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BS ISO 5841-2:2014

BS ISO 5841-2:2014

$167.15

Implants for surgery. Cardiac pacemakers – Reporting of clinical performance of populations of pulse generators or leads

Published By Publication Date Number of Pages
BSI 2014 38
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This part of ISO 5841 specifies requirements for reports on the clinical performance in humans of population samples of cardiac pulse generators or leads, intended for long-term implantation, hereinafter referred to as devices. Devices to be reported has to be market approved in one or more geographies. It includes general requirements for all reports and supplementary requirements for reports on cumulative experience with devices and estimates of future clinical performance for devices, when appropriate.

Annex A provides requirements for categorizing devices. It also provides normative requirements for statistical calculations, including a discussion of application of the results obtained. As with other statistical methods, the benefit of the analytical methods in this part of ISO 5841 is limited by the size of population under consideration. Annex B gives the rationale for this part of ISO 5841.

PDF Catalog

PDF Pages PDF Title
6 Foreword
7 Introduction
9 Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.2
Section sec_3.3
1 Scope
2 Normative references
3 Terms and definitions
10 Section sec_3.4
Section sec_3.5
Section sec_3.6
Section sec_3.7
Section sec_3.8
Section sec_3.9
Section sec_3.10
Section sec_3.11
Section sec_3.12
Section sec_3.13
Section sec_3.14
11 Section sec_3.15
Section sec_3.16
Section sec_3.17
Section sec_3.18
Section sec_3.19
Section sec_3.20
Section sec_3.21
12 Section sec_3.22
Section sec_3.23
Section sec_3.24
Section sec_3.25
Section sec_3.26
Section sec_3.27
Section sec_3.28
Section sec_3.29
Section sec_3.30
Section sec_3.31
13 Section sec_3.32
Section sec_3.33
Section sec_3.34
Section sec_3.35
Section sec_3.36
Section sec_4
Section sec_4.1
Section sec_4.2
Section sec_4.3
Section sec_4.4
Section sec_4.5
4 General requirements
4.1 Frequency of publication
4.2 Method of publication
4.3 Report organization
4.4 Criteria for inclusion and removal of reported models and device families
4.5 Source of performance report data
14 Section sec_4.6
Section sec_4.6.1
Section sec_4.6.2
4.6 Product performance report — Required content
15 Section sec_4.6.2.1
16 Section sec_4.6.2.2
Section sec_4.7
Section sec_5
Section sec_5.1
4.7 Adjustment for underreported events
5 Particular reporting requirements
5.1 Reporting pulse generator performance
17 Section sec_5.2
Section sec_5.2.1
Table tab_1
Section sec_5.2.2
5.2 Reporting lead performance
18 Table tab_2
Section sec_5.2.3
19 Section sec_5.2.4
Section sec_5.2.4.1
20 Table tab_3
21 Annex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_A.2.1
Annex sec_A.2.2
Annex A
(normative)

Statistical method for survival analysis and discussion of application of results obtained

23 Figure fig_A.1
Annex sec_A.2.3
Annex sec_A.2.3.1
24 Figure fig_A.2
25 Table tab_A.1
26 Annex sec_A.2.3.2
Figure fig_A.3
27 Annex sec_A.3
Annex sec_A.3.1
Annex sec_A.3.2
Annex sec_A.3.3
30 Annex sec_B
Annex sec_B.1
Annex sec_B.2
Annex B
(informative)

Rationale

33 Figure fig_B.1
Figure fig_B.2
34 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
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Reference ref_15
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Bibliography

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BS ISO 5841-2:2014
$167.15