AAMI HE75 : 2009(R2013)
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
Published date
10-08-2018
Superseded date
27-03-2020
Superseded by
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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
Specifies a broad range of human factors engineering (HFE) topics in a structured format.
| Committee |
HE
|
| DevelopmentNote |
Supersedes AAMI HE48. (02/2010) Also available in CD-ROM format. (04/2016) Also available in a set of Book and CD. (04/2017)
|
| DocumentType |
Revision
|
| ProductNote |
Reconfirmed 2013 PDF has been updated Price has been updated
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| ISO 9241-11:1998 | Ergonomic requirements for office work with visual display terminals (VDTs) — Part 11: Guidance on usability |
| ISO 9186:2001 | Graphical symbols — Test methods for judged comprehensibility and for comprehension |
| IEC 60245-1:2003+AMD1:2007 CSV | Rubber insulated cables - Rated voltages up to and including 450/750 V - Part 1: General requirements |
| 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 | ISO general purpose screw threads — Basic profile — Part 2: Inch screw threads |
| 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 |
| MIL-HDBK-759 Revision C:1995 | Human Engineering Design Guidelines (No S/S Document) |
| IEEE 802.15.4-2011 | IEEE Standard for Local and metropolitan area networks--Part 15.4: Low-Rate Wireless Personal Area Networks (LR-WPANs) |
| ANSI/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 | Ergonomics — Ergonomics of human-system interaction — Human-centred lifecycle process descriptions |
| IEC 60601-1-10:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers |
| 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 | IEEE Standard for Information technology--Telecommunications and information exchange between systems Local and metropolitan area networks--Specific requirements - Part 11: Wireless LAN Medium Access Control (MAC) and Physical Layer (PHY) Specifications |
| 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 60601-1-8:2006+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 |
| ANSI S3.34:1986 | 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 62366:2007+AMD1:2014 CSV | 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 | Gas cylinders for medical use — Marking for identification of content |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ISO 216:2007 | Writing paper and certain classes of printed matter — Trimmed sizes — A and B series, and indication of machine direction |
| ISO 68-1:1998 | ISO general purpose screw threads — Basic profile — Part 1: Metric screw threads |
| ISO/IEC 9995-1:2009 | 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: Method 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 60601-2-27:2011 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| IEC 60601-2-38:1996 | Medical electrical equipment - Part 2: Particular requirementsfor the safety of electrically operated hospital beds |
| ISO 9186-2:2008 | Graphical symbols — Test methods — Part 2: Method for testing perceptual quality |
| IEC 80416-1:2008 | 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 Revision G:2012 | Human Engineering |
| ISO 7000:2014 | Graphical symbols for use on equipment — Registered symbols |
| 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 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 |
| 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 13252:1984-06 | 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 | Ergonomics of human-system interaction — Usability methods supporting human-centred design |
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