INTEGRATING HUMAN FACTORS INTO DESIGN CONTROLS

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-04-2017

Publisher

Association for the Advancement of Medical Instrumentation

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