{"id":198142,"date":"2024-10-19T12:36:50","date_gmt":"2024-10-19T12:36:50","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir59-2017\/"},"modified":"2024-10-25T05:10:01","modified_gmt":"2024-10-25T05:10:01","slug":"aami-tir59-2017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir59-2017\/","title":{"rendered":"AAMI TIR59 2017"},"content":{"rendered":"

This document provides information regarding human factors engineering\/usability engineering activities and their corresponding applicability to design controls in accordance with 21 CFR 820.30.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI TIR59:2017; Integrating human factors into design controls <\/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>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1 Scope <\/td>\n<\/tr>\n
12<\/td>\nFigure 1: DESIGN CONTROLS and HFE\/UE activity mapping <\/td>\n<\/tr>\n
13<\/td>\n2 Terms and definitions <\/td>\n<\/tr>\n
19<\/td>\n3 Acronyms
4 hfe\/ue Integration within existing design controls <\/td>\n<\/tr>\n
21<\/td>\n5 Pre design controls
6 Design controls\u2014General [21 CFR 820.30(a)(1)] <\/td>\n<\/tr>\n
22<\/td>\n7 Design and development planning [21 CFR 820.30 (b)] <\/td>\n<\/tr>\n
23<\/td>\n8 Design input [CFR 820.30 (c)] <\/td>\n<\/tr>\n
25<\/td>\nTable 1\u2014Sources for generating user requirements <\/td>\n<\/tr>\n
27<\/td>\n9 Design output\u2014[21 CFR 820.30 (d)] <\/td>\n<\/tr>\n
29<\/td>\n10 Design reviews\u2014[21 CFR 820.30 (e)] <\/td>\n<\/tr>\n
31<\/td>\n11 Design verification\u2014[CFR 820.30 (f)]
12 Design validation\u2014[21 CFR 820.30 (g)] <\/td>\n<\/tr>\n
32<\/td>\n13 Design transfer\u2014[CFR 820.30 (h)] <\/td>\n<\/tr>\n
33<\/td>\n14 Design changes\u2014[CFR 820.30 (i)] <\/td>\n<\/tr>\n
34<\/td>\n15 design history file\u2014[CFR 820.30 (j)]\u00a0
16 post-market surveillance <\/td>\n<\/tr>\n
35<\/td>\nAnnex A (informative) HFE\/UE report <\/td>\n<\/tr>\n
37<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI TIR59:2017 – Integrating human factors into design controls<\/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>\n37<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198145,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198142","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\/198142","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\/198145"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198142"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198142"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198142"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}