I.S. EN 62366-1:2015/A1:2020
Current
The latest, up-to-date edition.
Medical devices - Part 1: Application of usability engineering to medical devices
Hardcopy , PDF
English
03-09-2020
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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
This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY.
| Committee |
TC 62
|
| DocumentType |
Standard
|
| Pages |
172
|
| ProductNote |
The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| IEC 62366-1:2015/AMD1:2020 | Identical |
| EN 62366-1:2015/A1:2020 | Identical |
| AAMI HE74 : 2001 | HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES |
| AAMI HE75 : 2009 | HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
| AAMI HE48 : 1993 | HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES |
| IEC 60601-1-8:2006 | 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 |
| ISO/IEC Guide 63:2019 | Guide to the development and inclusion of aspects of safety in International Standards for medical devices |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| IEC 60601-1-11:2015 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| IEC 60601-1:2005 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 16142-2:2017 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 9241-11:2018 | Ergonomics of human-system interaction — Part 11: Usability: Definitions and concepts |
| ISO/TR 24971:2020 | Medical devices — Guidance on the application of ISO 14971 |
| ISO 7010:2019 | Graphical symbols — Safety colours and safety signs — Registered safety signs |
| IEC TR 61258:2008 | Guidelines for the development and use of medical electrical equipment educational materials |
| IEC 60601-1-6:2010 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
Access your standards online with a subscription
-
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.
Important note : Users cannot be edited or removed once added to your Multi user PDF.