BS EN ISO 8362-2:2024
$102.76
Injection containers and accessories – Closures for injection vials
| Published By | Publication Date | Number of Pages |
| BSI | 2024 | 16 |
This document 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 document 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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 4 | European foreword Endorsement notice |
| 6 | Foreword |
| 7 | Introduction |
| 9 | 1 Scope 2 Normative references 3 Terms and definitions |
| 10 | 4 Classification 5 Shape and dimensions |
| 12 | 6 Designation 7 Material 8 Performance requirements 8.1 General |
| 13 | 8.2 Physical requirements 8.2.1 Hardness 8.2.2 Penetrability 8.2.3 Fragmentation 8.2.4 Self-sealing and aqueous solution tightness test 8.2.5 Aqueous solution tightness 8.2.6 Resistance to ageing 8.3 Chemical requirements 8.4 Biological requirements 8.5 Particulate contamination requirements 9 Labelling |
| 14 | Bibliography |
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