EN ISO 8362-5:2016

Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)

ISO 8362-5:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362‑1 and ISO 8362‑4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this part of ISO 8362 are intended for single use only.
NOTE          The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.

Injektionsbehältnisse und Zubehör - Teil 5: Gefriertrocknungsstopfen für Injektionsflaschen (ISO 8362-5:2016)

Dieser Teil von ISO 8362 legt die Form, Maße, Werkstoffe, Leistungsanforderungen und Kennzeichnung für eine Stopfenart für Injektionsflaschen nach ISO 8362-1 und ISO 8362-4 fest, die in Verbindung mit der Gefriertrocknung (oder Lyophilisierung) von Arzneimitteln und biologischen Präparaten verwendet wird.
Die maßlichen Anforderungen sind nicht auf beschichtete Stopfen anwendbar.
Die in diesem Teil von ISO 8362 beschriebenen Stopfen sind nur zum einmaligen Gebrauch bestimmt.
ANMERKUNG   Die Wirksamkeit, Reinheit, Beständigkeit und Sicherheit eines Arzneimittels während seiner Herstellung und Lagerung können erheblich durch die Art und Ausführung des Primärpackmittels beeinträchtigt werden.

Récipients et accessoires pour produits injectables - Partie 5: Bouchons à lyophilisation pour flacons d'injection (ISO 8362-5:2016)

L'ISO 8362-5:2016 fixe la forme, les dimensions, le matériau, les exigences de performance et l'étiquetage des bouchons pour flacons d'injection, tels que décrits dans l'ISO 8632‑1 et l'ISO 8362‑4, utilisés pour les médicaments et les produits biologiques à lyophiliser.
Les exigences dimensionnelles ne s'appliquent pas aux bouchons avec revêtement protecteur.
Les bouchons faisant l'objet de la présente partie de l'ISO 8362-5:2016 sont à usage unique seulement.
NOTE          La nature et les performances de l'emballage primaire peuvent influer considérablement sur l'efficacité, la pureté, la stabilité et la sécurité d'un produit pharmaceutique au cours de sa fabrication et de son stockage.

Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 5. del: Pokrovčki za liofiziranje za injekcijske viale (ISO 8362-5:2016)

Ta del standarda EN ISO 8362 določa obliko, dimenzije, material, zahteve za delovanje in označevanje za vrsto pokrovčka za injekcijske viale, kot je opisano v standardih ISO 8362-1 in ISO 8362-4, ki se uporablja v zvezi s sušenjem z zamrzovanjem (ali liofilizacija) zdravil in bioloških materialov. Zahteve glede dimenzij ne veljajo za pokrovčke s pregrado.  Pokrovčki, ki jih določa ta del standarda ISO 8362, so namenjeni le enkratni uporabi.

General Information

• Status: Published
• Publication Date: 15-Mar-2016
• Withdrawal Date: 29-Sep-2016
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 16-Mar-2016
• Due Date: 24-Feb-2017
• Completion Date: 16-Mar-2016
• Ref Project: SIST EN ISO 8362-5:2016 - Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8362-5:2016
01-maj-2016
9VHEQLNL]DSDUHQWHUDOQHIDUPDFHYWVNHREOLNHLQGRGDWQDRSUHPDGHO
3RNURYþNL]DOLRIL]LUDQMH]DLQMHNFLMVNHYLDOH,62
Injection containers and accessories - Part 5: Freeze drying closures for injection vials
(ISO 8362-5:2016)
Injektionsbehältnisse und Zubehör - Teil 5: Gefriertrocknungsstopfen für
Injektionsflaschen (ISO 8362-5:2016)
Récipients et accessoires pour produits injectables - Partie 5: Bouchons à lyophilisation
pour flacons d'injection (ISO 8362-5:2016)
Ta slovenski standard je istoveten z: EN ISO 8362-5:2016
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8362-5:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8362-5:2016

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SIST EN ISO 8362-5:2016


EN ISO 8362-5
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2016
EUROPÄISCHE NORM
ICS 11.040.20
English Version

Injection containers and accessories - Part 5: Freeze drying
closures for injection vials (ISO 8362-5:2016)
Récipients et accessoires pour produits injectables - Injektionsbehältnisse und Zubehör - Teil 5:
Partie 5: Bouchons à lyophilisation pour flacons Gefriertrocknungsstopfen für Injektionsflaschen (ISO
d'injection (ISO 8362-5:2016) 8362-5:2016)
This European Standard was approved by CEN on 2 January 2016.

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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8362-5:2016 E
worldwide for CEN national Members.

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SIST EN ISO 8362-5:2016
EN ISO 8362-5:2016 (E)
Contents Page
European foreword . 3

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SIST EN ISO 8362-5:2016
EN ISO 8362-5:2016 (E)
European foreword
This document (EN ISO 8362-5:2016) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use" in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the
secretariat of which is held by DIN.
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 2016, and conflicting national standards
shall be withdrawn at the latest by September 2016.
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.
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, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 8362-5:2016 has been approved by CEN as EN ISO 8362-5:2016 without any
modification.
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SIST EN ISO 8362-5:2016

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SIST EN ISO
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