{"id":415739,"date":"2024-10-20T06:06:54","date_gmt":"2024-10-20T06:06:54","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-224132021-2\/"},"modified":"2024-10-26T11:22:02","modified_gmt":"2024-10-26T11:22:02","slug":"bs-en-iso-224132021-2","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-224132021-2\/","title":{"rendered":"BS EN ISO 22413:2021"},"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 | ||||||
---|---|---|---|---|---|---|---|
2<\/td>\n | National foreword <\/td>\n<\/tr>\n | ||||||
4<\/td>\n | European foreword <\/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 Design and designation 4.1 Design for transfer sets without housing <\/td>\n<\/tr>\n | ||||||
13<\/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 | ||||||
14<\/td>\n | 6.3 Leakage 6.4 Free flow 6.5 Piercing device 6.6 Penetration force 6.7 Fragmentation <\/td>\n<\/tr>\n | ||||||
15<\/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 | ||||||
16<\/td>\n | 10 Labelling 10.1 General 10.2 Unit container 10.3 Shelf or multi-unit container <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 11 Disposal <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | Annex A (normative) Physical tests <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Transfer sets for pharmaceutical preparations. Requirements and test methods<\/b><\/p>\n |