AAMI IEC 62366-1 : 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
Hardcopy , PDF
08-27-2020
English
01-01-2015
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Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of IEC 62366-1:2015
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles
5 USABILITY ENGINEERING PROCESS
Annex A (informative) - General guidance and rationale
Annex B (informative) - Examples of possible HAZARDOUS
SITUATIONS related to USABILITY
Annex C (normative) - Evaluation of a USER INTERFACE OF
UNKNOWN PROVENANCE (UOUP)
Annex D (informative) - Types of MEDICAL DEVICE use,
with examples
Annex E (informative) - Reference to the essential principles
Bibliography
Index of defined terms
Defines a PROCESS for a MANUFACTURER to analyze, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY.
| DevelopmentNote |
Supersedes AAMI IEC 62366. (11/2017) NEW CHILD AMD 1 2020 IS NOW ADDED
|
| DocumentType |
Standard
|
| Pages |
80
|
| ProductNote |
NEW CHILD AMD 1 2020 IS NOW ADDED
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| AAMI TIR59:2017 | INTEGRATING HUMAN FACTORS INTO DESIGN CONTROLS |
| AAMI TIR57 : 2016 | PRINCIPLES FOR MEDICAL DEVICE SECURITY - RISK MANAGEMENT |
| AAMI TIR71 : 2017 | GUIDANCE FOR LOGGING OF ALARM SYSTEM DATA |
| ISO 9241-11:1998 | Ergonomic requirements for office work with visual display terminals (VDTs) Part 11: Guidance on usability |
| ISO 7010:2011 | Graphical symbols Safety colours and safety signs Registered safety signs |
| 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 |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| 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 |
| ISO/IEC Guide 63:2012 | Guide to the development and inclusion of safety aspects in International Standards for medical devices |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| 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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