{"id":374212,"date":"2024-10-20T02:37:30","date_gmt":"2024-10-20T02:37:30","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir20416-2020\/"},"modified":"2024-10-26T04:35:12","modified_gmt":"2024-10-26T04:35:12","slug":"aami-tir20416-2020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir20416-2020\/","title":{"rendered":"AAMI TIR20416 2020"},"content":{"rendered":"

The is an adoption of AAMI\/ISO TIR 20416<\/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\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
1<\/td>\nAAMI\/ISO TIR20416:2020; Medical devices\u2014Post-market surveillance for manufacturers <\/td>\n<\/tr>\n
2<\/td>\nBlank Page <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nCopyright information <\/td>\n<\/tr>\n
5<\/td>\nAAMI Technical Information Report
ANSI Registration <\/td>\n<\/tr>\n
6<\/td>\nContents Page <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nBackground of AAMI adoption of ISO TR 20416 Ed.1. <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\nFigure 1 \u2014 Inter-relationship of ISO TR 20416 with ISO 13485 and ISO 14971 standards <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
14<\/td>\n4 Purpose of post-market surveillance process <\/td>\n<\/tr>\n
15<\/td>\nFigure 2 \u2014 Example schematic representation of post-market surveillance <\/td>\n<\/tr>\n
16<\/td>\n5 Planning of post-market surveillance
5.1 General
5.2 Scope of the post-market surveillance plan <\/td>\n<\/tr>\n
17<\/td>\n5.3 Objective of the post-market surveillance plan <\/td>\n<\/tr>\n
18<\/td>\nTable 1 \u2014 Examples of post-market surveillance plan objectives. <\/td>\n<\/tr>\n
19<\/td>\n5.4 Responsibilities and authorities
Table 2 \u2014 Example of post-market surveillance resources allocation matrix. <\/td>\n<\/tr>\n
20<\/td>\n5.5 Data collection
5.5.1 Data sources
5.5.2 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 <\/td>\n<\/tr>\n
22<\/td>\n5.6.2 Considerations concerning planning the data analysis
5.6.3 Methods for data analysis
Table 3 \u2014 Examples of the objective and appropriate data analysis methods <\/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
Table A.1 \u2014 Examples of data sources that can be used for post-market surveillance activities <\/td>\n<\/tr>\n
36<\/td>\nAnnex B (informative) Examples of data analysis methods
B.1 General
B.2 Overview table: data analysis methods <\/td>\n<\/tr>\n
37<\/td>\nTable B.1 \u2014 Examples of data sources and suggested methods for data analysis
B.3 Descriptive methods for trend analysis <\/td>\n<\/tr>\n
38<\/td>\nFigure B.1 \u2014 Examples of types of changes identified using trend analysis <\/td>\n<\/tr>\n
39<\/td>\nFigure B.2 \u2014 Trending of monthly complaint rate
B.4 Descriptive method: Bar charts <\/td>\n<\/tr>\n
40<\/td>\nFigure B.3 \u2014 Bar chart showing the number of reported complaints for three medical device variants 1, 2 and 3
B.5 Descriptive method, Pareto analysis <\/td>\n<\/tr>\n
41<\/td>\nFigure B.4 \u2014 Pareto diagram for complaint causes for implant instruments (product family)
B.6 Qualitative techniques <\/td>\n<\/tr>\n
43<\/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 <\/td>\n<\/tr>\n
44<\/td>\nC.1.5 Data collection
C.1.6 Data analysis
C.1.7 Report on data analysis <\/td>\n<\/tr>\n
45<\/td>\nC.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
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 <\/td>\n<\/tr>\n
46<\/td>\nC.2.5 Data collection
Table C.1 \u2014 Data collection and data analysis activities <\/td>\n<\/tr>\n
47<\/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
48<\/td>\nC.3.3 Objective of the post-market surveillance plan
C.3.4 Responsibilities and authorities
C.3.5 Data collection
C.3.5.1 Passive\/reactive feedback
C.3.5.2 Proactive feedback <\/td>\n<\/tr>\n
49<\/td>\nC.3.6 Data analysis
C.3.6.1 General
C.3.6.2 Post-market clinical follow-up studies <\/td>\n<\/tr>\n
50<\/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
C.4.5 Data collection <\/td>\n<\/tr>\n
51<\/td>\nC.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 large IVD analyser
C.5.1 General
C.5.2 Scope of the post-market surveillance plan <\/td>\n<\/tr>\n
52<\/td>\nC.5.3 Objective of the post-market surveillance plan
C.5.4 Responsibilities and authorities
C.5.5 Data collection <\/td>\n<\/tr>\n
53<\/td>\nC.5.6 Data analysis
C.5.7 Report on data analysis <\/td>\n<\/tr>\n
54<\/td>\nC.5.8 Review of the post-market surveillance plan <\/td>\n<\/tr>\n
55<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/ISO TIR20416:2020, 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
AAMI<\/b><\/a><\/td>\n2020<\/td>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":374220,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-374212","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/374212","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\/374220"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=374212"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=374212"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=374212"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}