{"id":278309,"date":"2024-10-19T18:45:21","date_gmt":"2024-10-19T18:45:21","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-5840-22015-tc\/"},"modified":"2024-10-25T15:17:48","modified_gmt":"2024-10-25T15:17:48","slug":"bs-en-iso-5840-22015-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-5840-22015-tc\/","title":{"rendered":"BS EN ISO 5840-2:2015 – TC"},"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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
124<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
125<\/td>\nAnnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93\/42\/EEC on medical devices
Table ZA.1 \u2014 Correspondence between this European Standard and Directive 93\/42\/EEC on medical devices <\/td>\n<\/tr>\n
128<\/td>\nForeword <\/td>\n<\/tr>\n
129<\/td>\nIntroduction <\/td>\n<\/tr>\n
130<\/td>\n1\tScope
2\tNormative references <\/td>\n<\/tr>\n
131<\/td>\n3\tTerms and definitions <\/td>\n<\/tr>\n
133<\/td>\n4\tAbbreviations
5\tFundamental requirements <\/td>\n<\/tr>\n
134<\/td>\n6\tDevice description
6.1\tIntended use
6.2\tDesign inputs
6.2.1\tOperational specifications
6.2.2\tPerformance specifications <\/td>\n<\/tr>\n
135<\/td>\n6.2.3\tPackaging, labelling, and sterilization
6.3\tDesign outputs
6.3.1\tGeneral
6.4\tDesign transfer (manufacturing qualification)
6.5\tRisk management
7\tDesign verification testing and analysis\/design validation
7.1\tGeneral requirements <\/td>\n<\/tr>\n
136<\/td>\n7.2\tIn vitro assessment
7.2.1\tTest conditions, sample selection, and reporting requirements <\/td>\n<\/tr>\n
137<\/td>\n7.2.2\tMaterial property assessment
7.2.3\tHydrodynamic performance assessment <\/td>\n<\/tr>\n
139<\/td>\n7.2.4\tStructural performance assessment <\/td>\n<\/tr>\n
140<\/td>\n7.2.5\tDevice MRI safety
7.2.6\tAdditional implant design evaluation requirements <\/td>\n<\/tr>\n
141<\/td>\n7.2.7\tDesign specific testing
7.2.8\tSimulated use
7.2.9\tHuman factors\/usability assessment
7.3\tPreclinical in vivo evaluation
7.3.1\tOverall requirements <\/td>\n<\/tr>\n
142<\/td>\n7.3.2\tMethods <\/td>\n<\/tr>\n
143<\/td>\n7.3.3\tTest report <\/td>\n<\/tr>\n
144<\/td>\n7.4\tClinical investigation
7.4.1\tGeneral
7.4.2\tStatistical considerations
7.4.3\tDistribution of subjects and investigators
7.4.4\tSample size <\/td>\n<\/tr>\n
145<\/td>\n7.4.5\tEntry criteria
7.4.6\tDuration of the study
7.4.7\tClinical data requirements <\/td>\n<\/tr>\n
147<\/td>\n7.4.8\tClinical investigation report <\/td>\n<\/tr>\n
149<\/td>\nAnnex\u00a0A (informative) Heart valve substitute hazards, associated failure modes, and evaluation methods <\/td>\n<\/tr>\n
152<\/td>\nAnnex\u00a0B (informative) In vitro procedures for testing unstented or similar valves in compliant chambers <\/td>\n<\/tr>\n
154<\/td>\nAnnex\u00a0C (informative) Preclinical in vivo evaluation <\/td>\n<\/tr>\n
157<\/td>\nAnnex\u00a0D (informative) Description of the surgical heart valve substitute <\/td>\n<\/tr>\n
159<\/td>\nAnnex\u00a0E (informative) Examples of components of some surgical heart valve substitutes <\/td>\n<\/tr>\n
163<\/td>\nAnnex\u00a0F (informative) Guidelines for verification of hydrodynamic performance <\/td>\n<\/tr>\n
172<\/td>\nAnnex\u00a0G (informative) Durability testing <\/td>\n<\/tr>\n
174<\/td>\nAnnex\u00a0H (informative) Examples of design specific testing <\/td>\n<\/tr>\n
176<\/td>\nAnnex\u00a0I (informative) Fatigue assessment <\/td>\n<\/tr>\n
182<\/td>\nAnnex\u00a0J (normative) Methods of evaluating clinical data <\/td>\n<\/tr>\n
183<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Tracked Changes. 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>\n2020<\/td>\n186<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":278312,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-278309","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\/278309","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\/278312"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=278309"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=278309"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=278309"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}