DIN ISO 8362-5:2011 PDF

Scope: This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this part of ISO 8362 are intended for single use only.

DIN ISO 8362-5:2011 Referenced Document

ISO 3302-1 Rubber - Tolerances for products - Part 1: Dimensional tolerances*， 2014-07-01 Update
ISO 3302-2 Rubber — Tolerances for products — Part 2: Geometrical tolerances*， 2022-05-23 Update
ISO 48 Rubber, vulcanized or thermoplastic - Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 8871-1 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates
ISO 8871-4 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

2016 DIN EN ISO 8362-5:2016 Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016); German version EN ISO 8362-5:2016
2011 DIN ISO 8362-5:2011 Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2008)
1970 DIN ISO 8362-5:1996-07 Injection containers and accessories - Part 5: Freeze drying closures for injection vials
0000 DIN ISO 8362-5:1996