EN ISO 8362-2:2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015)
30-04-2016
28-10-2015
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Classification
4 Shape and dimensions
5 Designation
6 Material
7 Performance requirements
8 Labelling
Bibliography
ISO 8362-2:2015 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362‑1 and ISO 8362‑4.The dimensional requirements are not applicable to barrier-coated closures.Closures specified in ISO 8362-2:2015 are intended for single use only.
| Committee |
CEN/BT
|
| DevelopmentNote |
Supersedes EN 28362-2. (09/2010)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 8362-2 : 2016 | Identical |
| DS EN ISO 8362-2 : 2015 | Identical |
| UNI EN ISO 8362-2:2022 | Identical |
| UNE-EN ISO 8362-2:2015 | Identical |
| BS EN ISO 8362-2:2015 | Identical |
| ISO 8362-2:2015 | Identical |
| DIN EN ISO 8362-2:2016-02 | Identical |
| NS EN ISO 8362-2 : 2010 | Identical |
| NF EN ISO 8362-2 : 2015 | Identical |
| PN EN ISO 8362-2 : 2016 | Identical |
| NBN EN ISO 8362-2 : 2010 | Identical |
| SN EN ISO 8362-2 : 2016 | Identical |
| I.S. EN ISO 8362-2:2015 | Identical |
| UNI EN ISO 8362-2:2015 | Identical |
| NEN EN ISO 8362-2 : 2015 | Identical |
| UNI EN ISO 8362-2 : 2010 | Identical |
| ISO 8871-1:2003 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates |
| ISO 7619-1:2010 | Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness) |
| ISO 2230:2002 | Rubber products — Guidelines for storage |
| ISO 8362-4:2011 | Injection containers and accessories Part 4: Injection vials made of moulded glass |
| ISO 3302-1:2014 | Rubber — Tolerances for products — Part 1: Dimensional tolerances |
| ISO 15378:2017 | Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
| ISO 8362-1:2009 | Injection containers and accessories Part 1: Injection vials made of glass tubing |
| ISO 3302-2:2008 | Rubber Tolerances for products Part 2: Geometrical tolerances |
| ISO 8871-5:2016 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing |
| ISO 48:2010 | Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD) |
| ISO 8871-4:2006 | Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods |
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