SIST EN ISO 8362-3:2003

Injection containers and accessories - Part 3: Aluminium caps for injection vials (ISO 8362-3:2001)

This part of ISO 8362 specifies aluminium caps for injection vials as described in ISO 8362-1 and ISO 8362-4.

Injektionsbehältnisse für Injektionspräparate und Zubehör - Teil 3: Aluminium-Bördelkappen für Injektionsflaschen (ISO 8362-3:2001)

Diese Internationale Norm legt Aluminium-Bördelkappen für Injektionsflaschen, wie in ISO 8362-1 und ISO 8362-4 beschrieben, fest.

Récipients et accessoires pour produits injectables - Partie 3: Capsules en aluminium pour flacons (ISO 8362-3:2001)

La présente partie de l'ISO 8362 fixe les spécifications des capsules en aluminium pour flacons de produits
injectables tels que décrits dans l'ISO 8362-1 et l'ISO 8362-4.

Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 3. del: Aluminijeve zaporke za viale (ISO 8362-3:2001)

General Information

• Status: Published
• Publication Date: 31-Aug-2003
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Sep-2003
• Due Date: 01-Sep-2003
• Completion Date: 01-Sep-2003
• Ref Project: EN ISO 8362-3:2003 - Injection containers and accessories - Part 3: Aluminium caps for injection vials (ISO 8362-3:2001)

Relations

• Replaces: SIST EN 28362-3:2000 - Injection containers for injectables and accessories - Part 3: Aluminium caps for injection vials (ISO 8362-3:1989)
• Effective Date: 01-Sep-2003

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8362-3:2003
01-september-2003
1DGRPHãþD
SIST EN 28362-3:2000
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 3. del:
Aluminijeve zaporke za viale (ISO 8362-3:2001)
Injection containers and accessories - Part 3: Aluminium caps for injection vials (ISO
8362-3:2001)
Injektionsbehältnisse für Injektionspräparate und Zubehör - Teil 3: Aluminium-
Bördelkappen für Injektionsflaschen (ISO 8362-3:2001)
Récipients et accessoires pour produits injectables - Partie 3: Capsules en aluminium
pour flacons (ISO 8362-3:2001)
Ta slovenski standard je istoveten z: EN ISO 8362-3:2003
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8362-3:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8362-3:2003

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SIST EN ISO 8362-3:2003
EUROPEAN STANDARD
EN ISO 8362-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2003
ICS 11.040.20 Supersedes EN 28362-3:1993
English version
Injection containers and accessories - Part 3: Aluminium caps
for injection vials (ISO 8362-3:2001)
Récipients et accessoires pour produits injectables - Partie Injektionsbehältnisse für Injektionspräparate und Zubehör -
3: Capsules en aluminium pour flacons (ISO 8362-3:2001) Teil 3: Aluminium-Bördelkappen für Injektionsflaschen (ISO
8362-3:2001)
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 8362-3:2003 E
worldwide for CEN national Members.

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SIST EN ISO 8362-3:2003
EN ISO 8362-3:2003 (E)
CORRECTED  2003-03-26
Foreword
The text of ISO 8362-3:2001 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 8362-
3:2003 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 August 2003, and conflicting national
standards shall be withdrawn at the latest by August 2003.
This document supersedes EN 28362-3:1993.
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 8362-3:2001 has been approved by CEN as EN ISO 8362-3:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
2

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SIST EN ISO 8362-3:2003
EN ISO 8362-3:2003 (E)
Annex ZA
(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 8872 1988 Aluminium caps for transfusion, infusion EN 28872 1993
and injection bottles - General
requirements and test methods
3

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SIST EN ISO 8362-3:2003

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SIST EN ISO 8362-3:2003
INTERNATIONAL ISO
STANDARD 8362-3
Second edition
2001-12-01
Injection containers and accessories —
Part 3:
Aluminium caps for injection vials
Récipients et accessoires pour produits injectables —
Partie 3: Capsules en aluminium pour flacons
Reference number
ISO 8362-3:2001(E)
© ISO 2001

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SIST EN ISO 8362-3:2003
ISO 8362-3:2001(E)
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SIST EN ISO 8362-3:2003
ISO 8362-3:2001(E)
Contents Page
1 Scope . 1
2 Normative reference . 1
3 Dimensions and designation .
...