AAMI HIT1000-4PS:2020
Current
Current
The latest, up-to-date edition.
Safety and effectiveness of health IT software and systems—Part 4: Application of human factors engineering
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
07-07-2020
€17.50
Excluding VAT
This provisional standard describes how to apply human factors engineering to health IT (HIT) systems and software user interfaces throughout the HIT product lifecycle to ensure such systems are reasonably safe and effective.
| DocumentType |
Standard
|
| ISBN |
978-1-57020-759-4
|
| Pages |
75
|
| ProductNote |
THIS STANDARD ALSO REFERS TO :AAMI/IEC 62366-1,AAMI HIT1000-2 (PS) ,/AAMI/ISO 14971
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| IEC 62366-1:2015 | Medical devices - Part 1: Application of usability engineering to medical devices |
| IEC TR 62366-2:2016 | Medical devices - Part 2: Guidance on the application of usability engineering to medical devices |
| ISO 9001:2015 | Quality management systems — Requirements |
| ANSI/AAMI HE75:2009(R2018) | Human factors engineering—Design of medical devices |
| ISO 9241-11:2018 | Ergonomics of human-system interaction — Part 11: Usability: Definitions and concepts |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 31000:2018 | Risk management — Guidelines |
Summarise
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.