Name: EN ISO 8362-2:2015
Brand: CEN

EN ISO 8362-2:2015

Withdrawn

Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015)

Amended by

EN ISO 8362-2:2015/A1:2022

Withdrawn date

04-30-2016

Published date

10-28-2015

Publisher

Comite Europeen de Normalisation

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Status	Withdrawn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	EN 28362-2 : 1993

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