{"id":391768,"date":"2024-10-20T04:01:04","date_gmt":"2024-10-20T04:01:04","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-224132021-tc\/"},"modified":"2024-10-26T07:27:05","modified_gmt":"2024-10-26T07:27:05","slug":"bs-en-iso-224132021-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-224132021-tc\/","title":{"rendered":"BS EN ISO 22413:2021 – TC"},"content":{"rendered":"
This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.<\/p>\n
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
38<\/td>\n | National foreword <\/td>\n<\/tr>\n | ||||||
40<\/td>\n | European foreword <\/td>\n<\/tr>\n | ||||||
42<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
43<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
45<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
46<\/td>\n | 4 Design and designation 4.1 Design for transfer sets without housing <\/td>\n<\/tr>\n | ||||||
49<\/td>\n | 4.2 Design for a transfer set with housing 4.3 Designation 5 Materials 6 Physical requirements 6.1 Particulate contamination 6.2 Tensile strength <\/td>\n<\/tr>\n | ||||||
50<\/td>\n | 6.3 Leakage 6.4 Free flow 6.5 Piercing device 6.6 Penetration force 6.7 Fragmentation <\/td>\n<\/tr>\n | ||||||
51<\/td>\n | 6.8 Air inlet and air outlet 6.9 Protective caps 6.10 Transfer sets with housing 6.11 Small-bore connectors 6.12 Fluid filter 7 Chemical requirements 8 Biological requirements 9 Packaging <\/td>\n<\/tr>\n | ||||||
52<\/td>\n | 10 Labelling 10.1 General 10.2 Unit container 10.3 Shelf or multi-unit container <\/td>\n<\/tr>\n | ||||||
53<\/td>\n | 11 Disposal <\/td>\n<\/tr>\n | ||||||
54<\/td>\n | Annex A (normative) Physical tests <\/td>\n<\/tr>\n | ||||||
58<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Tracked Changes. Transfer sets for pharmaceutical preparations. Requirements and test methods<\/b><\/p>\n |