{"id":277775,"date":"2024-10-19T18:42:33","date_gmt":"2024-10-19T18:42:33","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-5841-22014\/"},"modified":"2024-10-25T15:13:51","modified_gmt":"2024-10-25T15:13:51","slug":"bs-iso-5841-22014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-5841-22014\/","title":{"rendered":"BS ISO 5841-2:2014"},"content":{"rendered":"

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.<\/p>\n

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.<\/p>\n

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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
6<\/td>\nForeword <\/td>\n<\/tr>\n
7<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\nSection sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.2
Section sec_3.3
1\tScope
2\tNormative references
3\tTerms and definitions <\/td>\n<\/tr>\n
10<\/td>\nSection 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 <\/td>\n<\/tr>\n
11<\/td>\nSection 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 <\/td>\n<\/tr>\n
12<\/td>\nSection 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 <\/td>\n<\/tr>\n
13<\/td>\nSection 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\tGeneral requirements
4.1\tFrequency of publication
4.2\tMethod of publication
4.3\tReport organization
4.4\tCriteria for inclusion and removal of reported models and device families
4.5\tSource of performance report data <\/td>\n<\/tr>\n
14<\/td>\nSection sec_4.6
Section sec_4.6.1
Section sec_4.6.2
4.6\tProduct performance report \u2014 Required content <\/td>\n<\/tr>\n
15<\/td>\nSection sec_4.6.2.1 <\/td>\n<\/tr>\n
16<\/td>\nSection sec_4.6.2.2
Section sec_4.7
Section sec_5
Section sec_5.1
4.7\tAdjustment for underreported events
5\tParticular reporting requirements
5.1\tReporting pulse generator performance <\/td>\n<\/tr>\n
17<\/td>\nSection sec_5.2
Section sec_5.2.1
Table tab_1
Section sec_5.2.2
5.2\tReporting lead performance <\/td>\n<\/tr>\n
18<\/td>\nTable tab_2
Section sec_5.2.3 <\/td>\n<\/tr>\n
19<\/td>\nSection sec_5.2.4
Section sec_5.2.4.1 <\/td>\n<\/tr>\n
20<\/td>\nTable tab_3 <\/td>\n<\/tr>\n
21<\/td>\nAnnex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_A.2.1
Annex sec_A.2.2
Annex\u00a0A
\n(normative)<\/p>\n

Statistical method for survival analysis and discussion of application of results obtained <\/td>\n<\/tr>\n

23<\/td>\nFigure fig_A.1
Annex sec_A.2.3
Annex sec_A.2.3.1 <\/td>\n<\/tr>\n
24<\/td>\nFigure fig_A.2 <\/td>\n<\/tr>\n
25<\/td>\nTable tab_A.1 <\/td>\n<\/tr>\n
26<\/td>\nAnnex sec_A.2.3.2
Figure fig_A.3 <\/td>\n<\/tr>\n
27<\/td>\nAnnex sec_A.3
Annex sec_A.3.1
Annex sec_A.3.2
Annex sec_A.3.3 <\/td>\n<\/tr>\n
30<\/td>\nAnnex sec_B
Annex sec_B.1
Annex sec_B.2
Annex\u00a0B
\n(informative)<\/p>\n

Rationale <\/td>\n<\/tr>\n

33<\/td>\nFigure fig_B.1
Figure fig_B.2 <\/td>\n<\/tr>\n
34<\/td>\nReference 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
Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Implants for surgery. Cardiac pacemakers – Reporting of clinical performance of populations of pulse generators or leads<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2014<\/td>\n38<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":277778,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-277775","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-40","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\/277775","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\/277778"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=277775"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=277775"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=277775"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}