{"id":460258,"date":"2024-10-20T10:08:43","date_gmt":"2024-10-20T10:08:43","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-8362-22024-3\/"},"modified":"2024-10-26T18:45:16","modified_gmt":"2024-10-26T18:45:16","slug":"bs-en-iso-8362-22024-3","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-8362-22024-3\/","title":{"rendered":"BS EN ISO 8362-2:2024"},"content":{"rendered":"
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.<\/p>\n
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2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
4<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | 4 Classification 5 Shape and dimensions <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | 6 Designation 7 Material 8 Performance requirements 8.1 General <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Injection containers and accessories – Closures for injection vials<\/b><\/p>\n |