EN ISO 8536-2:2023

Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2023)

This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.
NOTE       The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

Infusionsgeräte zur medizinischen Verwendung - Teil 2: Stopfen für Infusionsflaschen (ISO 8536-2:2023)

Dieses Dokument legt die Form, die Maße, den Werkstoff, die Leistungsanforderungen und die Kennzeichnung von Stopfen für Infusionsflaschen nach ISO8536-1 fest.
Die Anforderungen an die Maße sind nicht anzuwenden für beschichtete Stopfen.
Stopfen nach diesem Dokument 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.

Matériel de perfusion à usage médical - Partie 2: Bouchons pour flacons de perfusion (ISO 8536-2:2023)

Le présent document spécifie la forme, les dimensions, le matériau, les exigences de performance et l'étiquetage des bouchons pour flacons de perfusion spécifiés dans l'ISO 8536-1.
Les exigences dimensionnelles ne s'appliquent pas aux bouchons avec revêtement protecteur.
Les bouchons faisant l'objet du présent document sont à usage unique.
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.

Infuzijska oprema za uporabo v medicini - 2. del: Zapirala za infuzijske steklenice (ISO 8536-2:2023)

Ta dokument določa obliko, dimenzije, material, delovne zahteve in etiketiranje zapiral za infuzijske steklenice, kot je določeno v standard ISO 8536-1.
Zahteve glede dimenzij ne veljajo za zapirala s pregrado.
Zapirala, ki jih določa ta dokument, so namenjena le za enkratno uporabo.
OPOMBA:       Na jakost, čistost, stabilnost in varnost zdravila med proizvodnjo in skladiščenjem lahko močno vplivata tip in zmogljivost primarne embalaže.

General Information

• Status: Published
• Publication Date: 14-Feb-2023
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/SS S02 - Transfusion equipment
• Drafting Committee: CEN/SS S02 - Transfusion equipment
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 15-Feb-2023
• Completion Date: 15-Feb-2023
• Ref Project: SIST EN ISO 8536-2:2023 - Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2023)

Relations

• Replaces: EN ISO 8536-2:2010 - Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8536-2:2023
01-maj-2023
Nadomešča:
SIST EN ISO 8536-2:2010
Infuzijska oprema za uporabo v medicini - 2. del: Zapirala za infuzijske steklenice
(ISO 8536-2:2023)
Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-
2:2023)
Infusionsgeräte zur medizinischen Verwendung - Teil 2: Stopfen für Infusionsflaschen
(ISO 8536-2:2023)
Matériel de perfusion à usage médical - Partie 2: Bouchons pour flacons de perfusion
(ISO 8536-2:2023)
Ta slovenski standard je istoveten z: EN ISO 8536-2:2023
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8536-2:2023


EN ISO 8536-2
EUROPEAN STANDARD

NORME EUROPÉENNE

February 2023
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8536-2:2010
English Version

Infusion equipment for medical use - Part 2: Closures for
infusion bottles (ISO 8536-2:2023)
Matériel de perfusion à usage médical - Partie 2: Infusionsgeräte zur medizinischen Verwendung - Teil
Bouchons pour flacons de perfusion (ISO 8536-2:2023) 2: Stopfen für Infusionsflaschen (ISO 8536-2:2023)
This European Standard was approved by CEN on 17 June 2022.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-2:2023 E
worldwide for CEN national Members.

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SIST EN ISO 8536-2:2023
EN ISO 8536-2:2023 (E)
Contents Page
European foreword . 3

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EN ISO 8536-2:2023 (E)
European foreword
This document (EN ISO 8536-2:2023) 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 CCMC.
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 2023, and conflicting national standards shall
be withdrawn at the latest by August 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8536-2:2010.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 8536-2:2023 has been approved by CEN as EN ISO 8536-2:2023 without any
modification.


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