I.S. EN 62366-1:2015&AC: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.
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
Important note : All end users must be registered with an Account prior to user licenses being assigned.Access your standards online with a subscription
Features
-
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.