EN 28362-2 : 1993
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
INJECTION CONTAINERS FOR INJECTABLES AND ACCESSORIES - CLOSURES FOR INJECTION VIALS
01-09-2010
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Superseded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 |
| Standards | Relationship |
| PN EN 28362-2 : 2002 | Identical |
| NS ISO 8362-2 : 1ED 1993 | Identical |
| NBN EN 28362-2 : 1993 | Identical |
| NEN ISO 8362-2 : 2008 | Identical |
| NF EN 28362-2 : 1993 | Identical |
| ISO 8362-2:2015 | Identical |
| BS EN 28362-2:1993 | Identical |
| UNE-EN 28362-2:1994 | Identical |
| UNI EN 28362-2 : 1993 | Identical |
| SNV NF EN 28362-2 : 1993 | Identical |
| I.S. EN 28362-2:1994 | Identical |
| SNV DIN ISO 8362-2 : 1989 | Identical |
| DIN ISO 8362-2:1989-12 | Identical |
| DIN ISO 8362-2:1989-12 | Corresponds |
| 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 (ISO 8871-1:2003) |
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