{"id":425250,"date":"2024-10-20T06:55:49","date_gmt":"2024-10-20T06:55:49","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-pd-iso-tr-244842023\/"},"modified":"2024-10-26T13:03:34","modified_gmt":"2024-10-26T13:03:34","slug":"bsi-pd-iso-tr-244842023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-pd-iso-tr-244842023\/","title":{"rendered":"BSI PD ISO\/TR 24484:2023"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
2<\/td>\n | National 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 Quality of design 4.1 General 4.2 Design input and design development 4.2.1 General <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | 4.2.2 Barrier sheath 4.2.3 Product insertion feature and retention feature <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | 4.2.4 Dressing materials 4.2.5 Lubricants 4.2.6 Biocompatibility 4.2.7 Control of bioburden 4.2.8 Packaging <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 4.3 Design verification 4.4 Design validation 4.4.1 Evaluation of barrier properties 4.4.2 Clinical (human use) investigations 4.4.3 Stability studies and shelf-life claim <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 4.5 Design output 4.5.1 General 4.5.2 Details of materials 4.5.3 Specifications of the female condoms <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 4.5.4 Supporting information 4.5.5 Regulatory compliance 4.6 Design transfer 4.7 Validation and change controls 5 Risk management <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 6 Quality in manufacture <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | 7 Quality in testing 7.1 General <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | 7.2 Test equipment 7.3 Sampling and testing: 7.4 Training and competence of personnel in testing 7.5 Review of results and reports: <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | 8 Quality in procurement 9 Handling and disposal of used female condoms <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Female condoms. Use of ISO 25841 and the quality management of female condoms<\/b><\/p>\n |