This part of ISO 8362 specifies the shape, dimensions, materials, performance requirements and marking of stoppers for injection bottles according to ISO 8362-1 and ISO 8362-4. The dimensional requirements are not applicable to coated plugs; The plugs according to this part of ISO 8362 are for single use only. NOTE The effectiveness, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the type and design of the primary packaging.
EN ISO 8362-2:2015 Referenced Document
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
EN ISO 8362-2:2015 history
2022EN ISO 8362-2:2015/A1:2022 Injection containers and accessories - Part 2: Closures for injection vials - Amendment 1 (ISO 8362-2:2015/Amd 1:2022)
2015EN ISO 8362-2:2015 Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015)
2010EN ISO 8362-2:2010 Injection containers and accessories - Part 2: Closures for injection vials