EN ISO 9187-1:2010

Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)

ISO 9187-1:2010 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products.
ISO 9187-1:2010 is applicable to ampoules with and without a colour break-ring; the provision of ampoules with a colour break-ring, and the choice of colour of the break-ring, is subject to agreement between the manufacturer and user.
Ampoules complying with ISO 9187-1:2010 are intended for single use only.

Injektionsgeräte zur medizinischen Verwendung - Teil 1: Ampullen für Injektionspräparate (ISO 9187-1:2010)

Dieser Teil von ISO 9187 legt Werkstoffe, Maße, das Volumen, die Leistung und Anforderungen an die Verpackung für drei Formen von Ampullen aus Glas (Formen B, C und D) für Injektionspräparate fest.
Er gilt für Ampullen ohne und mit Farbbrechring; die Bereitstellung von Ampullen mit Farbbrechring und die Wahl der Farbe des Farbbrechrings ist zwischen Hersteller und Anwender zu vereinbaren.
Ampullen nach diesem Teil von ISO 9187 sind nur zur einmaligen Verwendung bestimmt.

Matériel d'injection à usage médical - Partie 1: Ampoules pour produits injectables (ISO 9187-1:2010)

L'ISO 9187-1:2010 spécifie les matériaux, les dimensions, les capacités, ainsi que les exigences relatives à la performance et à l'emballage de trois types d'ampoules en verre (types B, C et D) pour les produits pharmaceutiques injectables.
L'ISO 9187-1:2010 s'applique aux ampoules avec ou sans anneau de cassure coloré; la livraison d'ampoules avec anneau de cassure coloré ainsi que la spécification de la couleur désirée de l'anneau de cassure font l'objet d'un accord entre le fabricant et l'utilisateur.
Les ampoules conformes à l'ISO 9187-1:2010 sont destinées à un usage unique.

Oprema za injiciranje za uporabo v medicini - 1. del: Ampule za paranteralne farmacevtske oblike (ISO 9187-1:2010)

Ta del ISO 9187 določa zahteve za materiale, dimenzije, prostornine, zmogljivost in embalažo za tri oblike steklenih ampul (oblike B, C in D) za farmacevtske izdelke za injiciranje. Velja za ampule z ali brez barvnega obročka; nabava ampul z barvnimi obročki in izbira barv obročka je predmet dogovora med proizvajalcem in uporabnikom. Ampule, ki jih določa ta del ISO 9187, so namenjena le enkratni uporabi.

General Information

• Status: Published
• Publication Date: 14-Oct-2010
• Withdrawal Date: 29-Apr-2011
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/SS S02 - Transfusion equipment
• Drafting Committee: CEN/SS S02 - Transfusion equipment
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 15-Oct-2010
• Completion Date: 15-Oct-2010
• Ref Project: SIST EN ISO 9187-1:2011 - Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)

Relations

• Replaces: EN ISO 9187-1:2008 - Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2006)
• Effective Date: 23-Jan-2010

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Oprema za injiciranje za uporabo v medicini - 1. del: Ampule za paranteralne farmacevtske oblike (ISO 9187-1:2010)Injektionsgeräte zur medizinischen Verwendung - Teil 1: Ampullen für Injektionspräparate (ISO 9187-1:2010)Matériel d'injection à usage médical - Partie 1: Ampoules pour produits injectables (ISO 9187-1:2010)Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:Ta slovenski standard je istoveten z:EN ISO 9187-1:2010SIST EN ISO 9187-1:2011en01-januar-2011SIST EN ISO 9187-1:2011SLOVENSKI
STANDARDSIST EN ISO 9187-1:20081DGRPHãþD



SIST EN ISO 9187-1:2011



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 9187-1
October 2010 ICS 11.040.20 Supersedes EN ISO 9187-1:2008English Version
Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)
Matériel d'injection à usage médical - Partie 1: Ampoules pour produits injectables (ISO 9187-1:2010)
Injektionsgeräte zur medizinischen Verwendung - Teil 1: Ampullen für Injektionspräparate (ISO 9187-1:2010) This European Standard was approved by CEN on 13 October 2010.
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, Croatia, 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 © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9187-1:2010: ESIST EN ISO 9187-1:2011



EN ISO 9187-1:2010 (E) 2 Contents Page Foreword .3 SIST EN ISO 9187-1:2011



EN ISO 9187-1:2010 (E) 3 Foreword The text of ISO 9187-1:2010 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 9187-1:2010 by Technical Committee CEN/TC S02 “Transfusion equipment” the secretariat of which is held by CCMC. 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 2011, and conflicting national standards shall be withdrawn at the latest by April 2011. 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 9187-1:2008. 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, 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 9187-1:2010 has been approved by CEN as a EN ISO 9187-1:2010 without any modification.
SIST EN ISO 9187-1:2011



SIST EN ISO 9187-1:2011



Reference numberISO 9187-1:2010(E)© ISO 2010
INTERNATIONAL STANDARD ISO9187-1Fourth edition2010-10-15Injection equipment for medical use — Part 1: Ampoules for injectables Matériel d'injection à usage médical — Partie 1: Ampoules pour produits injectables
SIST EN ISO 9187-1:2011



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