SIST EN ISO 9187-2:2011

Injection equipment for medical use - Part 2: One-point-cut (OPC) ampoules (ISO 9187-2:2010)

This part of ISO 9187 specifies materials, dimensions and requirements for forms of one-point-cut (OPC) ampoules (forms B, C and D) for injectables. Ampoules complying with this part of ISO 9187 are intended for single use only.

Injektionsgeräte zur medizininischen Verwendung - Teil 2: OPC-Ampullen (ISO 9187-2:2010)

Dieser Teil von ISO 9187 legt Werkstoffe, Maße und Anforderungen an drei Formen von OPC-Ampullen (Formen B, C und D) für Injektionspräparate fest.
Ampullen nach diesem Teil von ISO 9187 sind nur zur einmaligen Verwendung bestimmt.

Matériel d'injection à usage médical - Partie 2: Ampoules à un seul point de cassure (OPC) (ISO 9187-2:2010)

L'ISO 9187-2:2010 spécifie les matériaux, les dimensions et les exigences relatives aux types d'ampoules à un seul point de cassure (OPC) (types B, C et D) pour produits injectables.
Les ampoules conformes à l'ISO 9187-2:2010 sont destinées à un usage unique.

Oprema za injiciranje za uporabo v medicini - 2. del: Ampule, ki jih je mogoče odlomiti na označenem mestu (OPC) (ISO 9187-2:2010)

Ta del ISO 9187 določa materiale, dimenzije in zahteve za oblike za ampule, ki jih je mogoče odlomiti na označenem mestu (OPC, oblik B, C in D) za injiciranje. Ampule, ki jih določa ta del ISO 9187, so namenjene le enkratni uporabi.

General Information

• Status: Published
• Public Enquiry End Date: 09-Sep-2010
• Publication Date: 13-Dec-2010
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 30-Nov-2010
• Due Date: 04-Feb-2011
• Completion Date: 14-Dec-2010
• Ref Project: EN ISO 9187-2:2010 - Injection equipment for medical use - Part 2: One-point-cut (OPC) ampoules (ISO 9187-2:2010)

Relations

• Replaces: SIST EN ISO 9187-2:2000 - Injection equipment for medical use - Part 2: One-point-cut (OPC) ampoules (ISO 9187-2:1999)
• Effective Date: 01-Jan-2011
• Replaces: SIST EN ISO 9187-2:2000/AC:2000 - Injection equipment for medical use - Part 2: One-point-cut (OPC) ampoules (ISO 9187-2:1993)
• Effective Date: 01-Jan-2011
• Replaces: SIST EN ISO 9187-2:2000 - Injection equipment for medical use - Part 2: One-point-cut (OPC) ampoules (ISO 9187-2:1999)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 9187-2:2011
01-januar-2011
1DGRPHãþD
SIST EN ISO 9187-2:2000
SIST EN ISO 9187-2:2000/AC:2000
2SUHPD]DLQMLFLUDQMH]DXSRUDERYPHGLFLQLGHO$PSXOHNLMLKMHPRJRþH
RGORPLWLQDR]QDþHQHPPHVWX23&,62
Injection equipment for medical use - Part 2: One-point-cut (OPC) ampoules (ISO 9187-
2:2010)
Injektionsgeräte zur medizininischen Verwendung - Teil 2: OPC-Ampullen (ISO 9187-
2:2010)
Matériel d'injection à usage médical - Partie 2: Ampoules à un seul point de cassure
(OPC) (ISO 9187-2:2010)
Ta slovenski standard je istoveten z: EN ISO 9187-2:2010
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 9187-2:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 9187-2:2011

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SIST EN ISO 9187-2:2011


EUROPEAN STANDARD
EN ISO 9187-2

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2010
ICS 11.040.20 Supersedes EN ISO 9187-2:1999
English Version
Injection equipment for medical use - Part 2: One-point-cut
(OPC) ampoules (ISO 9187-2:2010)
Matériel d'injection à usage médical - Partie 2: Ampoules à Injektionsgeräte zur medizininischen Verwendung - Teil 2:
un seul point de cassure (OPC) (ISO 9187-2:2010) OPC-Ampullen (ISO 9187-2:2010)
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 Ref. No. EN ISO 9187-2:2010: E
worldwide for CEN national Members.

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

2

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SIST EN ISO 9187-2:2011
EN ISO 9187-2:2010 (E)
Foreword
The text of ISO 9187-2:2010 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 9187-2:2010 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 9187-2:1999.
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 9187-2:2010 has been approved by CEN as a EN ISO 9187-2:2010 without any modification.

3

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SIST EN ISO 9187-2:2011

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SIST EN ISO 9187-2:2011

INTERNATIONAL ISO
STANDARD 9187-2
Second edition
2010-10-15

Injection equipment for medical use —
Part 2:
One-point-cut (OPC) ampoules
Matériel d'injection à usage médical —
Partie 2: Ampoules à un seul point de cassure (OPC)




Reference number
ISO 9187-2:2010(E)
©
ISO 2010

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SIST EN ISO 9187-2:2011
ISO 9187-2:2010(E)
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