SIST EN ISO 9187-1:2003

SLOVENSKI STANDARD
01-september-2003
1DGRPHãþD
SIST EN ISO 9187-1:2000
SIST EN ISO 9187-1:2000/AC:2000
Oprema za injiciranje za uporabo v medicini - 1. del: Ampule za paranteralne
farmacevtske oblike (ISO 9187-1:2000)
Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2000)
Infusionsgeräte zur medizinischen Verwendung - Teil 1: Ampullen für Injektionspräparate
(ISO 9187-1:2000)
Matériel d'injection a usage médical - Partie 1: Ampoules pour produits injectables (ISO
9187-1:2000)
Ta slovenski standard je istoveten z: EN ISO 9187-1:2003
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 9187-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2003
ICS 11.040.20 Supersedes EN ISO 9187-1:1999
English version
Injection equipment for medical use - Part 1: Ampoules for
injectables (ISO 9187-1:2000)
Matériel d'injection à usage médical - Partie 1: Ampoules Infusionsgeräte zur medizinischen Verwendung - Teil 1:
pour produits injectables (ISO 9187-1:2000) Ampullen für Injektionspräparate (ISO 9187-1:2000)
This European Standard was approved by CEN on 27 December 2002.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, 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
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9187-1:2003 E
worldwide for CEN national Members.

Foreword
The text of ISO 9187-1:2000 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-
1:2003 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 November 2003, and conflicting national
standards shall be withdrawn at the latest by November 2003.
This document supersedes EN ISO 9187-1:1999.
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, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 9187-1:2000 has been approved by CEN as EN ISO 9187-1:2003 without any
modifications.
NOTE Normative references to International Standards are listed in annex ZB (normative).
Annex ZA
(informative)
A-deviations
A-deviation: National deviation due to regulations, the alteration of which is for the time being
outside the competence of CEN/CENELEC member:
NOTE: Where standards fall under EC Directives it is the view of the Commission of the
European Communities (OJ No G 59, 9.3, 1982) that the effect of the decision of the Court of
Justice in case 815/79 Cremonini/Vrankovitch (European Court Reports 1980, p.3583) is that
compliance with A-deviations is no longer mandatory and that the free movement of products
complying with such a standard should not be restricted except under the safeguard procedure
provided for in the relevant Directive.
A-deviations in an EFTA country are valid instead of the relevant provisions of the European
Standard in that country until they have been removed.
The European Standard is not in agreement with the European Pharmacopoeia 2nd edition
VI.2.3.1, which is mandatory in Sweden, by LVFS 1996:16.
Annex ZB
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 7500-1 1999 Metallic materials - Verification of static EN ISO 7500-1 1999
uniaxial testing machines - Part 1:
Tension/compression testing machines
INTERNATIONAL ISO
STANDARD 9187-1
Second edition
2000-05-01
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 9187-1:2000(E)
©
ISO 2000
ISO 9187-1:2000(E)
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ii © ISO 2000 – All rights reserved

ISO 9187-1:2000(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Normative references .1
3 Dimensions and designation.2
4 Material .2
5 Requirements.2
6 Test for breaking force.5
7 Delivery.7
8 Packaging.7
9 Marking .7
ISO 9187-1:2000(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 3.
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 part of ISO 9187 may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 9187-1 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and
injection equipment for medical and pharmaceutical use.
This second edition cancels and replaces the first edition (ISO 9187-1:1991), which has been technically revised.
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
iv © ISO 2000 – All rights reserved

ISO 9187-1:2000(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 must be 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.
Four standardized forms of ampoule (forms A, B, C and D) have, in the past, 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.
INTERNATIONAL STANDARD ISO 9187-1:2000(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 applies to ampoules with or without a colour break-ring.
If ampoules with a colour break-ring are requested by the user, this should be agreed between manufacturer and
user, including a decision on break-ring colour.
Ampoules complying with this part of ISO 9187 are intended for single use only.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this part of ISO 9187. For dated references, subsequent amendments to, or revisions of, any of these publications
do not apply. However, parties to agreements based on this part of ISO 9187 are encouraged to investigate the
possibility of applying the most recent editions of the normative documents indicated below. For undated
references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain
registers of currently valid International Standards.
ISO 720:1985, Glass — Hydrolytic resistance of glass grains at 121 °C — Method of test and classification.
1)
ISO 1101:— , Geometrical product specifications (GPS) — Geometrical tolerancing — Tolerances of form,
orientation, location and run-out.
ISO 2859-1:1999, Sampling procedures for inspection by attribute — Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection.
ISO 4802-1:1988, Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1:
Determination by titration method and classification.
ISO 4802-2:1988, Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2:
Determination by flame spectrometry and classification.
ISO 7500-1:1999, Metallic materials — Verification of static uniaxial testing machine — Part 1: Tension/compression
testing machine — Verification and calibration of the force-measuring system.
1) To be published. (Revision of ISO 1101:1983)
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