AAMI TIR59:2017
Current
The latest, up-to-date edition.
INTEGRATING HUMAN FACTORS INTO DESIGN CONTROLS
Hardcopy , PDF
English
04-08-2017
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Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Acronyms
4 HFE/UE Integration within existing
DESIGN CONTROLS
5 Pre DESIGN CONTROLS
6 DESIGN CONTROLS - General
[21 CFR 820.30(a)(1)]
7 Design and development planning
[21 CFR 820.30 (b)]
8 DESIGN INPUT [CFR 820.30 (c)]
9 DESIGN OUTPUT - [21 CFR 820.30 (d)]
10 Design reviews - [21 CFR 820.30 (e)]
11 Design VERIFICATION - [CFR 820.30 (f)]
12 Design VALIDATION - [21 CFR 820.30 (g)]
13 Design transfer - [CFR 820.30 (h)]
14 Design changes - [CFR 820.30 (i)]
15 DESIGN HISTORY FILE - [CFR 820.30 (j)]
16 POST-MARKET SURVEILLANCE
ANNEX A (INFORMATIVE) - HFE/UE report
Bibliography
This TIR was developed to provide background and information regarding HFE/UE activities and their corresponding applicability to DESIGN CONTROLS in accordance with 21 CFR 820.30.
| DocumentType |
Technical Report
|
| ISBN |
978-1-57020-666-5
|
| Pages |
37
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| ISO 9241-11:1998 | Ergonomic requirements for office work with visual display terminals (VDTs) Part 11: Guidance on usability |
| AAMI TIR50 : 2014 | POST-MARKET SURVEILLANCE OF USE ERROR MANAGEMENT |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| AAMI IEC 62366-1 : 2015 | MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| AAMI TIR51 : 2014 | HUMAN FACTORS ENGINEERING - GUIDANCE FOR CONTEXTUAL INQUIRY |
| ISO 9001:2015 | Quality management systems — Requirements |
| AAMI/IEC TIR62366-2:2016 | MEDICAL DEVICES - PART 2: GUIDANCE ON THE APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| AAMI/ISO 13485:2016 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
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