4:2006) Wiederverwendung (ISO 7886-4:2006)
This European Standard was approved by CEN on 19 August 2006.

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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.

CEN members are the national standards bodies of Austria, Belgium, 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: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7886-4:2006: E
worldwide for CEN national Members.

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EN ISO 7886-4:2006 (E)





Foreword


This document (EN ISO 7886-4:2006) has been prepared by Technical Committee ISO/TC 84
"Medical devices for injections" in collaboration with CMC.

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 April 2007, and conflicting national standards shall
be withdrawn at the latest by April 2007.

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 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, 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.


Endorsement notice

The text of ISO 7886-4:2006 has been approved by CEN as EN ISO 7886-4:2006 without any
modifications.

2

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EN ISO 7886-4:2006 (E)



ANNEX ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC 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 one means of conforming to
Essential Requirements of the New Approach Directive 93/42/EEC Medical devices.

Once this standard is cited in the Official Journal of the European Communities under that Directive
and has been implemented as a national standard in at least one Member State, compliance with
the normative clauses of this standard given in Table ZA.1 confers, within t
...