AAMI IEC 62366 : 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
Hardcopy , PDF
01-11-2017
English
01-01-2015
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of IEC 62366:2007
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Principles
5 USABILITY ENGINEERING PROCESS
6 ACCOMPANYING DOCUMENT
7 Training and materials for training
Annex A (informative) - General guidance and rationale
Annex B (informative) - Categories of USER action
Annex C (informative) - Examples of USE ERRORS, ABNORMAL USE
and possible causes
Annex D (informative) - Guidance on the USABILITY ENGINEERING
PROCESS
ANNEX E (informative) - Questions that can be used to identify
MEDICAL DEVICE characteristics
associated with USABILITY that could
impact on SAFETY
ANNEX F (informative) - Examples of possible USABILITY
related HAZARDOUS SITUATIONS
Annex G (informative) - USABILITY goals: Illustrative example
for a home parenteral infusion pump
ANNEX H (informative) - Sample USABILITY SPECIFICATION and
its inputs
Annex I (informative) - Recommended reading list
Annex J (informative) - Reference to the essential principles
Annex K (normative) - Evaluation of a USER INTERFACE OF
UNKNOWN PROVENANCE (UOUP)
Bibliography
Index of defined terms
Specifies a usability engineering process, and provides guidance on how to implement and execute the process to provide safety in medical devices.
| Committee |
HE
|
| DevelopmentNote |
Supersedes AAMI HE74. (11/2010)
|
| DocumentType |
Standard
|
| Pages |
52
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| IEC 62366:2007+AMD1:2014 CSV | Identical |
| AAMI TIR61 : 2014 | GENERATING REPORTS FOR HUMAN FACTORS DESIGN VALIDATION RESULTS FOR EXTERNAL CARDIAC DEFIBRILLATORS |
| ANSI/AAMI EQ89:2015 | GUIDANCE FOR THE USE OF MEDICAL EQUIPMENT MAINTENANCE STRATEGIES AND PROCEDURES |
| AAMI TIR50 : 2014 | POST-MARKET SURVEILLANCE OF USE ERROR MANAGEMENT |
| AAMI TIR49 : 2013 | DESIGN OF TRAINING AND INSTRUCTIONAL MATERIALS FOR MEDICAL DEVICES USED IN NON-CLINICAL ENVIRONMENTS |
| ISO 9241-11:1998 | Ergonomic requirements for office work with visual display terminals (VDTs) Part 11: Guidance on usability |
| AAMI HE48 : 1993 | HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| 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 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| IEC TR 61258:2008 | Guidelines for the development and use of medical electrical equipment educational materials |
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