{"id":277640,"date":"2024-10-19T18:41:51","date_gmt":"2024-10-19T18:41:51","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-5840-32013\/"},"modified":"2024-10-25T15:12:45","modified_gmt":"2024-10-25T15:12:45","slug":"bs-en-iso-5840-32013","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-5840-32013\/","title":{"rendered":"BS EN ISO 5840-3:2013"},"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\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\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
5<\/td>\nAnnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93\/42\/EEC <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\nSection sec_1
Section sec_2
1\tScope
2\tNormative references <\/td>\n<\/tr>\n
12<\/td>\nSection sec_3
3\tTerms and definitions <\/td>\n<\/tr>\n
14<\/td>\nTable tab_a
Figure fig_1 <\/td>\n<\/tr>\n
18<\/td>\nTable tab_c
Figure fig_2 <\/td>\n<\/tr>\n
20<\/td>\nSection sec_4
Section sec_5
Section sec_6
Section sec_6.1
Section sec_6.2
Section sec_6.2.1
4\tAbbreviations
5\tFundamental requirements
6\tDevice description
6.1\tIntended use
6.2\tDesign inputs <\/td>\n<\/tr>\n
21<\/td>\nTable tab_1
Table tab_2 <\/td>\n<\/tr>\n
22<\/td>\nSection sec_6.2.2
Section sec_6.2.2.1
Section sec_6.2.2.2 <\/td>\n<\/tr>\n
23<\/td>\nSection sec_6.2.2.3
Section sec_6.2.3
Section sec_6.2.4
Section sec_6.3
Section sec_6.4
6.3\tDesign outputs
6.4\tDesign transfer (manufacturing verification\/validation) <\/td>\n<\/tr>\n
24<\/td>\nSection sec_6.5
Section sec_7
Section sec_7.1
Section sec_7.2
Section sec_7.2.1
Section sec_7.2.1.1
Section sec_7.2.1.2
Section sec_7.2.1.3
Section sec_7.2.1.4
Section sec_7.2.1.5
6.5\tRisk management
7\tDesign verification testing and analysis\/design validation
7.1\tGeneral requirements
7.2\tIn vitro assessment <\/td>\n<\/tr>\n
25<\/td>\nSection sec_7.2.1.6
Section sec_7.2.2
Section sec_7.2.2.1
Section sec_7.2.2.2
Section sec_7.2.2.3 <\/td>\n<\/tr>\n
26<\/td>\nSection sec_7.2.3
Table tab_3 <\/td>\n<\/tr>\n
27<\/td>\nTable tab_4 <\/td>\n<\/tr>\n
28<\/td>\nSection sec_7.2.4
Section sec_7.2.4.1
Section sec_7.2.4.2 <\/td>\n<\/tr>\n
29<\/td>\nSection sec_7.2.4.3
Section sec_7.2.5
Section sec_7.2.5.1 <\/td>\n<\/tr>\n
30<\/td>\nSection sec_7.2.5.2
Section sec_7.2.5.3
Section sec_7.2.5.4
Section sec_7.2.5.5
Section sec_7.2.5.6
Section sec_7.2.5.7
Section sec_7.2.5.8
Section sec_7.2.6 <\/td>\n<\/tr>\n
31<\/td>\nSection sec_7.2.6.1
Section sec_7.2.6.2
Section sec_7.2.6.3 <\/td>\n<\/tr>\n
32<\/td>\nSection sec_7.2.7
Section sec_7.2.8
Section sec_7.2.9
Section sec_7.2.10 <\/td>\n<\/tr>\n
33<\/td>\nSection sec_7.3
Section sec_7.3.1
7.3\tPreclinical in vivo evaluation <\/td>\n<\/tr>\n
34<\/td>\nSection sec_7.3.2 <\/td>\n<\/tr>\n
35<\/td>\nSection sec_7.3.3 <\/td>\n<\/tr>\n
36<\/td>\nSection sec_7.4
Section sec_7.4.1
Section sec_7.4.2
7.4\tClinical investigations <\/td>\n<\/tr>\n
37<\/td>\nSection sec_7.4.3
Section sec_7.4.4
Section sec_7.4.5
Section sec_7.4.6
Section sec_7.4.7
Section sec_7.4.7.1 <\/td>\n<\/tr>\n
38<\/td>\nSection sec_7.4.7.2
Section sec_7.4.7.3 <\/td>\n<\/tr>\n
39<\/td>\nSection sec_7.4.7.4
Section sec_7.4.8
Section sec_7.4.8.1 <\/td>\n<\/tr>\n
40<\/td>\nSection sec_7.4.8.2
Section sec_7.4.8.3 <\/td>\n<\/tr>\n
41<\/td>\nAnnex sec_A
Annex sec_A.1
Annex sec_A.2
Annex\u00a0A
\n(informative)<\/p>\n

Rationale for the provisions of this part of ISO\u00a05840 <\/td>\n<\/tr>\n

42<\/td>\nAnnex sec_A.3
Annex sec_A.4
Annex sec_A.5 <\/td>\n<\/tr>\n
43<\/td>\nAnnex sec_A.6
Annex sec_A.7 <\/td>\n<\/tr>\n
44<\/td>\nAnnex sec_B
Annex sec_B.1
Figure fig_B.1
Annex\u00a0B
\n(informative)<\/p>\n

Examples of transcatheter heart valve substitutes, components and delivery systems <\/td>\n<\/tr>\n

45<\/td>\nFigure fig_B.2
Table tab_g
Figure fig_B.3 <\/td>\n<\/tr>\n
46<\/td>\nTable tab_h
Figure fig_B.4
Figure fig_B.5 <\/td>\n<\/tr>\n
47<\/td>\nTable tab_i
Figure fig_B.6
Annex sec_B.2
Figure fig_B.7 <\/td>\n<\/tr>\n
48<\/td>\nTable tab_j
Figure fig_B.8
Figure fig_B.9
Figure fig_B.10 <\/td>\n<\/tr>\n
49<\/td>\nFigure fig_B.11 <\/td>\n<\/tr>\n
50<\/td>\nAnnex sec_C
Annex sec_C.1
Annex sec_C.2
Annex sec_C.3
Annex sec_C.3.1
Annex sec_C.3.2
Annex\u00a0C
\n(normative)<\/p>\n

Packaging <\/td>\n<\/tr>\n

51<\/td>\nAnnex sec_D
Annex sec_D.1
Annex sec_D.1.1
Annex sec_D.1.2
Annex\u00a0D
\n(normative)<\/p>\n

Product labels, instructions for use and training <\/td>\n<\/tr>\n

52<\/td>\nAnnex sec_D.1.3 <\/td>\n<\/tr>\n
53<\/td>\nAnnex sec_D.1.4
Annex sec_D.2 <\/td>\n<\/tr>\n
54<\/td>\nAnnex sec_E
Annex sec_E.1
Annex\u00a0E
\n(normative)<\/p>\n

Sterilization <\/td>\n<\/tr>\n

55<\/td>\nAnnex sec_F
Annex sec_F.1
Annex sec_F.2
Annex sec_F.3
Annex\u00a0F
\n(informative)<\/p>\n

Valve description <\/td>\n<\/tr>\n

56<\/td>\nAnnex sec_F.4
Annex sec_F.5
Annex sec_F.6 <\/td>\n<\/tr>\n
57<\/td>\nAnnex sec_G
Annex sec_G.1
Table tab_G.1
Annex\u00a0G
\n(informative)<\/p>\n

Transcatheter heart valve substitute hazards, associated failure modes and evaluation methods <\/td>\n<\/tr>\n

58<\/td>\nAnnex sec_G.2 <\/td>\n<\/tr>\n
60<\/td>\nAnnex sec_G.3 <\/td>\n<\/tr>\n
61<\/td>\nAnnex sec_H
Annex sec_H.1
Table tab_H.1
Annex sec_H.2
Table tab_H.2
Annex sec_H.3
Annex\u00a0H
\n(informative)<\/p>\n

In vitro test guidelines for paediatric devices <\/td>\n<\/tr>\n

62<\/td>\nTable tab_H.3
Annex sec_H.4
Table tab_H.4
Annex sec_H.5
Table tab_H.5
Annex sec_H.6 <\/td>\n<\/tr>\n
63<\/td>\nTable tab_H.6
Annex sec_H.7
Table tab_H.7
Annex sec_H.8
Table tab_H.8
Annex sec_H.9 <\/td>\n<\/tr>\n
64<\/td>\nTable tab_H.9 <\/td>\n<\/tr>\n
65<\/td>\nAnnex sec_I
Annex sec_I.1
Annex sec_I.2
Annex\u00a0I
\n(informative)<\/p>\n

Statistical procedures when using performance criteria <\/td>\n<\/tr>\n

66<\/td>\nAnnex sec_J
Annex sec_J.1
Annex sec_J.2
Annex\u00a0J
\n(informative)<\/p>\n

Examples and definitions of some physical and material properties of transcatheter heart valve substitutes and their components <\/td>\n<\/tr>\n

67<\/td>\nAnnex sec_J.3
Annex sec_J.3.1 <\/td>\n<\/tr>\n
68<\/td>\nAnnex sec_J.4
Annex sec_J.4.1 <\/td>\n<\/tr>\n
72<\/td>\nAnnex sec_J.5 <\/td>\n<\/tr>\n
73<\/td>\nTable tab_k
Figure fig_J.1 <\/td>\n<\/tr>\n
75<\/td>\nTable tab_l
Figure fig_J.2 <\/td>\n<\/tr>\n
77<\/td>\nTable tab_m
Figure fig_J.3 <\/td>\n<\/tr>\n
79<\/td>\nAnnex sec_K
Annex sec_K.1
Annex\u00a0K
\n(informative)<\/p>\n

Examples of standards applicable to testing of materials and components of transcatheter heart valve substitutes <\/td>\n<\/tr>\n

81<\/td>\nAnnex sec_K.2 <\/td>\n<\/tr>\n
83<\/td>\nAnnex sec_K.3
Annex sec_K.4
Annex sec_K.5
Annex sec_K.6 <\/td>\n<\/tr>\n
85<\/td>\nAnnex sec_L
Annex sec_L.1
Annex sec_L.2
Annex sec_L.3
Annex\u00a0L
\n(informative)<\/p>\n

Raw and post-conditioning mechanical properties for support structure materials <\/td>\n<\/tr>\n

87<\/td>\nAnnex sec_M
Annex sec_M.1
Annex sec_M.2
Annex sec_M.3
Annex\u00a0M
\n(informative)<\/p>\n

Corrosion assessment <\/td>\n<\/tr>\n

88<\/td>\nAnnex sec_M.4
Annex sec_M.5
Annex sec_M.6 <\/td>\n<\/tr>\n
89<\/td>\nAnnex sec_M.7
Annex sec_M.8 <\/td>\n<\/tr>\n
90<\/td>\nAnnex sec_N
Annex sec_N.1
Annex sec_N.2
Annex sec_N.3
Annex sec_N.3.1
Annex sec_N.3.1.1
Annex sec_N.3.1.2
Annex sec_N.3.2
Annex sec_N.3.2.1
Annex sec_N.3.2.2
Annex sec_N.3.2.3
Annex sec_N.3.2.4
Annex sec_N.3.3
Annex sec_N.3.3.1
Annex\u00a0N
\n(informative)<\/p>\n

Guidelines for verification of hydrodynamic performance <\/td>\n<\/tr>\n

91<\/td>\nAnnex sec_N.3.4
Annex sec_N.4
Annex sec_N.4.1
Annex sec_N.4.1.1
Annex sec_N.4.1.2
Annex sec_N.4.1.3
Annex sec_N.4.2
Annex sec_N.4.2.1
Annex sec_N.4.2.2
Annex sec_N.4.2.3
Annex sec_N.4.2.4
Annex sec_N.4.2.5
Annex sec_N.4.2.6
Annex sec_N.4.2.7
Annex sec_N.4.3
Annex sec_N.4.3.1 <\/td>\n<\/tr>\n
92<\/td>\nAnnex sec_N.4.3.2
Annex sec_N.4.3.3
Annex sec_N.4.3.4
Annex sec_N.4.3.5
Annex sec_N.4.3.6
Annex sec_N.4.4 <\/td>\n<\/tr>\n
93<\/td>\nAnnex sec_N.4.5 <\/td>\n<\/tr>\n
94<\/td>\nAnnex sec_O
Annex sec_O.1
Annex sec_O.2
Annex sec_O.3
Annex sec_O.4
Annex\u00a0O
\n(informative)<\/p>\n

Durability testing <\/td>\n<\/tr>\n

95<\/td>\nAnnex sec_O.5
Annex sec_O.6
Annex sec_O.7 <\/td>\n<\/tr>\n
96<\/td>\nAnnex sec_P
Annex sec_P.1
Figure fig_P.1
Annex sec_P.2
Annex\u00a0P
\n(informative)<\/p>\n

Fatigue assessment <\/td>\n<\/tr>\n

98<\/td>\nAnnex sec_P.3
Annex sec_P.3.1
Annex sec_P.3.2 <\/td>\n<\/tr>\n
99<\/td>\nAnnex sec_P.3.3
Annex sec_P.3.4
Annex sec_P.3.5 <\/td>\n<\/tr>\n
100<\/td>\nAnnex sec_P.4
Annex sec_P.4.1
Annex sec_P.4.2
Annex sec_P.4.3
Annex sec_P.4.4 <\/td>\n<\/tr>\n
101<\/td>\nAnnex sec_P.4.5
Annex sec_P.4.6
Annex sec_P.4.7 <\/td>\n<\/tr>\n
102<\/td>\nAnnex sec_Q
Annex sec_Q.1
Annex sec_Q.2
Table tab_Q.1
Annex\u00a0Q
\n(informative)<\/p>\n

Preclinical in vivo evaluation <\/td>\n<\/tr>\n

103<\/td>\nAnnex sec_Q.3
Annex sec_Q.3.1
Annex sec_Q.3.2
Annex sec_Q.3.3
Annex sec_Q.3.4
Annex sec_Q.3.5
Annex sec_Q.3.6
Annex sec_Q.3.7 <\/td>\n<\/tr>\n
104<\/td>\nAnnex sec_Q.3.8
Annex sec_Q.3.9
Annex sec_Q.3.10 <\/td>\n<\/tr>\n
105<\/td>\nAnnex sec_R
Annex sec_R.1
Annex sec_R.2
Annex sec_R.3
Annex sec_R.4
Annex sec_R.5
Annex\u00a0R
\n(normative)<\/p>\n

Adverse event classification during clinical investigation <\/td>\n<\/tr>\n

106<\/td>\nAnnex sec_R.6
Annex sec_R.7
Annex sec_R.7.1
Annex sec_R.7.2 <\/td>\n<\/tr>\n
107<\/td>\nAnnex sec_R.8 <\/td>\n<\/tr>\n
108<\/td>\nTable tab_R.1 <\/td>\n<\/tr>\n
109<\/td>\nAnnex sec_R.9 <\/td>\n<\/tr>\n
110<\/td>\nAnnex sec_S
Annex sec_S.1
Annex sec_S.1.1
Annex sec_S.1.2
Annex sec_S.1.3
Annex sec_S.1.4
Annex sec_S.1.5
Annex sec_S.1.6
Annex sec_S.1.7
Annex sec_S.2
Annex sec_S.2.1
Annex\u00a0S
\n(informative)<\/p>\n

Echocardiographic protocol <\/td>\n<\/tr>\n

111<\/td>\nAnnex sec_S.2.2
Annex sec_S.2.3
Annex sec_S.3
Annex sec_S.3.1
Annex sec_S.3.2
Annex sec_S.3.3
Annex sec_S.3.4
Annex sec_S.3.5
Annex sec_S.3.6 <\/td>\n<\/tr>\n
112<\/td>\nAnnex sec_S.3.7
Annex sec_S.3.8
Annex sec_S.4 <\/td>\n<\/tr>\n
113<\/td>\nReference ref_1
Reference ref_2
Reference ref_3
Reference ref_4
Reference ref_5
Reference ref_6
Reference ref_7
Reference ref_8
Reference ref_9
Reference ref_10
Reference ref_11
Reference ref_12
Reference ref_13
Reference ref_14
Reference ref_15
Reference ref_16
Reference ref_17
Reference ref_18
Reference ref_19
Bibliography <\/td>\n<\/tr>\n
114<\/td>\nReference ref_20
Reference ref_21
Reference ref_22
Reference ref_23
Reference ref_24
Reference ref_25
Reference ref_26
Reference ref_27
Reference ref_28
Reference ref_29
Reference ref_30
Reference ref_31
Reference ref_32 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Cardiovascular implants. Cardiac valve prostheses – Heart valve substitutes implanted by transcatheter techniques<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2013<\/td>\n118<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":277644,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-277640","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\/277640","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\/277644"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=277640"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=277640"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=277640"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}