AAMI TIR59 2017

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AAMI TIR59:2017 – Integrating human factors into design controls

Published By	Publication Date	Number of Pages
AAMI	2017	37

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Category: AAMI

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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.

PDF Catalog

PDF Pages	PDF Title
1	AAMI TIR59:2017; Integrating human factors into design controls
3	Title page
4	AAMI Technical Information Report Copyright information
5	Contents
6	Glossary of equivalent standards
7	Committee representation
9	Foreword
10	Introduction
11	1 Scope
12	Figure 1: DESIGN CONTROLS and HFE/UE activity mapping
13	2 Terms and definitions
19	3 Acronyms 4 hfe/ue Integration within existing design controls
21	5 Pre design controls 6 Design controls—General [21 CFR 820.30(a)(1)]
22	7 Design and development planning [21 CFR 820.30 (b)]
23	8 Design input [CFR 820.30 (c)]
25	Table 1—Sources for generating user requirements
27	9 Design output—[21 CFR 820.30 (d)]
29	10 Design reviews—[21 CFR 820.30 (e)]
31	11 Design verification—[CFR 820.30 (f)] 12 Design validation—[21 CFR 820.30 (g)]
32	13 Design transfer—[CFR 820.30 (h)]
33	14 Design changes—[CFR 820.30 (i)]
34	15 design history file—[CFR 820.30 (j)] 16 post-market surveillance
35	Annex A (informative) HFE/UE report
37	Bibliography