ANSI/AAMI/IEC 62366-1:2015(R2021)+AMD1:2020
Current
Current
The latest, up-to-date edition.
Medical devices—Part 1: Application of usability engineering to medical devices, including Amendment 1
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
01-07-2020
€939.17
Excluding VAT
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 7010:2011 | Graphical symbols — Safety colours and safety signs — Registered safety signs |
| 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 |
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.