SIST EN 28872:2000

SLOVENSKI STANDARD
SIST EN 28872:2000
01-januar-2000
Aluminijeve zaporke za transfuzijske, infuzijske in injekcijske steklenice - Splošne
zahteve in preskusne metode (ISO 8872:1988)
Aluminium caps for transfusion, infusion and injection bottles - General requirements and
test methods (ISO 8872:1988)
Aluminium-Bördelkappen für Transfusions-, Infusions- und Injektionsflaschen -
Allgemeine Anforderungen und Prüfverfahren (ISO 8872:1988)
Capsules en aluminium pour flacons de transfusion, perfusion et injection -
Spécifications générales et méthodes d'essai (ISO 8872:1988)
Ta slovenski standard je istoveten z: EN 28872:1993
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN 28872:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 28872:2000

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SIST EN 28872:2000

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SIST EN 28872:2000

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SIST EN 28872:2000
IS0
INTERNATIONAL STANDARD
8872
First edition
1988-12-15
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
ORGANISATION INTERNATIONALE DE NORMALISATION
MEX)JYHAPOaHAR OPTAHM3A~MR l-l0 CTAH~APTM3ALJMM
Aluminium caps for transfusion, infusion and injection
General requirements and test methods
bottles -
Capsules en aluminium pour flacons de transfusion, perfusion et injection - Spkifications
g&&ales et mbthodes d’essai
Reference number
IS0 8872 : 1988 (E)

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SIST EN 28872:2000
IS0 8872 : 1988 (El
Page
Contents
Foreword. iii
lntroduction. iv
1
Scope .
1
Normative references .
1
Requirements .
2
Testmethods .
3
Cleaning, sterilization and coating .
4
...........................................................
Packaging
4
Marking .
5
Annex A : Example of chemical composition of wrought product . . . . . . . . . . . . . . .
@ International Organization for Standardization, 1988 l
Printed in Switzerland

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SIST EN 28872:2000
IS0 8872 : 1988 (El
Foreword
IS0 (the International Organization for Standardization) is a worldwide federation of
national standards bodies (IS0 member bodies). The work of preparing International
Standards is normally carried out through IS0 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, govern-
mental and non-governmental, in liaison with ISO, also take part in the work. IS0
collaborates closely with the International Electrotechnical Commission (IEC) on all
matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are circulated to
the member bodies for approval before their acceptance as International Standards by
the IS0 Council. They are approved in accordance with IS0 procedures requiring at
least 75 % approval by the member bodies voting.
International Standard IS0 8872 was prepared by Technical Committee ISO/TC 76,
Transfusion, infusion and injection equipment for medical use.
Annex A of this International Standard is for information only.

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SIST EN 28872:2000
IS0 8872 : 1988 (El
Introduction
This International Standard specifies requirements in general for aluminium caps for
vials and bottles in the field of transfusion, infusion and injection. The primary
materials from which containers, including their elastomeric closures, are made have to
be suitable for the storage of such products until the products are administered.
However, in this International Standard, aluminium caps are not considered as primary
packaging materials that will come into direct contact with pharmaceutical prep-
arations or blood.
I
iv

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SIST EN 28872:2000
INTERNATIONAL STANDARD IS0 8872 : 1988 (E)
Aluminium caps for transfusion, infusion and injection
bottles - General requirements and test methods
3.1.2 Chemical composition
1 Scope
The wrought (sheet and strip) used for the manufacture of caps
This International Standard specifies general requirements and
test methods for aluminium caps for injection vials, and in- shall be produced from aluminium alloy.
fusion and transfusion bottles.
NOTE - The chemical composition of widely used aluminium alloys is
given as an example in annex A.
2 Normative references
The chemical composition shall be checked in accordance with
The following standards contain provisions which, through 4.3.
reference in this text, constitute provisions of this International
Standard. At the time of publication, the editions indicated
3.2 Caps
were valid. All standards are subject to revision, and parties to
agreements based on this International Standard are encouraged
to investigate the possibility of applying the most recent
3.2.1 Dimensions
editions of the standards listed below. Members of IEC and IS0
maintain registers of currently valid International Standards. Aluminium caps shall comply with the dimensions and with the
accepted tolerances as specified in the pertinent International
IS 0 6892 : 1984, Metallic materials - Tensile testing .
Standards.
IS0 7500-l : 1986, Metallic materials - Verification of static
The thickness shall be measured in accordance with 4.4.
uniaxial testing machines - Fart 7: Tensl’le testing machines.
3.2.2 Contamination
3 Requirements
Aluminium caps shall be free from contamination; the presence
of residual lubricants and burrs shall be avoided.
3.1 Wrought products
3.2.3 Earing
3.1 .I Mechanical characteristics
Aluminium caps should be free from earing defects at the
The mechanical characteristics shall comply with the
requirements specified for the three grades A, B and C (see cutting processing edge. If earing occurs, the earing defect,
table 1) and shall be tested in accordance with the test as measured in accordance with 4.5, shall not be greater
procedures described in 4.2. than 3 %.
3.2.4 Crimping
Table 1 - Grades of mechanical characteristics
Aluminium caps shall fit properly when subjected to the crimp-
Proof stress of
non-proportional ing process as described in 4.6.
Tensile strength
elongation
Grade Alloy 1)
Rrn
RP
3.2.5 Resistance of caps
N/mm2 N/mm2
min.
min. max.
3.2.5.1 When tested in accordance with 5.2, the aluminium
Al Fe Si
caps, put in place by a crimping process as described in 4.6,
annealed
A 100 150 80
or coated
shall not show ruptures or important signs of deformation.
130 170 110
B Al Fe Si
NOTE - This requirement only applies to caps that will be subject to
C Al Mn Cu 140 180 120
sterilization.
1) These alloys present a selection of widely used aluminium
alloys for manufacture of caps. Other alloys are permitted,
3.2.5
...