{"id":374209,"date":"2024-10-20T02:37:29","date_gmt":"2024-10-20T02:37:29","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir105-2020\/"},"modified":"2024-10-26T04:35:11","modified_gmt":"2024-10-26T04:35:11","slug":"aami-tir105-2020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir105-2020\/","title":{"rendered":"AAMI TIR105 2020"},"content":{"rendered":"

This technical information report provides recommendations and processes to assist manufacturers of combination products in identifying hazards associated with the combination product, assessing associated risks, selecting options for controlling these risks, and monitoring the effectiveness of the implemented controls.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI TIR105:2020; Risk management guidance for combination products <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Technical Information Report
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
1.1 Inclusions
1.2 Exclusions
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
12<\/td>\n4 Risk management plan
4.1 General considerations <\/td>\n<\/tr>\n
13<\/td>\n4.1.1 Description of combination product
4.1.2 Necessary expertise
4.2 Understanding of relevant standards and guidance
4.3 Integration of information from third-party vendors <\/td>\n<\/tr>\n
14<\/td>\n4.4 Consideration of supply risk
4.5 Documentation and record-keeping
5 Risk assessment
5.1 Risk profile and assessment approach
5.1.1 Establishing an overall safety profile <\/td>\n<\/tr>\n
15<\/td>\n5.1.2 Risk assessment inputs
Table 1\u2014Sources of input into risk assessment <\/td>\n<\/tr>\n
17<\/td>\n5.1.3 Risk assessment approach
5.1.3.1 System-level vs. constituent-part-level risk assessment
5.1.3.2 Risk analysis tools
5.1.3.3 Documentation <\/td>\n<\/tr>\n
18<\/td>\n5.2 Risk analysis
5.2.1 Integrated risk analysis
5.2.2 Hazard assessment and example of constituent contributions
Table 2\u2014Sample system-level risk assessment <\/td>\n<\/tr>\n
19<\/td>\nTable 3\u2014How individual risk analyses can be incorporated into a system-level risk analysis
5.2.3 Identification and understanding of events
Table 4\u2014Example of how one constituent\u2019s failure can affect the other <\/td>\n<\/tr>\n
20<\/td>\n5.2.4 Initial control effects
5.2.5 Proper definition of harm
Table 5\u2014Defining harm appropriately
5.2.5.1 Use of a \u201csurrogate approach\u201d
Figure 1\u2014Event chain <\/td>\n<\/tr>\n
21<\/td>\n5.2.6 Resources and terminology
5.3 Risk evaluation
5.4 Risk analysis <\/td>\n<\/tr>\n
22<\/td>\n6 Risk control
Table 6\u2014Approaches to risk control <\/td>\n<\/tr>\n
24<\/td>\n7 Risk management report
8 Risk review monitoring
8.1 General considerations <\/td>\n<\/tr>\n
25<\/td>\nFigure 2\u2014Risk review
8.2 Risk review initiators and their evaluation <\/td>\n<\/tr>\n
26<\/td>\n8.3 Review of risk management activities and documentation <\/td>\n<\/tr>\n
27<\/td>\nAnnex A (informative) Summary of requirements of ISO 14971, ICH Q9, and AAMI TIR48
Table A.1\u2014Risk management plan
Table A.2\u2014Risk assessment <\/td>\n<\/tr>\n
29<\/td>\nTable A.3\u2014Risk control <\/td>\n<\/tr>\n
30<\/td>\nTable A.4\u2014Risk report <\/td>\n<\/tr>\n
31<\/td>\nTable A.5\u2014Risk review\/monitoring <\/td>\n<\/tr>\n
33<\/td>\nAnnex B (informative) Combination product risk management utilizing a risk traceability summary <\/td>\n<\/tr>\n
34<\/td>\nFigure B.1\u2014Risk assessment trace matrix <\/td>\n<\/tr>\n
35<\/td>\nFigure B.2\u2014Tools and techniques used during the design process to perform risk analysis <\/td>\n<\/tr>\n
36<\/td>\nFigure B.3\u2014Streamlined risk management trace matrix <\/td>\n<\/tr>\n
37<\/td>\nTable B.1\u2014Risk management traceability
Table B.2\u2014Risk management traceability (page 2) <\/td>\n<\/tr>\n
39<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI TIR105:2020 Risk management guidance for combination products<\/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":374216,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-374209","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\/374209","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\/374216"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=374209"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=374209"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=374209"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}