{"id":198345,"date":"2024-10-19T12:37:35","date_gmt":"2024-10-19T12:37:35","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir80002-2-2017\/"},"modified":"2024-10-25T05:10:40","modified_gmt":"2024-10-25T05:10:40","slug":"aami-tir80002-2-2017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir80002-2-2017\/","title":{"rendered":"AAMI TIR80002 2 2017"},"content":{"rendered":"

This document applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.<\/p>\n

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1<\/td>\nAAMI\/ISO TIR80002-2:2017; Medical device software\u2014Part 2: Validation of software for medical device quality systems <\/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 Technical Report <\/td>\n<\/tr>\n
6<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
8<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nBackground of AAMI adoption of ISO TR 80002-2 <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
12<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references
3 Terms and definitions
4 Software validation discussion
4.1 Definition <\/td>\n<\/tr>\n
14<\/td>\n4.2 Confidence-building activities: Tools in the toolbox
4.3 Critical thinking
5 Software validation and critical thinking
5.1 Overview <\/td>\n<\/tr>\n
15<\/td>\nFigure 1\u2014Life-cycle controls <\/td>\n<\/tr>\n
17<\/td>\nFigure 2\u2014Life-cycle controls work stream <\/td>\n<\/tr>\n
18<\/td>\n5.2 Determine if the software is in scope
5.2.1 Document a high-level definition of the process and use of the software
5.2.2 Regulatory use assessment <\/td>\n<\/tr>\n
19<\/td>\n5.2.3 Processes and software extraneous to medical device regulatory requirements
5.3 Development phase
5.3.1 Validation planning
5.3.2 Define
5.3.2.1 Define block requirement <\/td>\n<\/tr>\n
20<\/td>\nFigure 3\u2014Life-cycle phase: Define block work streams
5.3.2.2 Process requirements <\/td>\n<\/tr>\n
21<\/td>\n5.3.2.3 Analysis of process failure risk
5.3.2.4 Validation planning
5.3.2.5 Software intended use
5.3.2.5.1 Elements of intended use <\/td>\n<\/tr>\n
22<\/td>\n5.3.2.5.2 Software purpose and intent
Table 1\u2014Sample questions and answers <\/td>\n<\/tr>\n
23<\/td>\n5.3.2.5.3 Software use requirements
5.3.2.5.4 Software requirements
5.3.3 Implement, test and deploy
5.3.3.1 Required activities <\/td>\n<\/tr>\n
24<\/td>\n5.3.3.2 Analysis of software failure risks
5.3.3.3 Validation planning
5.3.3.4 Software implementation (design, development, building and test) <\/td>\n<\/tr>\n
25<\/td>\nFigure 4\u2014Life-cycle phase: Implement, test and deploy block work streams
5.3.3.5 Validation report
5.3.3.6 Software release <\/td>\n<\/tr>\n
26<\/td>\n5.4 Maintain phase
5.4.1 Entering the maintenance phase
5.4.2 Planning for maintenance <\/td>\n<\/tr>\n
27<\/td>\n5.4.3 Types of maintenance within the maintain phase
5.4.4 Process changes: Change to risk control measures
5.4.5 Emergency change <\/td>\n<\/tr>\n
28<\/td>\n5.4.6 Maintaining for intended use
5.5 Retirement phase <\/td>\n<\/tr>\n
29<\/td>\n6 Documentation
7 Prerequisite processes <\/td>\n<\/tr>\n
31<\/td>\nAnnex A (informative) Toolbox
A.1 General
A.2 Toolbox structure
Table A.1\u2014Development phase: Define <\/td>\n<\/tr>\n
33<\/td>\nTable A.2\u2014Development phase: Implement <\/td>\n<\/tr>\n
34<\/td>\nTable A.3\u2014Development phase: Test <\/td>\n<\/tr>\n
36<\/td>\nTable A.4\u2014Development phase: Deploy
Table A.5\u2014Maintain phase <\/td>\n<\/tr>\n
38<\/td>\nAnnex B (informative) Risk management and risk-based approach
B.1 General
B.2 Terminology
B.3 Basic principle
B.4 Identification of hazardous situations and estimation risks <\/td>\n<\/tr>\n
40<\/td>\nB.5 Risk evaluation
B.6 Risk control
B.6.1 Unacceptable risk
B.6.2 Risk control measures not affecting the software <\/td>\n<\/tr>\n
41<\/td>\nB.6.3 Risk control measures affecting the software
B.6.4 Verification of risk control measures and evaluation of residual risk <\/td>\n<\/tr>\n
42<\/td>\nAnnex C (informative) Examples <\/td>\n<\/tr>\n
44<\/td>\nExample 1: Programmable logic controller (PLC) for manufacturing equipment <\/td>\n<\/tr>\n
48<\/td>\nExample 2: Automated welding system <\/td>\n<\/tr>\n
50<\/td>\nExample 3: Automated welding process control system <\/td>\n<\/tr>\n
51<\/td>\nTable C.1\u2014Example 3\u2014Process requirements <\/td>\n<\/tr>\n
52<\/td>\nTable C.2\u2014Example 3\u2014Analysis of process failure risk
Table C.3\u2014Example 3\u2014Software purpose and intent <\/td>\n<\/tr>\n
53<\/td>\nTable C.4\u2014Example 3\u2014Validation planning
Table C.5\u2014Example 3\u2014Software use requirements and software requirements <\/td>\n<\/tr>\n
54<\/td>\nTable C.6\u2014Example 3\u2014Analysis of software failure risks
Table C.7\u2014Example 3\u2014Validation planning <\/td>\n<\/tr>\n
55<\/td>\nTable C.8\u2014Example 3\u2014Software implementation
Table C.9\u2014Example 3\u2014Validation report
Table C.10\u2014Example 3\u2014Software release
Table C.11\u2014Example 3\u2014Analysis of change <\/td>\n<\/tr>\n
56<\/td>\nTable C.12\u2014Example 3\u2014Maintenance validation planning
Table C.13\u2014Example 3\u2014Software maintenance
Table C.14\u2014Example 3\u2014Retirement of software <\/td>\n<\/tr>\n
58<\/td>\nExample 4: C\/C++ language compiler
Figure C.1\u2014Implementation of class C medical device software <\/td>\n<\/tr>\n
62<\/td>\nExample 5: Automated software test system <\/td>\n<\/tr>\n
66<\/td>\nExample 6: A simple spreadsheet <\/td>\n<\/tr>\n
68<\/td>\nTable C.15\u2014Example 6\u2014Risks and mitigations <\/td>\n<\/tr>\n
70<\/td>\nExample 7: A (not so) simple spreadsheet <\/td>\n<\/tr>\n
74<\/td>\nExample 8: Parametric sterilizer <\/td>\n<\/tr>\n
78<\/td>\nExample 9: Nonconforming material reporting system\u2014Total system upgrade <\/td>\n<\/tr>\n
84<\/td>\nExample 10: Software for scheduling non-conforming material report (NCMR) review board meetings <\/td>\n<\/tr>\n
86<\/td>\nExample 11: Approved vendor list system <\/td>\n<\/tr>\n
90<\/td>\nExample 12: Calibration management software <\/td>\n<\/tr>\n
93<\/td>\nTable C.16\u2014Example 12\u2014Risk analysis <\/td>\n<\/tr>\n
95<\/td>\nTable C.17\u2014Example 12\u2014Risk evaluation and control <\/td>\n<\/tr>\n
103<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/ISO TIR80002-2:2017 – Medical device software-Part 2: Validation of software for medical device quality systems<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2017<\/td>\n103<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198346,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198345","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\/198345","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\/198346"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198345"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198345"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198345"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}