AAMI HE48 : 1993

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Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES

Publisher: Association for the Advancement of Medical Instrumentation

Published: 01-01-1993

Available Formats: PDF - English - DRM, Hardcopy - English
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Table of Contents - (Show below) - (Hide below)

Foreword
1 Scope
2 Normative references
3 Definitions
4 Purpose
5 Human factors engineering process
6 General recommendations for human factors
engineering design
7 The human factor and the work space
8 Signs, symbols, and markings
9 Controls
10 Displays
11 Alarms and signals
12 User-computer interface
13 References
Annex 1 (Informative) - Bibliography

Abstract - (Show below) - (Hide below)

Describes the controls, displays, consoles, size, weight, and general user interface design of medical devices.

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Published
Document Type	Standard
Status	Superseded
Publisher	Association for the Advancement of Medical Instrumentation
Pages
ISBN
Committee	HE

Standards Referenced By This Book - (Show below) - (Hide below)

CSA C22.2 No. 60601.1.8 : 2008 : INC : AMD 1 : 2014(R2018)	MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
02/562586 DC : DRAFT JUN 2002	BS EN 60601-1-8 - MEDICAL ELECTRICAL EQUIPMENT - PART 8-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - ALARM SYSTEMS - REQUIREMENTS, TEST AND GUIDELINES - GENERAL REQUIREMENTS AND GUIDELINES FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND IN MEDICAL ELECTRICAL SYSTEMS
14/30244508 DC : 0	BS EN 62366-1 - MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
AAMI HE74 : 2001	HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES
15/30300279 DC : 0	BS ISO 80601-2-74 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-74: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT
CSA C22.2 No. 60601.1.8 : 2008	MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
CSA Z8185 : 2008	RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
04/30088533 DC : DRAFT MARCH 2004	BS EN ISO 8185 - RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
03/304741 DC : DRAFT APR 2003	IEC 60601-1-6 ED.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - USABILITY
BS EN 62366 : 2008	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
BS EN 62366-1 : 2015	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
AAMI IEC 62366 : 2015	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
CSA IEC 62366 : 2014	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
CSA C22.2 No. 60601.1.8 : 2008 : R2014	MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
AAMI HE74 : 2001 : R2009	HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES
CSA Z8185 : 2008(R2013)	RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
I.S. EN 62366-1:2015	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
I.S. EN 62366-1:2015	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
I.S. EN 62366-1:2015&AC:2015	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
I.S. EN 60601-1-8:2007	MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
BS EN 60601-1-8 : 2007	MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006)
CSA Z8185 : 2008 : R2013	RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
AAMI IEC 62366-1 : 2015	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
EN 60601-1-8 : 2007 AMD 11 2017	MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012)
CSA C22.2 No. 60601.1.8 : 2008(R2018)	MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
CSA IEC 62366-1 : 2015	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
AAMI IEC 60601-1-8 : 2006	MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
ASTM F 1452 : 2001	SPECIFICATION FOR MINIMUM PERFORMANCE AND SAFETY REQUIREMENTS FOR COMPONENTS AND SYSTEMS OF ANESTHETIC GAS MONITORS
ASTM F 1456 : 2001	SPECIFICATION FOR MINIMUM PERFORMANCE AND SAFETY REQUIREMENTS FOR CAPNOMETERS
I.S. EN 62366:2009	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
IEC 60601-1-8 : 2.1	MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
IEC 62366 : 1.1	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
IEC 62366-1 : 2015 COR 1 2016	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
DIN EN ISO 8185 E : 2009	RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
DIN EN ISO 8185 : 2009	RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
ISO 8185:2007(R2017)	RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
BS EN ISO 8185 : 2007	RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
AAMI HE74 : 2001	HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES
EN 62366-1 : 2015 COR 2015	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015)

Standards Referencing This Book - (Show below) - (Hide below)

MIL HDBK 759 : C	HANDBOOK FOR HUMAN ENGINEERING DESIGN GUIDELINES
MIL STD 1908 : 0	DEFINITION OF HUMAN FACTOR TERMS (METRIC)
DOD HDBK 743 : A	ANTHROPOMETRY OF U.S. MILITARY PERSONNEL (METRIC)
MIL STD 1472 : G	HUMAN ENGINEERING

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AAMI HE48 : 1993

Table of Contents - (Show below) - (Hide below)

Abstract - (Show below) - (Hide below)

General Product Information - (Show below) - (Hide below)

Standards Referenced By This Book - (Show below) - (Hide below)

Standards Referencing This Book - (Show below) - (Hide below)

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