EN ISO 8362-7:2010

Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8362-7:2006)

ISO 8362-7:2006 specifies aluminium-plastics combinations for the injection caps of injection vials, as specified in ISO 8362-1 and ISO 8362-4, where the plastics part does not overlap the diameter of the vial body.

Injektionsbehältnisse und Zubehör - Teil 7: Bördelkappen aus Aluminium-Kunststoffkombinationen für Injektionsflaschen ohne überstehendes Kunststoffteil (ISO 8362-7:2006)

Dieser Teil von ISO 8362 legt Aluminium-Kunstoffkombinationen für Bördelkappen für Injektionsflaschen nach ISO 8362 1 und ISO 8362-4 fest, deren Kunststoffteil den Durchmesser des Flaschenkörpers nicht überragt.

Récipients et accessoires pour produits injectables - Partie 7: Capsules d'injection en combinaison aluminium-plastique avec élément plastique non débordant (ISO 8362-7:2006)

L'ISO 8362-7:2006 spécifie des capsules d'injection en combinaison aluminium-plastique pour flacons d'injection tels que spécifiés dans l'ISO 8362-1 et l'ISO 8362-4, où les éléments en plastique ne dépassent pas le diamètre du corps du flacon.

Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 7. del: Pokrovček iz plastificiranega aluminija brez prekrivanja s plastičnim delom (ISO 8362-7:2006)

Ta del ISO 8362 določa pokrovčke iz plastificiranega aluminija za viale, kot je določeno v ISO 8362-1 in ISO 8362-4, kjer plastični deli ne prekrivajo premera glavnega dela vial.

General Information

• Status: Published
• Publication Date: 07-Dec-2010
• Withdrawal Date: 29-Jun-2011
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.25 - Syringes, needles an catheters
• 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: 08-Dec-2010
• Due Date: 18-Jan-2010
• Completion Date: 08-Dec-2010
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 8362-7:2011 - Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8362-7:2006)

Overview

EN ISO 8362-7:2010 is an international standard specifying requirements for injection caps made of aluminium-plastics combinations used in injection vials. This part of the ISO 8362 series focuses specifically on injection caps where the plastics component does not overlap the diameter of the vial body, ensuring compatibility with automated vial processing systems. Published by CEN and derived from ISO 8362-7:2006, the standard supports manufacturing consistency and safety in pharmaceutical packaging, particularly for transfusion, infusion, and injection equipment.

The standard applies to injection vials covered under ISO 8362-1 and ISO 8362-4 and aims to address challenges encountered during vial labeling and storage when overlapping plastics may cause process disruptions.

Key Topics

• Scope and Application
  Specifies aluminium-plastics caps designed for injection vials with a non-overlapping plastics part, suited to prevent mechanical interference in automated processing.

• Classification of Cap Types

  • Type OB: Aluminium cap with a central opening, without overlapping plastics
  • Type OD: Aluminium cap with a complete tear-off tab, without overlapping plastics

• Dimensions and Tolerances
  Detailed dimensional specifications and tolerances aligned with ISO 2768-1 and ISO 2768-2 ensure standardization in cap sizing for nominal vial sizes (e.g., 13 mm and 20 mm).

• Force Requirements
  Defines the force range for removing the plastics component and tearing off tabs, tested with calibrated devices (ISO 7500-1 compliant), critical for quality control and user safety.

• Packaging and Marking
  Caps must be packaged according to ISO 8872 requirements and marked with standardized designations, facilitating traceability and regulatory compliance.

Applications

EN ISO 8362-7:2010 is primarily used in the medical and pharmaceutical industries for:

• Primary Packaging of Injectable Drugs
  While injection caps themselves aren't direct-contact primary packaging, they are integral to securing injection vials, maintaining sterility and integrity.

• Automated Manufacturing and Labeling Lines
  By preventing plastics from overlapping vial diameters, the caps optimize compatibility with automated vial labeling, storage, and handling equipment.

• Transfusion, Infusion, and Injection Equipment
  Ensures standard interface components for medical injection devices, contributing to patient safety and equipment reliability.

• Quality Control and Compliance
  Manufacturers use the standard for product specification, incoming inspection, and to meet international regulatory requirements for medical devices.

Related Standards

• 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 8362-6: Caps made of aluminium-plastics combinations with overlapping plastics part
• ISO 8872: Aluminium caps for transfusion, infusion, and injection bottles – general requirements and test methods
• ISO 2768-1 / ISO 2768-2: General tolerances for linear, angular, and geometrical dimensions
• ISO 7500-1: Verification and calibration of static uniaxial testing machines

By adhering to EN ISO 8362-7:2010, manufacturers and healthcare providers ensure the production and use of reliable, dimensionally consistent, and safe aluminium-plastics injection caps suitable for critical medical applications.

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Keywords: injection caps, aluminium-plastics combinations, ISO 8362-7, injection vials, pharmaceutical packaging, medical device standards, non-overlapping plastics, vial caps, transfusion equipment, infusion equipment, pharmaceutical vial closure, medical packaging standards, CEN medical standards.

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2011
9VHEQLNL]DSDUHQWHUDOQHIDUPDFHYWVNHREOLNHLQGRGDWQDRSUHPDGHO
3RNURYþHNL]SODVWLILFLUDQHJDDOXPLQLMDEUH]SUHNULYDQMDVSODVWLþQLPGHORP,62

Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics
combinations without overlapping plastics part (ISO 8362-7:2006)
Injektionsbehältnisse und Zubehör - Teil 7: Bördelkappen aus Aluminium-
Kunststoffkombinationen für Injektionsflaschen ohne überstehendes Kunststoffteil (ISO
8362-7:2006)
Récipients et accessoires pour produits injectables - Partie 7: Capsules d'injection en
combinaison aluminium-plastique avec élément plastique non débordant (ISO 8362-
7:2006)
Ta slovenski standard je istoveten z: EN ISO 8362-7:2010
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 8362-7
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2010
ICS 11.040.20
English Version
Injection containers and accessories - Part 7: Injection caps
made of aluminium-plastics combinations without overlapping
plastics part (ISO 8362-7:2006)
Récipients et accessoires pour produits injectables - Partie Injektionsbehältnisse und Zubehör - Teil 7: Bördelkappen
7: Capsules d'injection en combinaison aluminium- aus Aluminium-Kunststoffkombinationen für
plastique avec élément plastique non débordant (ISO 8362- Injektionsflaschen ohne überstehendes Kunststoffteil (ISO
7:2006) 8362-7:2006)
This European Standard was approved by CEN on 21 November 2010.

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
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8362-7:2010: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
The text of ISO 8362-7:2006 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 8362-7:2010 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 June 2011, and conflicting national standards shall be withdrawn at
the latest by June 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 8362-7:2006 has been approved by CEN as a EN ISO 8362-7:2010 without any modification.

INTERNATIONAL ISO
STANDARD 8362-7
Second edition
2006-04-15
Injection containers and accessories —
Part 7:
Injection caps made of aluminium-
plastics combinations without
overlapping plastics part
Récipients et accessoires pour produits injectables —
Partie 7: Capsules d'injection en combinaison aluminium-plastique avec
élément plastique non débordant

Reference number
ISO 8362-7:2006(E)
©
ISO 2006
ISO 8362-7:2006(E)
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ISO 8362-7:2006(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
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, governmental and
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The main task of technical committees is to prepare International Standards. Draft International Standards
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International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible
...