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BS EN ISO 5840-3:2013

BS EN ISO 5840-3:2013

$215.11

Cardiovascular implants. Cardiac valve prostheses – Heart valve substitutes implanted by transcatheter techniques

Published By Publication Date Number of Pages
BSI 2013 118
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PDF Catalog

PDF Pages PDF Title
5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC
9 Foreword
10 Introduction
11 Section sec_1
Section sec_2
1 Scope
2 Normative references
12 Section sec_3
3 Terms and definitions
14 Table tab_a
Figure fig_1
18 Table tab_c
Figure fig_2
20 Section sec_4
Section sec_5
Section sec_6
Section sec_6.1
Section sec_6.2
Section sec_6.2.1
4 Abbreviations
5 Fundamental requirements
6 Device description
6.1 Intended use
6.2 Design inputs
21 Table tab_1
Table tab_2
22 Section sec_6.2.2
Section sec_6.2.2.1
Section sec_6.2.2.2
23 Section 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 Design outputs
6.4 Design transfer (manufacturing verification/validation)
24 Section 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 Risk management
7 Design verification testing and analysis/design validation
7.1 General requirements
7.2 In vitro assessment
25 Section 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
26 Section sec_7.2.3
Table tab_3
27 Table tab_4
28 Section sec_7.2.4
Section sec_7.2.4.1
Section sec_7.2.4.2
29 Section sec_7.2.4.3
Section sec_7.2.5
Section sec_7.2.5.1
30 Section 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
31 Section sec_7.2.6.1
Section sec_7.2.6.2
Section sec_7.2.6.3
32 Section sec_7.2.7
Section sec_7.2.8
Section sec_7.2.9
Section sec_7.2.10
33 Section sec_7.3
Section sec_7.3.1
7.3 Preclinical in vivo evaluation
34 Section sec_7.3.2
35 Section sec_7.3.3
36 Section sec_7.4
Section sec_7.4.1
Section sec_7.4.2
7.4 Clinical investigations
37 Section 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
38 Section sec_7.4.7.2
Section sec_7.4.7.3
39 Section sec_7.4.7.4
Section sec_7.4.8
Section sec_7.4.8.1
40 Section sec_7.4.8.2
Section sec_7.4.8.3
41 Annex sec_A
Annex sec_A.1
Annex sec_A.2
Annex A
(informative)

Rationale for the provisions of this part of ISO 5840

42 Annex sec_A.3
Annex sec_A.4
Annex sec_A.5
43 Annex sec_A.6
Annex sec_A.7
44 Annex sec_B
Annex sec_B.1
Figure fig_B.1
Annex B
(informative)

Examples of transcatheter heart valve substitutes, components and delivery systems

45 Figure fig_B.2
Table tab_g
Figure fig_B.3
46 Table tab_h
Figure fig_B.4
Figure fig_B.5
47 Table tab_i
Figure fig_B.6
Annex sec_B.2
Figure fig_B.7
48 Table tab_j
Figure fig_B.8
Figure fig_B.9
Figure fig_B.10
49 Figure fig_B.11
50 Annex 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 C
(normative)

Packaging

51 Annex sec_D
Annex sec_D.1
Annex sec_D.1.1
Annex sec_D.1.2
Annex D
(normative)

Product labels, instructions for use and training

52 Annex sec_D.1.3
53 Annex sec_D.1.4
Annex sec_D.2
54 Annex sec_E
Annex sec_E.1
Annex E
(normative)

Sterilization

55 Annex sec_F
Annex sec_F.1
Annex sec_F.2
Annex sec_F.3
Annex F
(informative)

Valve description

56 Annex sec_F.4
Annex sec_F.5
Annex sec_F.6
57 Annex sec_G
Annex sec_G.1
Table tab_G.1
Annex G
(informative)

Transcatheter heart valve substitute hazards, associated failure modes and evaluation methods

58 Annex sec_G.2
60 Annex sec_G.3
61 Annex sec_H
Annex sec_H.1
Table tab_H.1
Annex sec_H.2
Table tab_H.2
Annex sec_H.3
Annex H
(informative)

In vitro test guidelines for paediatric devices

62 Table tab_H.3
Annex sec_H.4
Table tab_H.4
Annex sec_H.5
Table tab_H.5
Annex sec_H.6
63 Table tab_H.6
Annex sec_H.7
Table tab_H.7
Annex sec_H.8
Table tab_H.8
Annex sec_H.9
64 Table tab_H.9
65 Annex sec_I
Annex sec_I.1
Annex sec_I.2
Annex I
(informative)

Statistical procedures when using performance criteria

66 Annex sec_J
Annex sec_J.1
Annex sec_J.2
Annex J
(informative)

Examples and definitions of some physical and material properties of transcatheter heart valve substitutes and their components

67 Annex sec_J.3
Annex sec_J.3.1
68 Annex sec_J.4
Annex sec_J.4.1
72 Annex sec_J.5
73 Table tab_k
Figure fig_J.1
75 Table tab_l
Figure fig_J.2
77 Table tab_m
Figure fig_J.3
79 Annex sec_K
Annex sec_K.1
Annex K
(informative)

Examples of standards applicable to testing of materials and components of transcatheter heart valve substitutes

81 Annex sec_K.2
83 Annex sec_K.3
Annex sec_K.4
Annex sec_K.5
Annex sec_K.6
85 Annex sec_L
Annex sec_L.1
Annex sec_L.2
Annex sec_L.3
Annex L
(informative)

Raw and post-conditioning mechanical properties for support structure materials

87 Annex sec_M
Annex sec_M.1
Annex sec_M.2
Annex sec_M.3
Annex M
(informative)

Corrosion assessment

88 Annex sec_M.4
Annex sec_M.5
Annex sec_M.6
89 Annex sec_M.7
Annex sec_M.8
90 Annex 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 N
(informative)

Guidelines for verification of hydrodynamic performance

91 Annex 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
92 Annex 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
93 Annex sec_N.4.5
94 Annex sec_O
Annex sec_O.1
Annex sec_O.2
Annex sec_O.3
Annex sec_O.4
Annex O
(informative)

Durability testing

95 Annex sec_O.5
Annex sec_O.6
Annex sec_O.7
96 Annex sec_P
Annex sec_P.1
Figure fig_P.1
Annex sec_P.2
Annex P
(informative)

Fatigue assessment

98 Annex sec_P.3
Annex sec_P.3.1
Annex sec_P.3.2
99 Annex sec_P.3.3
Annex sec_P.3.4
Annex sec_P.3.5
100 Annex sec_P.4
Annex sec_P.4.1
Annex sec_P.4.2
Annex sec_P.4.3
Annex sec_P.4.4
101 Annex sec_P.4.5
Annex sec_P.4.6
Annex sec_P.4.7
102 Annex sec_Q
Annex sec_Q.1
Annex sec_Q.2
Table tab_Q.1
Annex Q
(informative)

Preclinical in vivo evaluation

103 Annex 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
104 Annex sec_Q.3.8
Annex sec_Q.3.9
Annex sec_Q.3.10
105 Annex sec_R
Annex sec_R.1
Annex sec_R.2
Annex sec_R.3
Annex sec_R.4
Annex sec_R.5
Annex R
(normative)

Adverse event classification during clinical investigation

106 Annex sec_R.6
Annex sec_R.7
Annex sec_R.7.1
Annex sec_R.7.2
107 Annex sec_R.8
108 Table tab_R.1
109 Annex sec_R.9
110 Annex 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 S
(informative)

Echocardiographic protocol

111 Annex 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
112 Annex sec_S.3.7
Annex sec_S.3.8
Annex sec_S.4
113 Reference 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
114 Reference 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

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BS EN ISO 5840-3:2013
$215.11