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BS ISO 5841-2:2014 Implants for surgery. Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads >
BS ISO 5841-2:2014 Implants for surgery. Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads, 2014
- Section sec_1
- Section sec_2
- Section sec_3
- Section sec_3.1
- Section sec_3.2
- Section sec_3.3
- 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
- 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
- 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
- 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
- Section sec_4.6
- Section sec_4.6.1
- Section sec_4.6.2
- Section sec_4.6.2.1
- Section sec_4.6.2.2
- Section sec_4.7
- Section sec_5
- Section sec_5.1
- Section sec_5.2
- Section sec_5.2.1
- Table tab_1
- Section sec_5.2.2
- Table tab_2
- Section sec_5.2.3
- Section sec_5.2.4
- Section sec_5.2.4.1
- Table tab_3
- Annex sec_A
- Annex sec_A.1
- Annex sec_A.2
- Annex sec_A.2.1
- Annex sec_A.2.2
- Figure fig_A.1
- Annex sec_A.2.3
- Annex sec_A.2.3.1
- Figure fig_A.2
- Table tab_A.1
- Annex sec_A.2.3.2
- Figure fig_A.3
- Annex sec_A.3
- Annex sec_A.3.1
- Annex sec_A.3.2
- Annex sec_A.3.3
- Annex sec_B
- Annex sec_B.1
- Annex sec_B.2
- Figure fig_B.1
- Figure fig_B.2
- 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
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 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
- 4.6 Product performance report — Required content
- 4.7 Adjustment for underreported events
- 5 Particular reporting requirements
- 5.1 Reporting pulse generator performance
- 5.2 Reporting lead performance
- Annex A (normative) Statistical method for survival analysis and discussion of application of results obtained
- Annex B (informative) Rationale
- Bibliography [Go to Page]