AAMI HE48 : 1993
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Available format(s)
Hardcopy , PDF
Superseded date
21-01-2010
Language(s)
English
Published date
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Superseded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 |
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Hardcopy - English
PDF - English - DRM
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