BS EN ISO 8362-2:2015+A1:2022
Injection containers and accessories - Closures for injection vials
- Standard No.
- BS EN ISO 8362-2:2015+A1:2022
- Release Date
- 2022
- Published By
- British Standards Institution (BSI)
- Status
- 2024-04
- Replace By
- BS EN ISO 8362-2:2024
- Latest
- BS EN ISO 8362-2:2024
- Scope
- 1 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.
BS EN ISO 8362-2:2015+A1:2022 Referenced Document
- ISO 3302-1 Rubber - Tolerances for products - Part 1: Dimensional tolerances
- ISO 3302-2 Rubber — Tolerances for products — Part 2: Geometrical tolerances
- ISO 8362-1 Injection containers and accessories - Part 1: Injection vials made of glass tubing
- ISO 8362-4 Injection containers and accessories - Part 4: Injection vials made of moulded glass
- 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
BS EN ISO 8362-2:2015+A1:2022 history
- 2024 BS EN ISO 8362-2:2024 Injection containers and accessories - Closures for injection vials
- 2022 BS EN ISO 8362-2:2015+A1:2022 Injection containers and accessories - Closures for injection vials
- 2015 BS EN ISO 8362-2:2015 Injection containers and accessories. Closures for injection vials
- 2010 BS EN ISO 8362-2:2010 Injection containers and accessories. Part 2: Closures for injection vials
