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BS EN ISO 8362-2:2015

Current
Current

The latest, up-to-date edition.

Injection containers and accessories Closures for injection vials
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-10-2015

This part of ISO8362 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO8362-1 and ISO8362-4.

The dimensional requirements are not applicable to barrier-coated closures.

Closures specified in this part of ISO8362 are intended for single use only.

NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

Committee
CH/212
DevelopmentNote
Supersedes BS EN 28362-2. (09/2010) Supersedes 14/30301958 DC. (11/2015)
DocumentType
Standard
Pages
18
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
ISO 8362-2:2015 Identical
EN ISO 8362-2:2015 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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