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EN 28362-2 : 1993

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

INJECTION CONTAINERS FOR INJECTABLES AND ACCESSORIES - CLOSURES FOR INJECTION VIALS

Superseded date

01-09-2010

Published date

12-01-2013

Cooperating organizations
National foreword
Foreword
Specification
Introduction
1. Scope
2. Normative references
3. Dimensions and designation
4. Material
5. Requirements
6. Sample
7. Marking
Annexes
A. (normative) Test method for fragmentation
B. (normative) Test method for penetrability
C. (normative) Test method for closure/container
     integrity and self-sealing
ZA. (normative) Normative references to international
     publications with their relevant European
     publications
Tables
1. Dimensions of injection closures
2. Chemical limits for injection closures
A.1 Dimensions of bevel
Figures
1. Dimensions and configuration of types A and B
     closures
A.1 Needle point
A.2 Test sequence for fragmentation test
B.1 Schematic representation of device for testing
     penetrability
National annexes
NA (informative) Committees responsible
NB (informative) Cross-references

Specifies the dimensions, design, performance, material, requirements and tests for closures for injection vials. Deals with closures that are meant for single use only. Also includes annexes, tables and diagrams.

Committee
CEN/TC 205
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

BS EN ISO 8871-1:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use Extractables in aqueous autoclavates
ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
EN ISO 8871-1 : 2004 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES

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