ANSI/AAMI/IEC 62366-1:2015(R2021)+AMD1:2020
Current
The latest, up-to-date edition.
Medical devices—Part 1: Application of usability engineering to medical devices, including Amendment 1
English
01-07-2020
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 210
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-763-1
|
| Pages |
54
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| ISO 9241-11:1998 | Ergonomic requirements for office work with visual display terminals (VDTs) — Part 11: Guidance on usability |
| AAMI HE74 : 2001 | HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES |
| AAMI HE75 : 2009 | HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
| ISO 7010:2011 | Graphical symbols — Safety colours and safety signs — Registered safety signs |
| 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 60601-1:1988 | Medical electrical equipment - Part 1: General requirements for safety |
| 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/TR 24971:2020 | Medical devices — Guidance on the application of ISO 14971 |
| IEC 60601-1-6:2010 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.