AAMI HE48 : 1993
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
01-21-2010
English
01-01-1993
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
Describes the controls, displays, consoles, size, weight, and general user interface design of medical devices.
Committee |
HE
|
DocumentType |
Standard
|
Pages |
131
|
PublisherName |
Association for the Advancement of Medical Instrumentation
|
Status |
Superseded
|
SupersededBy |
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 |
CSA Z8185 : 2008 | 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 |
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 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
AAMI HE74 : 2001 | HUMAN FACTORS DESIGN PROCESS FOR 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 |
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 |
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) |
EN 60601-1-8:2007/A11:2017 | 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 | 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 |
I.S. EN ISO 8185:2009 | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
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 |
04/30088533 DC : DRAFT MARCH 2004 | BS EN ISO 8185 - RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
BS EN 62366 : 2008 | MEDICAL DEVICES - 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 |
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 |
ASTM F 1456 : 2001 | Standard Specification for Minimum Performance and Safety Requirements for Capnometers |
IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
EN 62366-1:2015/AC:2015 | MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015) |
EN ISO 8185:2009 | Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007) |
UNI EN ISO 8185 : 2009 | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
CAN/CSA-C22.2 NO. 60601-1-8:08 (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 (Adopted IEC 60601-1-8:2006, second edition, 2006-10) | Appareils électromédicaux - Partie 1-8: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences générales, essais et guide pour les systèmes d\'alarme des appareils et des systèmes électromédicaux (norme IEC 60601-1-8:2006 adoptée, deuxième édition, 2006-10) |
14/30244508 DC : 0 | BS EN 62366-1 - MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
BS EN ISO 8185:2007 | Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems |
BS EN 62366-1:2015 | Medical devices Application of usability engineering to medical devices |
ANSI/AAMI/IEC 60601-1-8:2006/A2:2021 | 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 | Standard Specification for Minimum Performance and Safety Requirements for Anesthetic Gas Monitors |
I.S. EN 62366:2009 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
DIN EN ISO 8185:2009-07 | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
ISO 3744:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane |
AAMI BP23 : 1986 | BLOOD PRESSURE TRANSDUCERS - INTERCHANGEABILITY AND PERFORMANCE OF RESISTIVE BRIDGE TYPE |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
AAMI DF2 : 3ED 96 | CARDIAC DEFIBRILLATOR DEVICES |
MIL-HDBK-759 Revision C:1995 | HANDBOOK FOR HUMAN ENGINEERING DESIGN GUIDELINES |
ANSI Z1979.8 : 1979 | ANESTHESIA MACHINES FOR HUMAN USE, MINIMUM PERFORMANCE AND SAFETY REQUIREMENTS FOR COMPONENTS & SYSTEMS OF CONTINUOUS FLOW, |
AAMI MIR2 : 1992 | GUIDELINE FOR ESTABLISHING AND ADMINISTERING MEDICAL INSTRUMENTATION MAINTENANCE PROGRAMS |
ICC A117.1 : 2009 | ACCESSIBLE AND USABLE BUILDINGS AND FACILITIES |
ISO 68:1973 | ISO general purpose screw threads Basic profile |
DIN 30600:1985-11 | GRAPHICAL SYMBOLS - REGISTRATION, DESIGNATION |
MIL-STD-1908 Base Document:1992 | DEFINITION OF HUMAN FACTOR TERMS (METRIC) |
ANSI HFS100 : 1988 | HUMAN FACTORS ENGINEERING OF VISUAL DISPLAY TERMINAL WORKSTATIONS - AMERICAN NATIONAL STANDARD FOR |
IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
DOD-HDBK-743 Revision A:1991 | ANTHROPOMETRY OF U.S. MILITARY PERSONNEL (METRIC) |
IEC 60417H:1987 | Eighth supplement. |
CGA V 5 : 2008(R2013) | DIAMETER INDEX SAFETY SYSTEM (NON-INTERCHANGEABLE LOW PRESSURE CONNECTIONS FOR MEDICAL GAS APPLICATIONS) |
MIL-STD-1472 Revision G:2012 | HUMAN ENGINEERING |
ISO 725:2009 | ISO inch screw threads Basic dimensions |
AAMI ECGC : 1983 | ECG CONNECTORS |
ANSI Z79.6 : 1975 | BREATHING TUBES, |
DIN 66009:1977-09 | FONT B FOR OPTICAL CHARACTER RECOGNITION - CHARACTERS, NOMINAL DIMENSIONS, AND FORMAT |
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.