SIST EN ISO 9187-1:2008

Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2006)

This part of ISO 9187 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products. It 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 this part of ISO 9187 are intended for single use only.

Injektionsgeräte zur medizinischen Verwendung - Teil 1: Ampullen für Injektionspräparate (ISO 9187-1:2006)

Dieser Teil von ISO 9187 legt Werkstoffe, Maße, das Volumen, die Ausführung 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 9187-1:2006)

Oprema za injiciranje za uporabo v medicini - 1. del: Ampule za paranteralne farmacevtske oblike (ISO 9187-1:2006)

General Information

• Status: Withdrawn
• Publication Date: 03-Jun-2008
• Withdrawal Date: 02-Dec-2010
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 02-Dec-2010
• Due Date: 25-Dec-2010
• Completion Date: 03-Dec-2010
• Ref Project: EN ISO 9187-1:2008 - Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2006)

Relations

• Replaces: SIST EN ISO 9187-1:2003 - Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2000)
• Effective Date: 01-Jul-2008
• Replaces: SIST EN ISO 9187-1:2003/AC:2005 - Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2000)
• Effective Date: 01-Jul-2008
• Replaced By: SIST EN ISO 9187-1:2011 - Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)
• Effective Date: 01-Jan-2011
• Replaced By: SIST EN ISO 9187-1:2011 - Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 9187-1:2008
01-julij-2008
1DGRPHãþD
SIST EN ISO 9187-1:2003
SIST EN ISO 9187-1:2003/AC:2005
Oprema za injiciranje za uporabo v medicini - 1. del: Ampule za paranteralne
farmacevtske oblike (ISO 9187-1:2006)
Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2006)
Injektionsgeräte zur medizinischen Verwendung - Teil 1: Ampullen für
Injektionspräparate (ISO 9187-1:2006)
Matériel d'injection à usage médical - Partie 1: Ampoules pour produits injectables (ISO
9187-1:2006)
Ta slovenski standard je istoveten z: EN ISO 9187-1:2008
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 9187-1:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 9187-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2008
ICS 11.040.20 Supersedes EN ISO 9187-1:2003
English Version
Injection equipment for medical use - Part 1: Ampoules for
injectables (ISO 9187-1:2006)
Matériel d'injection à usage médical - Partie 1: Ampoules Injektionsgeräte zur medizinischen Verwendung - Teil 1:
pour produits injectables (ISO 9187-1:2006) Ampullen für Injektionspräparate (ISO 9187-1:2006)
This European Standard was approved by CEN on 7 March 2008.
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: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9187-1:2008: E
worldwide for CEN national Members.

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EN ISO 9187-1:2008 (E)
Contents Page
Foreword.3

2

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EN ISO 9187-1:2008 (E)
Foreword
The text of ISO 9187-1:2006 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 9187-1:2008 by Technical Committee CEN/SS
S02 “Transfusion equipment” the secretariat of which is held by 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 September 2008, and conflicting national standards shall be
withdrawn at the latest by September 2008.
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 9187-1:2003.
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 9187-1:2006 has been approved by CEN as a EN ISO 9187-1:2008 without any modification.

3

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INTERNATIONAL ISO
STANDARD 9187-1
Third edition
2006-04-15
Corrected version
2006-08-01


Injection equipment for medical use —
Part 1:
Ampoules for injectables
Matériel d'injection à usage médical —
Partie 1: Ampoules pour produits injectables





Reference number
ISO 9187-1:2006(E)
©
ISO 2006

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ISO 9187-1:2006(E)
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ii © ISO 2006 – All rights reserved

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ISO 9187-1:2006(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 9187-1 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
This third edition cancels and replaces the second edition (ISO 9187-1:2000), which has undergone a minor
revision with the addition of footnote a) in Table 1.
ISO 9187 consists of the following parts, under the general title Injection equipment for medical use:
⎯ Part 1: Ampoules for injectables
⎯ Part 2: One-point-cut (OPC) ampoules
This corrected version of ISO 9187-1:2006 incorporates the correction of Table 1 on page 4.
© ISO 2006 – All rights reserved iii

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ISO 9187-1:2006(E)
Introduction
Ampoules are suitable packaging materials for storing pharmaceutical products until they are administered to
the patient. Owing to the direct contact between injectables and the primary container over extended storage
periods, possible interactions are avoided in order to guarantee patient safety. Adequate means to achieve
this objective include proper selection of primary packaging materials, the choice of suitable package design
and the availability of specific requirements and methods for testing individual container systems.
In the past, four standardized forms of ampoule (forms A, B, C and D) have been in widespread use. However,
form A is no longer used in the pharmaceutical industry and consequently has not been included in this part of
ISO 9187. To avoid any confusion among manufacturers and users, it was decided to retain the same
designation letters (i.e. B, C and D) for the forms of ampoules in current use, and to disregard the letter A.

iv © ISO 2006 – All rights reserved

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INTERNATIONAL STANDARD ISO 9187-1:2006(E)

Injection equipment for medical use —
Part 1:
Ampoules for injectables
1 Scope
This part of ISO 9187 specifies materials, dimensions, capacities, performance and packaging requirements
for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products.
It 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 this part of ISO 9187 are intended f
...