{"id":458180,"date":"2024-10-20T09:55:21","date_gmt":"2024-10-20T09:55:21","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-8362-22024-tc\/"},"modified":"2024-10-26T18:26:53","modified_gmt":"2024-10-26T18:26:53","slug":"bs-en-iso-8362-22024-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-8362-22024-tc\/","title":{"rendered":"BS EN ISO 8362-2:2024 – TC"},"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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21<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
23<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
26<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
28<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
29<\/td>\n | 4 Classification 5 Shape and dimensions <\/td>\n<\/tr>\n | ||||||
31<\/td>\n | 6 Designation 7 Material 8 Performance requirements 8.1 General <\/td>\n<\/tr>\n | ||||||
32<\/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 | ||||||
33<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Tracked Changes. Injection containers and accessories – Closures for injection vials<\/b><\/p>\n |