AAMI HE75 : 2009(R2013)

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Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - DESIGN OF MEDICAL DEVICES

Publisher: Association for the Advancement of Medical Instrumentation

Published: 08-10-2018

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

Glossary of equivalent standards
Committee representation
Acknowledgments
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions and abbreviations
General Considerations and Principles
4 General principles
5 Managing the risk of use error
6 Basic human skills and abilities
7 Anthropometry and biomechanics
8 Environmental considerations
9 Usability testing
10 Signs, symbols, and markings
11 User documentation
12 Packaging design
13 Design for post-market issues
14 Cross-cultural/cross-national design
15 Alarm design
16 Accessibility considerations
Design Elements
17 Connectors and connections
18 Controls
19 Visual displays
20 Use of automation
21 Software-user interfaces
Integrated Solutions
22 Hand tool design
23 Workstations
24 Design of mobile medical devices
25 Home health care
Annexes
A Statistical justification for sample sizes in
usability testing

Abstract - (Show below) - (Hide below)

Specifies a broad range of human factors engineering (HFE) topics in a structured format.

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Published
Document Type	Revision
Status	Superseded
Publisher	Association for the Advancement of Medical Instrumentation
ProductNote	Reconfirmed 2013 PDF has been updated Price has been updated
Pages
ISBN
Committee	HE
Superseded By	ANSI/AAMI HE75:2009/(R)2018

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

ISO 9241-11 : 1998	ERGONOMICS OF HUMAN-SYSTEM INTERACTION - PART 11: USABILITY: DEFINITIONS AND CONCEPTS
ISO 9186 : 2001	GRAPHICAL SYMBOLS - TEST METHODS FOR JUDGED COMPREHENSIBILITY AND FOR COMPREHENSION
IEC 60245-1 : 4.1	RUBBER INSULATED CABLES - RATED VOLTAGES UP TO AND INCLUDING 450/750 V - PART 1: GENERAL REQUIREMENTS
IEC 60601-1-11 : 2.0EN+(REDLINE+VERSION)	MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT
ANSI S12-2 : 2008	CRITERIA FOR EVALUATING ROOM NOISE
ASTM D 4169 : 2016 : REDLINE	Standard Practice for Performance Testing of Shipping Containers and Systems
ISO 68-2 : 1998(R2014)	ISO GENERAL PURPOSE SCREW THREADS - BASIC PROFILE - PART 2: INCH SCREW THREADS
AAMI ES60601-1 : 2005	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
ISO 15223-2 : 2010	Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
ISO 9703-1 : 1992	ANAESTHESIA AND RESPIRATORY CARE ALARM SIGNALS - PART 1: VISUAL ALARM SIGNALS
IEC 60601-1:2005+AMD1:2012 CSV	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
AAMI ISO 14937 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
MIL HDBK 759 : C	HANDBOOK FOR HUMAN ENGINEERING DESIGN GUIDELINES
IEEE 802.15.4 : 2011	LOW-RATE WIRELESS PERSONAL AREA NETWORKS (WPANS)
AAMI ISO 15223-1 : 2016	MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
ISO TR 18529 : 2000(R2004)	ERGONOMICS - ERGONOMICS OF HUMAN-SYSTEM INTERACTION - HUMAN-CENTRED LIFECYCLE PROCESS DESCRIPTIONS
IEC 60601-1-10 : 1.1	MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
CFR 21(PTS800-1299) : 0	FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
IEEE 802.11 : 2016	INFORMATION TECHNOLOGY - TELECOMMUNICATIONS AND INFORMATION EXCHANGE BETWEEN SYSTEMS LOCAL AND METROPOLITAN AREA NETWORKS - SPECIFIC REQUIREMENTS
ISO 9241-7 : 1998	ERGONOMIC REQUIREMENTS FOR OFFICE WORK WITH VISUAL DISPLAY TERMINALS (VDTS) - PART 7: REQUIREMENTS FOR DISPLAY WITH REFLECTIONS
ANSI INCITS 354 : 2001	INFORMATION TECHNOLOGY - COMMON INDUSTRY FORMAT FOR USABILITY TEST REPORTS
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
ANSI S3.34 : 0	GUIDE FOR THE MEASUREMENT AND EVALUATION OF HUMAN EXPOSURE TO VIBRATION TRANSMITTED TO THE HAND
CGA C 9 : 2013	STANDARD COLOR MARKING OF COMPRESSED GAS CONTAINERS FOR MEDICAL USE
AAMI IEC TIR 60878 : 2003	GRAPHICAL SYMBOLS FOR ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE
IEC 62366 : 1.1	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
IEC 60227-1 : 2007	POLYVINYL CHLORIDE INSULATED CABLES OF RATED VOLTAGES UP TO AND INCLUDING 450/750 V - PART 1: GENERAL REQUIREMENTS
DEFSTAN 00-25(PT19)/1(2004) : 2004	HUMAN FACTORS FOR DESIGNERS OF SYSTEMS - PART 19: HUMAN ENGINEERING DOMAIN
ISO 32 : 1977(R2017)	GAS CYLINDERS FOR MEDICAL USE - MARKING FOR IDENTIFICATION OF CONTENT
IEC 60601-1-2 : 4.0	MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
ISO 216 : 2007(R2016)	WRITING PAPER AND CERTAIN CLASSES OF PRINTED MATTER - TRIMMED SIZES - A AND B SERIES, AND INDICATION OF MACHINE DIRECTION
ISO 68-1 : 1998(R2014)	ISO GENERAL PURPOSE SCREW THREADS - BASIC PROFILE - PART 1: METRIC SCREW THREADS
CSA Z412 : 2000	OFFICE ERGONOMICS - AN APPLICATION STANDARD FOR WORKPLACE ERGONOMICS
ISO/IEC 9995-1 : 2009(R2015)	INFORMATION TECHNOLOGY - KEYBOARD LAYOUTS FOR TEXT AND OFFICE SYSTEMS - PART 1: GENERAL PRINCIPLES GOVERNING KEYBOARD LAYOUTS
AAMI EC53 : 2013	ECG TRUNK CABLES AND PATIENT LEADWIRES
ISO 9186-1 : 2014	GRAPHICAL SYMBOLS - TEST METHODS - PART 1: METHODS FOR TESTING COMPREHENSIBILITY
CFR 29(PT1910.1000 TO END) : 0	LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR
NASA STD 3000 VOL 2 : 1995	MAN-SYSTEMS INTEGRATION STANDARDS - VOLUME 2
IEC 60601-2-27 : 3.0	MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT
IEC 60601-2-38 : 1.0	MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS
ISO 9186-2 : 2008(R2018)	GRAPHICAL SYMBOLS - TEST METHODS - PART 2: METHOD FOR TESTING PERCEPTUAL QUALITY
IEC 80416-1 : 2.0	BASIC PRINCIPLES FOR GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 1: CREATION OF GRAPHICAL SYMBOLS FOR REGISTRATION
AAMI TIR 12 : 2010	DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
EN 1089-3 : 2011	TRANSPORTABLE GAS CYLINDERS - GAS CYLINDER IDENTIFICATION (EXCLUDING LPG) - PART 3: COLOUR CODING
ANSI/HIMA MD70.1 : 1983	MEDICAL LUER TAPER FITTINGS - PERFORMANCE STANDARD
CFR 21(PTS1-99) : 0	FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
CGA V 5 : 2008(R2013)	DIAMETER INDEX SAFETY SYSTEM (NON-INTERCHANGEABLE LOW PRESSURE CONNECTIONS FOR MEDICAL GAS APPLICATIONS)
MIL STD 1472 : G	HUMAN ENGINEERING
AAMI ST81 : 2004	STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES
AAMI HE74 : 2001	HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES
ISO 7000 : 2014	GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS
AAMI ISO 14971 : 2007	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
AAMI ISO 13485 : 2016	MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
NASA STD 3000 VOL 1 : 1995	MAN-SYSTEMS INTEGRATION STANDARDS - VOLUME 1
ISO 594-2 : 1998	CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - PART 2: LOCK FITTINGS
AAMI EC13 : 2002	CARDIAC MONITORS, HEART RATE METERS AND ALARMS
ANSI S12.10 : 2002	ACOUSTICS - MEASUREMENT OF AIRBORNE NOISE EMITTED BY INFORMATION TECHNOLOGY AND TELECOMMUNICATIONS EQUIPMENT
AAMI ID54 : 1996	ENTERAL FEEDING SET ADAPTERS AND CONNECTORS
ISO 594-1 : 1986	CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS
ISO 13407 : 1999	HUMAN-CENTRED DESIGN PROCESSES FOR INTERACTIVE SYSTEMS
DIN 13252 : 1984	INHALATIONAL ANAESTHETIC APPARATUS, REQUIREMENTS FOR SAFETY AND TESTING
ISO 9703-2 : 1994	ANAESTHESIA AND RESPIRATORY CARE ALARM SIGNALS - PART 2: AUDITORY ALARM SIGNALS
ISO TR 16982 : 2002(R2005)	ERGONOMICS OF HUMAN-SYSTEM INTERACTION - USABILITY METHODS SUPPORTING HUMAN-CENTRED DESIGN

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AAMI HE75 : 2009(R2013)

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