ISO 8362-2:2015 PDF

Scope: This part of ISO 8362 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 this part of ISO 8362 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.

ISO 8362-2:2015 Referenced Document

ISO 15378:2011 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
ISO 2230:2002 Rubber products - Guidelines for storage
ISO 3302-1:2014 Rubber - Tolerances for products - Part 1: Dimensional tolerances
ISO 3302-2:2008 Rubber - Tolerances for products - Part 2: Geometrical tolerances
ISO 48:2010 Rubber, vulcanized or thermoplastic - Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 7619-1:2010 Rubber, vulcanized or thermoplastic - Determination of indentation hardness - Part 1: Durometer method (Shore hardness)
ISO 8362-1:2009 Injection containers and accessories - Part 1: Injection vials made of glass tubing
ISO 8362-4:2011 Injection containers and accessories - Part 4: Injection vials made of moulded glass
ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates
ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods
ISO 8871-5:2005 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing

2024 ISO 8362-2:2024 Injection containers and accessories
2022 ISO 8362-2:2015/Amd 1:2022 Injection containers and accessories — Part 2: Closures for injection vials — Amendment 1
2015 ISO 8362-2:2015 Injection containers and accessories - Part 2: Closures for injection vials
2008 ISO 8362-2:2008 Injection containers and accessories - Part 2: Closures for injection vials
1988 ISO 8362-2:1988 Injection containers for injectables and accessories; part 2: closures for injection vials