Injection containers and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials (ISO 8362-6:2010)

ISO 8362‑6:2010 specifies caps made of aluminium-plastics combinations for injection vials as specified in ISO 8362‑1 and ISO 8362‑4.

Injektionsbehältnisse und Zubehör - Teil 6: Bördelkappen aus Aluminium-Kunststoffkombinationen für Injektionsflaschen (ISO 8362-6:2010)

Dieser Teil von ISO 8362 legt Bördelkappen aus Aluminium-Kunststoffkombinationen für Injektionsflaschen nach ISO 8362-1 und ISO 8362-4 fest.

Récipients et accessoires pour produits injectables - Partie 6: Capsules pour flacons d'injection fabriquées en un mélange aluminium-plastique (ISO 8362-6:2010)

L'ISO 8362-6:2010 spécifie des capsules en combinaison aluminium‑plastique pour flacons d'injection tels que spécifiés dans l'ISO 8362‑1 et l'ISO 8362‑4.

Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 6. del: Pokrovček vsebnika, izdelan iz kombinacije aluminija in plastike, za viale (ISO 8362-6:2010)

Ta del ISO 8362 določa pokrovčke vsebnika, izdelane iz kombinacije aluminija in plastike, za viale, kot je določeno v ISO 8362-1 in ISO 8362-4.

General Information

Status
Published
Public Enquiry End Date
14-Dec-2010
Publication Date
16-Jun-2011
Technical Committee
VAZ - Healthcare
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
23-May-2011
Due Date
28-Jul-2011
Completion Date
17-Jun-2011

Overview

SIST EN ISO 8362-6:2011 is an international standard titled Injection containers and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials. Developed by ISO/TC 76 and adopted by CEN, this standard specifies requirements for aluminium-plastics combination caps designed specifically for injection vials referenced in ISO 8362-1 and ISO 8362-4. The standard ensures uniformity, safety, and reliability in caps used within the pharmaceutical and medical sectors, particularly for transfusion, infusion, and injection equipment.

The document emphasizes the caps' role as accessories rather than primary packaging, defining their dimensions, materials, mechanical requirements, and methods for quality control to guarantee compatibility with injection vials and compliance with regulatory demands.

Key Topics

  • Scope and Application
    Focuses on caps made from aluminium-plastics composites used with injection vials made of glass tubing or moulded glass as per ISO 8362 parts 1 and 4.

  • Classification of Caps
    Caps are categorized into:

    • Type ZB: Aluminium cap with a central opening and plastics component.
    • Type ZD: Aluminium cap with a full tear-off tab and plastics component.
  • Dimensions and Tolerances
    Detailed specifications for cap dimensions including diameter, thickness, and height are provided with precise tolerances following ISO 2768-1 and ISO 2768-2 standards for consistency and interchangeability.

  • Material and Construction Requirements
    Aluminium components must conform with ISO 8362-3 requirements, while plastics components and their integration with aluminium comply with ISO 10985. Construction must not interfere with vial sealing.

  • Mechanical Properties
    The standard defines the maximum forces allowed to remove the plastics component and tear-off tabs to ensure ease of use while maintaining security of the vial contents, with values varying by nominal cap size.

  • Packaging and Marking
    Packaging follows ISO 8872 requirements to maintain sterility and protection. Marking must clearly indicate the cap type, nominal size, and conform to ISO 8872 formatting.

Applications

This standard is crucial for manufacturers, suppliers, and quality assurance professionals in:

  • Pharmaceutical Packaging
    Ensuring injection vials are securely sealed during storage and transport, preventing contamination.

  • Medical Device Manufacturing
    Providing consistent and compatible caps for use in transfusion, infusion, and injection equipment.

  • Quality Control and Compliance
    Enabling testing against mechanical force parameters for tab removal and material standards to meet regulatory and health safety requirements.

  • Supply Chain Management
    Supporting clear designation and traceability of cap types, facilitating correct vial-cap matching in medical settings.

Related Standards

To fully comply with packaging and accessory requirements for injection containers, SIST EN ISO 8362-6:2011 should be used in conjunction with:

  • ISO 8362-1: Injection vials made of glass tubing
  • ISO 8362-3: Aluminium caps for injection vials
  • ISO 8362-4: Injection vials made of moulded glass
  • ISO 10985: Requirements for caps made of aluminium-plastics combinations
  • ISO 2768-1 & ISO 2768-2: General dimensional and geometrical tolerances
  • ISO 8872: General requirements and test methods for aluminium caps for infusion and injection bottles

By integrating SIST EN ISO 8362-6:2011 with these interconnected standards, manufacturers and users ensure optimal safety, functionality, and regulatory conformance in the production and administration of injectable pharmaceuticals.


Keywords: EN ISO 8362-6, injection vial caps, aluminium-plastics combination caps, injection container accessories, pharmaceutical packaging standards, medical vial sealing, injection vial closures, CEN standards, ISO injection vial caps, infusion equipment packaging.

Standard

SIST EN ISO 8362-6:2011

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Frequently Asked Questions

SIST EN ISO 8362-6:2011 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Injection containers and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials (ISO 8362-6:2010)". This standard covers: ISO 8362‑6:2010 specifies caps made of aluminium-plastics combinations for injection vials as specified in ISO 8362‑1 and ISO 8362‑4.

ISO 8362‑6:2010 specifies caps made of aluminium-plastics combinations for injection vials as specified in ISO 8362‑1 and ISO 8362‑4.

SIST EN ISO 8362-6:2011 is classified under the following ICS (International Classification for Standards) categories: 11.040.20 - Transfusion, infusion and injection equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

SIST EN ISO 8362-6:2011 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


SLOVENSKI STANDARD
01-julij-2011
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3RNURYþHNYVHEQLNDL]GHODQL]NRPELQDFLMHDOXPLQLMDLQSODVWLNH]DYLDOH ,62

Injection containers and accessories - Part 6: Caps made of aluminium-plastics
combinations for injection vials (ISO 8362-6:2010)
Injektionsbehältnisse und Zubehör - Teil 6: Bördelkappen aus Aluminium-
Kunststoffkombinationen für Injektionsflaschen (ISO 8362-6:2010)
Récipients et accessoires pour produits injectables - Partie 6: Capsules pour flacons
d'injection fabriquées en un mélange aluminium-plastique (ISO 8362-6:2010)
Ta slovenski standard je istoveten z: EN ISO 8362-6:2011
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 8362-6
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2011
ICS 11.040.20
English Version
Injection containers and accessories - Part 6: Caps made of
aluminium-plastics combinations for injection vials (ISO 8362-
6:2010)
Récipients et accessoires pour produits injectables - Partie Injektionsbehältnisse und Zubehör - Teil 6: Bördelkappen
6: Capsules pour flacons d'injection fabriquées en un aus Aluminium-Kunststoffkombinationen für
mélange aluminium-plastique (ISO 8362-6:2010) Injektionsflaschen (ISO 8362-6:2010)
This European Standard was approved by CEN on 24 March 2011.

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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8362-6:2011: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
The text of ISO 8362-6:2010 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion
and injection, and blood processing equipment for medical and pharmaceutical use” of the International
Organization for Standardization (ISO) and has been taken over as EN ISO 8362-6:2011 by 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 October 2011, and conflicting national standards shall be withdrawn at
the latest by October 2011.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 8362-6:2010 has been approved by CEN as a EN ISO 8362-6:2011 without any modification.

INTERNATIONAL ISO
STANDARD 8362-6
Second edition
2010-06-01
Injection containers and accessories —
Part 6:
Caps made of aluminium-plastics
combinations for injection vials
Récipients et accessoires pour produits injectables —
Partie 6: Capsules pour flacons d'injection fabriquées en un mélange
aluminium-plastique
Reference number
ISO 8362-6:2010(E)
©
ISO 2010
ISO 8362-6:2010(E)
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ISO 8362-6:2010(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodie
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