{"id":198148,"date":"2024-10-19T12:36:51","date_gmt":"2024-10-19T12:36:51","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir80002-3-2016\/"},"modified":"2024-10-25T05:10:03","modified_gmt":"2024-10-25T05:10:03","slug":"aami-tir80002-3-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir80002-3-2016\/","title":{"rendered":"AAMI TIR80002 3 2016"},"content":{"rendered":"

Provides the description of software life cycle processes for medical devices. The medical device software life cycle processes are derived from IEC 62304:2006, with corresponding safety classes. They have been aligned with the software development life cycle processes of ISO\/IEC 12207:2008 and are presented herein in full compliance with ISO\/IEC 24774:2010.<\/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
1<\/td>\nAAMI\/IEC TIR80002-3:2016, Medical device software\u2014Part 3: Process reference model of medical device software life cycle processes (IEC 62304) <\/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 <\/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\/IEC TIR80002-3:2016 <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nIntroduction
0.1 Background
0.2 Organization of this technical report <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
16<\/td>\n4 Medical device software life cycle processes
4.1 Software development process
4.1.1 Software development planning
4.1.1.1 Purpose
4.1.1.2 Outcomes <\/td>\n<\/tr>\n
17<\/td>\n4.1.2 Software requirements analysis
4.1.2.1 Purpose
4.1.2.2 Outcomes
4.1.3 Software architectural design
4.1.3.1 Purpose
4.1.3.2 Outcomes <\/td>\n<\/tr>\n
18<\/td>\n4.1.4 Software detailed design
4.1.4.1 Purpose
4.1.4.2 Outcomes
4.1.5 Software unit implementation and verification
4.1.5.1 Purpose
4.1.5.2 Outcomes
4.1.6 Software integration and integration testing
4.1.6.1 Purpose
4.1.6.2 Outcomes <\/td>\n<\/tr>\n
19<\/td>\n4.1.7 Software system testing
4.1.7.1 Purpose
4.1.7.2 Outcomes
4.1.8 Software release
4.1.8.1 Purpose
4.1.8.2 Outcomes <\/td>\n<\/tr>\n
20<\/td>\n4.2 Software maintenance
4.2.1 Purpose
4.2.2 Outcomes
4.3 Software risk management
4.3.1 Purpose <\/td>\n<\/tr>\n
21<\/td>\n4.3.2 Outcomes
4.4 Software configuration management
4.4.1 Purpose
4.4.2 Outcomes <\/td>\n<\/tr>\n
22<\/td>\n4.5 Software problem resolution
4.5.1 Purpose
4.5.2 Outcomes <\/td>\n<\/tr>\n
24<\/td>\nAnnex A (informative) Development of this technical report
Figure A.1 \u2013 Requirements in process elements of IEC 62304:2006 and ISO\/IEC 12207:2008 <\/td>\n<\/tr>\n
25<\/td>\nFigure A.2 \u2013 Development of process outcomes for medical device software development PRM
Table A.1 \u2013 Direct process mappings between IEC 62304:2006 and ISO\/IEC 12207:2008 <\/td>\n<\/tr>\n
26<\/td>\nAnnex B (informative) Mapping between IEC 62304:2006 and ISO\/IEC 12207:2008 <\/td>\n<\/tr>\n
27<\/td>\nTable B.1 \u2013 Mapping between process outcomes of the PRM and the requirements of IEC 62304:2006, including their safety classes, and the requirements of ISO\/IEC 12207:2008 <\/td>\n<\/tr>\n
36<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/IEC TIR80002-3: 2016 – Technical Information Report Medical Device Software – Part 3: Process reference model of medical device software life cycle processes (IEC 62304)<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2016<\/td>\n36<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198154,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198148","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\/198148","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\/198154"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198148"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198148"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198148"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}