{"id":363806,"date":"2024-10-20T01:47:33","date_gmt":"2024-10-20T01:47:33","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-5840-22021\/"},"modified":"2024-10-26T02:49:19","modified_gmt":"2024-10-26T02:49:19","slug":"bs-en-iso-5840-22021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-5840-22021\/","title":{"rendered":"BS EN ISO 5840-2:2021"},"content":{"rendered":"

This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E<\/span> for examples of surgical heart valve substitutes and their components.<\/p>\n

This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.<\/p>\n

This document establishes an approach for verifying\/validating the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo<\/i> evaluation and clinical evaluation of the finished surgical heart valve substitute.<\/p>\n

This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and\/or clinical evidence exists for their justification.<\/p>\n

For some heart valve substitutes (e.g. sutureless), the requirements of both this document and ISO 5840-3:2021<\/span><\/span> can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis.<\/p>\n

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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
4<\/td>\nEuropean foreword
Endorsement notice <\/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
3 Terms and definitions <\/td>\n<\/tr>\n
11<\/td>\n4 Abbreviations <\/td>\n<\/tr>\n
12<\/td>\n5 Fundamental requirements
6 Device description
6.1 General
6.2 Intended use
6.3 Design inputs
6.3.1 Operational specifications
6.3.2 Performance specifications <\/td>\n<\/tr>\n
13<\/td>\n6.3.3 Packaging, labelling, and sterilization
6.4 Design outputs
6.5 Design transfer (manufacturing verification\/validation) <\/td>\n<\/tr>\n
14<\/td>\n6.6 Risk management
7 Design verification and validation
7.1 General requirements
7.2 In vitro assessment
7.2.1 General
7.2.2 Test conditions, sample selection, and reporting requirements
7.2.3 Material property assessment
7.2.4 Hydrodynamic performance assessment <\/td>\n<\/tr>\n
15<\/td>\n7.2.5 Structural performance assessment <\/td>\n<\/tr>\n
16<\/td>\n7.2.6 Design- or procedure-specific testing
7.2.7 Device MRI compatibility
7.2.8 Simulated use
7.2.9 Human factors\/usability assessment
7.2.10 Implant thrombogenic and haemolytic potential assessment
7.3 Preclinical in vivo evaluation
7.3.1 General
7.3.2 Overall requirements <\/td>\n<\/tr>\n
17<\/td>\n7.3.3 Methods <\/td>\n<\/tr>\n
18<\/td>\n7.3.4 Test report <\/td>\n<\/tr>\n
19<\/td>\n7.4 Clinical investigations
7.4.1 General <\/td>\n<\/tr>\n
20<\/td>\n7.4.2 Study considerations <\/td>\n<\/tr>\n
21<\/td>\n7.4.3 Study endpoints <\/td>\n<\/tr>\n
22<\/td>\n7.4.4 Ethical considerations
7.4.5 Pivotal studies: Distribution of subjects and investigators <\/td>\n<\/tr>\n
23<\/td>\n7.4.6 Statistical considerations including sample size and duration <\/td>\n<\/tr>\n
24<\/td>\n7.4.7 Patient selection criteria <\/td>\n<\/tr>\n
25<\/td>\n7.4.8 Valve thrombosis prevention
7.4.9 Clinical data requirements <\/td>\n<\/tr>\n
30<\/td>\nAnnex A (informative) Surgical heart valve substitute hazard analysis example <\/td>\n<\/tr>\n
32<\/td>\nAnnex B (informative) In vitro procedures for testing unstented or similar valves in compliant chambers <\/td>\n<\/tr>\n
34<\/td>\nAnnex C (informative) Preclinical in vivo evaluation <\/td>\n<\/tr>\n
37<\/td>\nAnnex D (informative) Description of the surgical heart valve substitute and system <\/td>\n<\/tr>\n
39<\/td>\nAnnex E (informative) Examples of components of some surgical heart valve substitutes and systems <\/td>\n<\/tr>\n
45<\/td>\nAnnex F (informative) Guidelines for verification of hydrodynamic performance \u2014 Pulsatile flow testing <\/td>\n<\/tr>\n
49<\/td>\nAnnex G (informative) Examples of design specific testing <\/td>\n<\/tr>\n
51<\/td>\nAnnex H (informative) Fatigue assessment <\/td>\n<\/tr>\n
53<\/td>\nAnnex I (normative) Methods of evaluating clinical data against objective performance criteria <\/td>\n<\/tr>\n
54<\/td>\nAnnex J (normative) Adverse event classification during clinical investigation <\/td>\n<\/tr>\n
59<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Cardiovascular implants. Cardiac valve prostheses – Surgically implanted heart valve substitutes<\/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>\n60<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":363815,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-363806","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\/363806","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\/363815"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=363806"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=363806"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=363806"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}