ISO 9187-1:1991
(Main)Injection equipment for medical use — Part 1: Ampoules for injectables
Injection equipment for medical use — Part 1: Ampoules for injectables
Matériel d'injection à usage médical — Partie 1: Ampoules pour produits injectables
General Information
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Standards Content (Sample)
ISO
INTERNATIONAL
9187-1
STANDARD
First edition
1991-06-15
Injection equipment for medical use -
Part 1 :
Ampoules for injectables
Ma t&iel d’hjection 6 usage medical -
Partie 7 : Ampoules pour produits injectables
Reference number
ISO 9187-1 : 1991 (E)
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ISO 91874 : 1991 (E)
Contents
Page
1
. . .
1 Scope . . . . . . . . . . . . . . . . . .
1
. . .
2 Normative references . . = . . .
2
. . .
3 Dimensions and designation
4
4 Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
5 Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
6 Test for breaking forte . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
7 Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
8 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
9 Marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
0 ISO 1991
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International Organization for Standardization
Case postale 56 l CH-1211 Geneve 20 e Switzerland
Printed in Switzerland
ii
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ISO 9187-1 : 1991 (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. Esch 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, govern-
mental and non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission (1 EC) on all
matters of electrotechnical standardization.
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.
International Standard ISO 9187 was prepared by Technical Committee ISO/TC 76,
Transfusion, infusion and injection equipment for medical use.
of the following Parts under the general title lnjection equipmen t
ISO 9187 will consist
for medical use:
Part 7: Ampoules for injectables
-
Part 2: OPC-ampoules
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ISO 91874 : 1991 (EI
Introduction
Ampoules are suitable primary 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 ampoules (forms A, B, C and D) have, in the past, been in
widespread use; however, form A is no longer necessary for the pharmaceutical
industry and, consequently, has not been included in this International Standard. To
avoid any likelihood of confusion between manufacturers and users, it was decided to
retain the same designation letters (i.e. B, C and D) for the forms of ampoule in current
use and to disregard the letter A.
lt is known that different dimensions of ampoules exist at present in various countries
as Standard Versions. Many countries have already switched over to the dimensions
laid down in this part of ISO 9187. All other countries whose ampoules do not yet
comply with the dimensions laid down in this part of ISO 9187 should switch over
within a period of three years after publication.
IV
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ISO 9187-1 : 1991 (E)
INTERNATIONAL STANDARD
Injection equipment for medical use - Ampoules
for injectables
ISO 9187. At the time of publication, the editions indicated
1 Scope
were valid. All Standards are subject to revision, and Parties to
agreements based on this part of ISO 9187 are encouraged to
This part of ISO 9187 specifies materials, dimensions and
capacities, and performante and packaging requirements for investigate the possibility of applying the most recent editions
of the Standards listed below. Members of IEC and ISO main-
three forms of glass ampoules (forms B, C and D) for injec-
tables. tain registers of currently valid International Standards.
lt applies to ampoules with and without a colour break ring.
ISO 720 : 1985, Glass - Hydrolytic resistance of glass grains at
Me thod of test and classification.
121 OC -
If ampoules with colour break ring are requested by the User,
this should be agreed between manufacturer and User, in-
1989, Sampling procedures for inspection b y
ISO 2859-1 :
cluding a decision on break ring colour.
a ttributes - Part 7: Sampling Plans indexed b y accep table
quality level (AQL) for lot-by-lot inspection.
Ampoules complying with this part of ISO 9187 are intended for
Single use only.
ISO 4802-1 : 1988, Glassware - Hydrolytic resistance of the in-
terior surfaces of glass Containers - Part 7: Determination by
titra tion me thod and classifica tion.
2 Normative references
The following Standards contain provisions which, through IS 0 7500- 1 : 1986, ll4e tallic ma terials - Verifica tion of s ta tic
uniaxial testing machines - Part 7 : Tensile testing machines.
reference in this text, constitute provisions of this part of
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ISO 9187-1 : 1991 (E)
3 Dimensions and designation
3.1 Dimensions
The dimensions of ampoules shall be as shown in figures 1, 2 and 3 (forms B, C and D respectively) and as given in table 1.
d6
Funnel-,
NOTE - For other dimen- NOTE - For other dimen-
sions, see figure 1. sions, see figure 1 .
Figure 1 - Form B: Figure 2 - Form C: Figure 3 - Form D:
Stern, Stern, Stern,
tut ampoule open-funnel ampoule sealed ampoule
with constriction
with constriction wit
...
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