{"id":385177,"date":"2024-10-20T03:29:28","date_gmt":"2024-10-20T03:29:28","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-226792021\/"},"modified":"2024-10-26T06:19:42","modified_gmt":"2024-10-26T06:19:42","slug":"bs-iso-226792021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-226792021\/","title":{"rendered":"BS ISO 22679:2021"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 4 Abbreviations <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 5 Fundamental requirements 5.1 General 5.2 Risk management <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 6 Device description 6.1 General 6.2 Intended use 6.3 Design inputs 6.3.1 Operational principles and specifications 6.3.2 Functional, performance and safety requirements <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 6.3.3 Implant procedure: Device and usability requirements <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | 6.3.4 Packaging, labelling and sterilization 6.4 Design outputs 6.5 Design transfer (manufacturing verification or validation) 7 Design verification and validation 7.1 General requirements <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | 7.2 In vitro assessment 7.2.1 General 7.2.2 Test conditions, sample selection and reporting requirements <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | 7.2.3 Material property assessment <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | 7.2.4 Structural performance assessment <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | 7.2.5 Component corrosion assessment 7.2.6 Visibility <\/td>\n<\/tr>\n | ||||||
23<\/td>\n | 7.2.7 Visual inspection 7.2.8 Dimensional verification 7.2.9 Device MRI compatibility 7.2.10 Simulated use assessment 7.2.11 Usability engineering process 7.2.12 Design- or procedure-specific testing 7.3 Preclinical in vivo evaluation 7.3.1 General 7.3.2 Overall requirements <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | 7.3.3 Methods <\/td>\n<\/tr>\n | ||||||
26<\/td>\n | 7.3.4 Test report <\/td>\n<\/tr>\n | ||||||
27<\/td>\n | 7.4 Clinical investigations 7.4.1 General <\/td>\n<\/tr>\n | ||||||
28<\/td>\n | 7.4.2 Study considerations <\/td>\n<\/tr>\n | ||||||
29<\/td>\n | 7.4.3 Imaging assessment 7.4.4 Study design 7.4.5 Explant analysis <\/td>\n<\/tr>\n | ||||||
30<\/td>\n | 7.4.6 Pilot study considerations 7.4.7 Study endpoints 7.4.8 Ethical considerations <\/td>\n<\/tr>\n | ||||||
31<\/td>\n | 7.4.9 Pivotal studies: Distribution of subjects and investigators 7.4.10 Site qualification and training requirements 7.4.11 Study population <\/td>\n<\/tr>\n | ||||||
32<\/td>\n | 7.4.12 Statistical considerations <\/td>\n<\/tr>\n | ||||||
33<\/td>\n | 7.4.13 Sample size 7.4.14 Duration of study 7.4.15 Patient selection criteria <\/td>\n<\/tr>\n | ||||||
34<\/td>\n | 7.4.16 Clinical data requirements <\/td>\n<\/tr>\n | ||||||
39<\/td>\n | Annex A (informative) Rationale for the provisions of this document <\/td>\n<\/tr>\n | ||||||
42<\/td>\n | Annex B (informative) Transcatheter cardiac occluder hazard analysis example <\/td>\n<\/tr>\n | ||||||
44<\/td>\n | Annex C (normative) Packaging <\/td>\n<\/tr>\n | ||||||
45<\/td>\n | Annex D (normative) Product labels and instructions for use <\/td>\n<\/tr>\n | ||||||
46<\/td>\n | Annex E (normative) Sterilization <\/td>\n<\/tr>\n | ||||||
47<\/td>\n | Annex F (informative) Corrosion assessment <\/td>\n<\/tr>\n | ||||||
50<\/td>\n | Annex G (informative) In vitro test guidelines for paediatric devices <\/td>\n<\/tr>\n | ||||||
52<\/td>\n | Annex H (informative) Fatigue and durability assessment <\/td>\n<\/tr>\n | ||||||
58<\/td>\n | Annex I (normative) Adverse event classification during clinical investigation <\/td>\n<\/tr>\n | ||||||
63<\/td>\n | Annex J (informative) Imaging protocol <\/td>\n<\/tr>\n | ||||||
64<\/td>\n | Annex K (informative) Clinical investigation endpoints for transcatheter cardiac occluders: Suggestions for endpoints and their timing <\/td>\n<\/tr>\n | ||||||
67<\/td>\n | Annex L (informative) Examples of design specific testing <\/td>\n<\/tr>\n | ||||||
69<\/td>\n | Annex M (informative) Guidelines for delivery system design evaluation <\/td>\n<\/tr>\n | ||||||
71<\/td>\n | Annex N (normative) Preclinical in vivo evaluation <\/td>\n<\/tr>\n | ||||||
74<\/td>\n | Annex O (informative) In vitro test pressure guidelines <\/td>\n<\/tr>\n | ||||||
76<\/td>\n | Annex P (informative) Training for physicians and support staff <\/td>\n<\/tr>\n | ||||||
77<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Cardiovascular implants. Transcatheter cardiac occluders<\/b><\/p>\n |