{"id":464888,"date":"2024-10-20T10:37:29","date_gmt":"2024-10-20T10:37:29","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-59102024-2\/"},"modified":"2024-10-26T19:35:49","modified_gmt":"2024-10-26T19:35:49","slug":"bs-iso-59102024-2","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-59102024-2\/","title":{"rendered":"BS ISO 5910:2024"},"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
9<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
10<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
17<\/td>\n4 Abbreviated terms <\/td>\n<\/tr>\n
18<\/td>\n5 Fundamental requirements
5.1 General
5.2 Risk management
6 Device design
6.1 Intended use and indication for use
6.2 Design inputs
6.2.1 General
6.2.2 Operational specifications <\/td>\n<\/tr>\n
20<\/td>\n6.2.3 Functional, performance and safety requirements <\/td>\n<\/tr>\n
21<\/td>\n6.2.4 Usability
6.2.5 Packaging, labelling and sterilization
6.3 Design outputs
6.4 Design transfer (manufacturing verification and validation) <\/td>\n<\/tr>\n
22<\/td>\n7 Design verification testing and analysis, and design validation
7.1 General requirements
7.2 In vitro assessment
7.2.1 General
7.2.2 Test articles, sample selection, test conditions and reporting requirements <\/td>\n<\/tr>\n
24<\/td>\n7.2.3 Device material property assessment <\/td>\n<\/tr>\n
25<\/td>\n7.2.4 Device durability assessment
7.2.5 Device corrosion assessment
7.2.6 Design specific testing
7.2.7 Visibility <\/td>\n<\/tr>\n
26<\/td>\n7.2.8 Simulated use assessment
7.2.9 Human factors and usability assessment
7.2.10 Device MRI safety
7.3 Preclinical in vivo evaluation
7.3.1 General
7.3.2 Overall requirements <\/td>\n<\/tr>\n
28<\/td>\n7.3.3 Methods <\/td>\n<\/tr>\n
29<\/td>\n7.3.4 Test report <\/td>\n<\/tr>\n
30<\/td>\n7.4 Clinical investigations
7.4.1 General
7.4.2 Study considerations <\/td>\n<\/tr>\n
32<\/td>\n7.4.3 Study end points <\/td>\n<\/tr>\n
33<\/td>\n7.4.4 Ethical considerations
7.4.5 Distribution of subjects and investigators <\/td>\n<\/tr>\n
34<\/td>\n7.4.6 Statistical considerations including sample size and duration <\/td>\n<\/tr>\n
35<\/td>\n7.4.7 Patient selection criteria <\/td>\n<\/tr>\n
36<\/td>\n7.4.8 Clinical data requirements <\/td>\n<\/tr>\n
39<\/td>\n7.4.9 Clinical investigation analysis and reporting
7.4.10 Post-market clinical follow-up <\/td>\n<\/tr>\n
40<\/td>\n8 Manufacturing verification and validation <\/td>\n<\/tr>\n
41<\/td>\nAnnex A (informative) Rationale for the provisions of this document <\/td>\n<\/tr>\n
44<\/td>\nAnnex B (informative) Types and examples of heart valve repair devices and delivery systems <\/td>\n<\/tr>\n
51<\/td>\nAnnex C (normative) Packaging <\/td>\n<\/tr>\n
52<\/td>\nAnnex D (normative) Product labels, instructions for use and training <\/td>\n<\/tr>\n
55<\/td>\nAnnex E (normative) Sterilization <\/td>\n<\/tr>\n
56<\/td>\nAnnex F (informative) Heart valve repair system characteristics <\/td>\n<\/tr>\n
58<\/td>\nAnnex G (informative) Example of a transcatheter heart valve repair system hazard analysis <\/td>\n<\/tr>\n
59<\/td>\nAnnex H (informative) In vitro test guidelines for paediatric devices <\/td>\n<\/tr>\n
62<\/td>\nAnnex I (informative) Identification of boundary conditions <\/td>\n<\/tr>\n
66<\/td>\nAnnex J (informative) Test platforms for in vitro testing <\/td>\n<\/tr>\n
68<\/td>\nAnnex K (informative) Considerations for device material properties undergoing alterations post implantation <\/td>\n<\/tr>\n
69<\/td>\nAnnex L (informative) Corrosion assessment <\/td>\n<\/tr>\n
72<\/td>\nAnnex M (informative) Durability assessment <\/td>\n<\/tr>\n
79<\/td>\nAnnex N (informative) Additional device design evaluation considerations <\/td>\n<\/tr>\n
82<\/td>\nAnnex O (normative) Delivery system design evaluation <\/td>\n<\/tr>\n
84<\/td>\nAnnex P (informative) Preclinical ex vivo and in vivo evaluations <\/td>\n<\/tr>\n
88<\/td>\nAnnex Q (normative) Adverse event classification during clinical investigation <\/td>\n<\/tr>\n
94<\/td>\nAnnex R (informative) Multimodality imaging of TAVr, TMVr and TTVr (pre-, peri- and post-implantation) <\/td>\n<\/tr>\n
99<\/td>\nAnnex S (informative) Clinical investigation end points for valve repair devices: Suggestions for end points and their timing <\/td>\n<\/tr>\n
103<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Cardiovascular implants and extracorporeal systems. Cardiac valve repair devices<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2024<\/td>\n108<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":464895,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-464888","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\/464888","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\/464895"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=464888"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=464888"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=464888"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}