{"id":341773,"date":"2024-10-19T23:58:12","date_gmt":"2024-10-19T23:58:12","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-19-30401776-dc\/"},"modified":"2024-10-25T23:11:23","modified_gmt":"2024-10-25T23:11:23","slug":"bsi-19-30401776-dc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-19-30401776-dc\/","title":{"rendered":"BSI 19\/30401776 DC"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | 1. Scope 2. Normative references 3. Terms and definitions <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | 4. Purpose of post-market surveillance process <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 5. Planning of post-market surveillance 5.1 General 5.2 Scope of the post-market surveillance plan <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 5.3 Objective of the post-market surveillance plan <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | 5.4 Responsibilities and authorities <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | 5.5 Data collection 5.5.1 Data sources <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | 5.5.2 Defining data collection methods <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | 5.6.3 Methods for data analysis <\/td>\n<\/tr>\n | ||||||
23<\/td>\n | 5.7 Report on data analysis <\/td>\n<\/tr>\n | ||||||
24<\/td>\n | 5.8 Interface with other processes 6. Review of the post-market surveillance plan 6.1 Purpose of the review 6.2 Criteria <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | 6.3 Review <\/td>\n<\/tr>\n | ||||||
26<\/td>\n | Annex A (informative) Examples of data sources <\/td>\n<\/tr>\n | ||||||
40<\/td>\n | Annex B (informative) Examples of data analysis methods B.1 General B.2 Overview table: data analysis methods <\/td>\n<\/tr>\n | ||||||
41<\/td>\n | B.3 Descriptive methods for trend analysis <\/td>\n<\/tr>\n | ||||||
43<\/td>\n | B.4 Descriptive method: Bar charts B.5 Descriptive method Pareto <\/td>\n<\/tr>\n | ||||||
44<\/td>\n | B.6 Qualitative techniques <\/td>\n<\/tr>\n | ||||||
45<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
46<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
47<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
49<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
50<\/td>\n | C.3.3 Objective of the post-market surveillance plan C.3.4 Responsibilities and authorities C.3.5 Data collection <\/td>\n<\/tr>\n | ||||||
51<\/td>\n | C.3.6 Data analysis <\/td>\n<\/tr>\n | ||||||
52<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
53<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
54<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
55<\/td>\n | C.5.6 Data analysis C.5.7 Report on data analysis C.5.8 Review of the post-market surveillance plan <\/td>\n<\/tr>\n | ||||||
56<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" PD ISO\/TR 20416. Medical devices. Post-market surveillance for manufacturers<\/b><\/p>\n |