{"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 Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
10<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
14<\/td>\n4 Abbreviations <\/td>\n<\/tr>\n
15<\/td>\n5 Fundamental requirements
5.1 General
5.2 Risk management <\/td>\n<\/tr>\n
16<\/td>\n6 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>\n6.3.3 Implant procedure: Device and usability requirements <\/td>\n<\/tr>\n
18<\/td>\n6.3.4 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>\n7.2 In vitro assessment
7.2.1 General
7.2.2 Test conditions, sample selection and reporting requirements <\/td>\n<\/tr>\n
20<\/td>\n7.2.3 Material property assessment <\/td>\n<\/tr>\n
21<\/td>\n7.2.4 Structural performance assessment <\/td>\n<\/tr>\n
22<\/td>\n7.2.5 Component corrosion assessment
7.2.6 Visibility <\/td>\n<\/tr>\n
23<\/td>\n7.2.7 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>\n7.3.3 Methods <\/td>\n<\/tr>\n
26<\/td>\n7.3.4 Test report <\/td>\n<\/tr>\n
27<\/td>\n7.4 Clinical investigations
7.4.1 General <\/td>\n<\/tr>\n
28<\/td>\n7.4.2 Study considerations <\/td>\n<\/tr>\n
29<\/td>\n7.4.3 Imaging assessment
7.4.4 Study design
7.4.5 Explant analysis <\/td>\n<\/tr>\n
30<\/td>\n7.4.6 Pilot study considerations
7.4.7 Study endpoints
7.4.8 Ethical considerations <\/td>\n<\/tr>\n
31<\/td>\n7.4.9 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>\n7.4.12 Statistical considerations <\/td>\n<\/tr>\n
33<\/td>\n7.4.13 Sample size
7.4.14 Duration of study
7.4.15 Patient selection criteria <\/td>\n<\/tr>\n
34<\/td>\n7.4.16 Clinical data requirements <\/td>\n<\/tr>\n
39<\/td>\nAnnex A (informative) Rationale for the provisions of this document <\/td>\n<\/tr>\n
42<\/td>\nAnnex B (informative) Transcatheter cardiac occluder hazard analysis example <\/td>\n<\/tr>\n
44<\/td>\nAnnex C (normative) Packaging <\/td>\n<\/tr>\n
45<\/td>\nAnnex D (normative) Product labels and instructions for use <\/td>\n<\/tr>\n
46<\/td>\nAnnex E (normative) Sterilization <\/td>\n<\/tr>\n
47<\/td>\nAnnex F (informative) Corrosion assessment <\/td>\n<\/tr>\n
50<\/td>\nAnnex G (informative) In vitro test guidelines for paediatric devices <\/td>\n<\/tr>\n
52<\/td>\nAnnex H (informative) Fatigue and durability assessment <\/td>\n<\/tr>\n
58<\/td>\nAnnex I (normative) Adverse event classification during clinical investigation <\/td>\n<\/tr>\n
63<\/td>\nAnnex J (informative) Imaging protocol <\/td>\n<\/tr>\n
64<\/td>\nAnnex K (informative) Clinical investigation endpoints for transcatheter cardiac occluders: Suggestions for endpoints and their timing <\/td>\n<\/tr>\n
67<\/td>\nAnnex L (informative) Examples of design specific testing <\/td>\n<\/tr>\n
69<\/td>\nAnnex M (informative) Guidelines for delivery system design evaluation <\/td>\n<\/tr>\n
71<\/td>\nAnnex N (normative) Preclinical in vivo evaluation <\/td>\n<\/tr>\n
74<\/td>\nAnnex O (informative) In vitro test pressure guidelines <\/td>\n<\/tr>\n
76<\/td>\nAnnex P (informative) Training for physicians and support staff <\/td>\n<\/tr>\n
77<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Cardiovascular implants. Transcatheter cardiac occluders<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2021<\/td>\n82<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":385186,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-385177","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-40","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/385177","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/385186"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=385177"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=385177"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=385177"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}