{"id":431300,"date":"2024-10-20T07:27:28","date_gmt":"2024-10-20T07:27:28","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-11608-52023-tc\/"},"modified":"2024-10-26T14:10:41","modified_gmt":"2024-10-26T14:10:41","slug":"bs-en-iso-11608-52023-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-11608-52023-tc\/","title":{"rendered":"BS EN ISO 11608-5:2023 – TC"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
1<\/td>\n | 30472380 <\/td>\n<\/tr>\n | ||||||
49<\/td>\n | A-30461612 <\/td>\n<\/tr>\n | ||||||
50<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
52<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
54<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
55<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
57<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
58<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
60<\/td>\n | 4 Requirements 4.1 General requirements <\/td>\n<\/tr>\n | ||||||
61<\/td>\n | 4.2 Medicinal product preparation <\/td>\n<\/tr>\n | ||||||
62<\/td>\n | 4.3 Needle preparation 4.4 Needle hiding 4.5 Priming 4.6 Dose setting 4.7 Needle insertion 4.8 Injection depth control <\/td>\n<\/tr>\n | ||||||
63<\/td>\n | 4.9 Dose delivery 4.10 Recording of device functions 4.11 Needle retraction 4.11.1 Completion of dose delivery 4.11.2 Needle retraction distance 4.11.3 Communication of completion 4.12 Disabling the NIS-AUTO <\/td>\n<\/tr>\n | ||||||
64<\/td>\n | 4.13 Needle shielding 4.13.1 General 4.13.2 Needle shielding before injection 4.13.3 Needle shielding after injection 4.14 Needle removal from the NIS-AUTO 5 Test methods 5.1 General <\/td>\n<\/tr>\n | ||||||
65<\/td>\n | 5.2 Test conditions 5.3 Actuation 5.4 Medicinal product preparation 5.5 Needle inspection 5.6 Needle hiding <\/td>\n<\/tr>\n | ||||||
66<\/td>\n | 5.7 Priming 5.8 Needle extension 5.9 Injection time <\/td>\n<\/tr>\n | ||||||
67<\/td>\n | 5.10 Dose accuracy 5.11 Retracted position 5.12 Disabling the NIS-AUTO 5.13 Needle shielding 5.13.1 Needle shielding before and after injection 5.13.2 Needle shielding after free fall 6 Information supplied with the NIS-AUTO <\/td>\n<\/tr>\n | ||||||
68<\/td>\n | Annex A (informative) Rationale for requirements <\/td>\n<\/tr>\n | ||||||
70<\/td>\n | Annex B (informative) Example of a test method for dose accuracy at intended injection depth <\/td>\n<\/tr>\n | ||||||
72<\/td>\n | Annex C (informative) Needle extension and intended injection depth <\/td>\n<\/tr>\n | ||||||
78<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Tracked Changes. Needle-based injection systems for medical use. Requirements and test methods – Automated functions<\/b><\/p>\n |