{"id":277764,"date":"2024-10-19T18:42:29","date_gmt":"2024-10-19T18:42:29","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-5840-12015\/"},"modified":"2024-10-25T15:13:44","modified_gmt":"2024-10-25T15:13:44","slug":"bs-en-iso-5840-12015","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-5840-12015\/","title":{"rendered":"BS EN ISO 5840-1:2015"},"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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
4<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
5<\/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
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
10<\/td>\n1\tScope
2\tNormative references <\/td>\n<\/tr>\n
11<\/td>\n3\tTerms and definitions <\/td>\n<\/tr>\n
20<\/td>\n4\tAbbreviations <\/td>\n<\/tr>\n
21<\/td>\n5\tFundamental requirements
6\tDevice description
6.1\tIntended use
6.2\tDesign inputs
6.2.1\tOperational specifications
6.2.2\tPerformance specifications
6.2.3\tImplant procedure <\/td>\n<\/tr>\n
22<\/td>\n6.2.4\tPackaging, labelling, and sterilization
6.3\tDesign outputs <\/td>\n<\/tr>\n
23<\/td>\n6.4\tDesign transfer (manufacturing verification\/validation)
6.5\tRisk management <\/td>\n<\/tr>\n
24<\/td>\n7\tDesign verification testing and analysis\/design validation
7.1\tGeneral requirements
7.2\tIn vitro assessment
7.3\tPreclinical in vivo evaluation
7.4\tClinical investigations <\/td>\n<\/tr>\n
25<\/td>\nAnnex\u00a0A (informative) Rationale for the provisions of this part of ISO\u00a05480 <\/td>\n<\/tr>\n
28<\/td>\nAnnex\u00a0B (normative) Packaging <\/td>\n<\/tr>\n
29<\/td>\nAnnex\u00a0C (normative) Product labels, instructions for use, and training <\/td>\n<\/tr>\n
32<\/td>\nAnnex\u00a0D (normative) Sterilization <\/td>\n<\/tr>\n
33<\/td>\nAnnex\u00a0E (informative) In vitro test guidelines for paediatric devices <\/td>\n<\/tr>\n
37<\/td>\nAnnex\u00a0F (informative) Statistical procedures when using in vitro performance criteria <\/td>\n<\/tr>\n
38<\/td>\nAnnex\u00a0G (informative) Examples and definitions of some physical and material properties of heart valve systems <\/td>\n<\/tr>\n
49<\/td>\nAnnex\u00a0H (informative) Examples of standards applicable to testing of materials and components of heart valve systems <\/td>\n<\/tr>\n
55<\/td>\nAnnex\u00a0I (informative) Raw and post-conditioning mechanical properties for support structure materials <\/td>\n<\/tr>\n
57<\/td>\nAnnex\u00a0J (informative) Corrosion assessment <\/td>\n<\/tr>\n
60<\/td>\nAnnex\u00a0K (informative) Echocardiographic protocol <\/td>\n<\/tr>\n
63<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Cardiovascular implants. Cardiac valve prostheses – General requirements<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2015<\/td>\n68<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":277769,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-277764","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\/277764","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\/277769"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=277764"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=277764"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=277764"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}