{"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 Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1. Scope
2. Normative references
3. Terms and definitions <\/td>\n<\/tr>\n
12<\/td>\n4. Purpose of post-market surveillance process <\/td>\n<\/tr>\n
15<\/td>\n5. Planning of post-market surveillance
5.1 General
5.2 Scope of the post-market surveillance plan <\/td>\n<\/tr>\n
16<\/td>\n5.3 Objective of the post-market surveillance plan <\/td>\n<\/tr>\n
18<\/td>\n5.4 Responsibilities and authorities <\/td>\n<\/tr>\n
19<\/td>\n5.5 Data collection
5.5.1 Data sources <\/td>\n<\/tr>\n
20<\/td>\n5.5.2 Defining data collection methods <\/td>\n<\/tr>\n
21<\/td>\n5.5.3 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>\n5.6.3 Methods for data analysis <\/td>\n<\/tr>\n
23<\/td>\n5.7 Report on data analysis <\/td>\n<\/tr>\n
24<\/td>\n5.8 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>\n6.3 Review <\/td>\n<\/tr>\n
26<\/td>\nAnnex A (informative) Examples of data sources <\/td>\n<\/tr>\n
40<\/td>\nAnnex B (informative) Examples of data analysis methods
B.1 General
B.2 Overview table: data analysis methods <\/td>\n<\/tr>\n
41<\/td>\nB.3 Descriptive methods for trend analysis <\/td>\n<\/tr>\n
43<\/td>\nB.4 Descriptive method: Bar charts
B.5 Descriptive method Pareto <\/td>\n<\/tr>\n
44<\/td>\nB.6 Qualitative techniques <\/td>\n<\/tr>\n
45<\/td>\nAnnex 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>\nC.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>\nC.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>\nC.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>\nC.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>\nC.3.6 Data analysis <\/td>\n<\/tr>\n
52<\/td>\nC.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>\nC.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>\nC.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>\nC.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>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

PD ISO\/TR 20416. Medical devices. Post-market surveillance for manufacturers<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2019<\/td>\n56<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":341779,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,2641],"product_tag":[],"class_list":{"0":"post-341773","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-01","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/341773","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/341779"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=341773"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=341773"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=341773"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}