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BSI 19/30401776 DC:2019 Edition

BSI 19/30401776 DC:2019 Edition

$13.70

PD ISO/TR 20416. Medical devices. Post-market surveillance for manufacturers

Published By Publication Date Number of Pages
BSI 2019 56
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PDF Catalog

PDF Pages PDF Title
7 Foreword
8 Introduction
11 1. Scope
2. Normative references
3. Terms and definitions
12 4. Purpose of post-market surveillance process
15 5. Planning of post-market surveillance
5.1 General
5.2 Scope of the post-market surveillance plan
16 5.3 Objective of the post-market surveillance plan
18 5.4 Responsibilities and authorities
19 5.5 Data collection
5.5.1 Data sources
20 5.5.2 Defining data collection methods
21 5.5.3 Developing the data collection protocol
5.6 Data analysis
5.6.1 General
5.6.2 Considerations concerning planning the data analysis
22 5.6.3 Methods for data analysis
23 5.7 Report on data analysis
24 5.8 Interface with other processes
6. Review of the post-market surveillance plan
6.1 Purpose of the review
6.2 Criteria
25 6.3 Review
26 Annex A (informative) Examples of data sources
40 Annex B (informative) Examples of data analysis methods
B.1 General
B.2 Overview table: data analysis methods
41 B.3 Descriptive methods for trend analysis
43 B.4 Descriptive method: Bar charts
B.5 Descriptive method Pareto
44 B.6 Qualitative techniques
45 Annex C (informative) Examples of post-market surveillance plans
C.1 Example of a post-market surveillance plan for a surgical scalpel
C.1.1 General
C.1.2 Scope of the post-market surveillance plan
C.1.3 Objective of the post-market surveillance plan
C.1.4 Responsibilities and authorities
C.1.5 Data collection
46 C.1.6 Data analysis
C.1.7 Report on data analysis
C.1.8 Review of the post-market surveillance plan
C.2 Example of a post-market surveillance plan for a radiation therapy system
C.2.1 General
47 C.2.2 Scope of the post-market surveillance plan
C.2.3 Objective of the post-market surveillance plan
C.2.4 Responsibilities and authorities
C.2.5 Data collection
49 C.2.6 Data analysis
C.2.7 Report on data analysis
C.2.8 Review of the post-market surveillance plan
C.3 Example of a post-market surveillance plan for a drug eluting stent
C.3.1 General
C.3.2 Scope of the post-market surveillance plan
50 C.3.3 Objective of the post-market surveillance plan
C.3.4 Responsibilities and authorities
C.3.5 Data collection
51 C.3.6 Data analysis
52 C.3.7 Report on data analysis
C.3.8 Review of the post-market surveillance plan
C.4 Example of a post-market surveillance plan for a blood glucose monitoring system
C.4.1 General
C.4.2 Scope of the post-market surveillance plan
C.4.3 Objective of the post-market surveillance plan
C.4.4 Responsibilities and authorities
53 C.4.5 Data collection
C.4.6 Data analysis
C.4.7 Report on data analysis
C.4.8 Review of the post-market surveillance plan
C.5 Example for IVD large analyser
C.5.1 General
54 C.5.2 Scope of the post-market surveillance plan
C.5.3 Objective of the post-market surveillance plan
C.5.4 Responsibilities and authorities
C.5.5 Data collection
55 C.5.6 Data analysis
C.5.7 Report on data analysis
C.5.8 Review of the post-market surveillance plan
56 Bibliography

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BSI 19/30401776 DC
$13.70