I.S. EN 62366-1:2015/AC:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
Hardcopy , PDF
English
13-01-2016
14-09-2020
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 * ENGINEERING PROCESS OF SUITABILITY FOR USE
Annex A (informative) General guidelines and justifications
ANNEX B (informative) Examples of possible HAZARDOUS SITUATIONS relating to
Annex C (normative) Assessment of an UNKNOWN USER INTERFACE
Annex D (informative) Types of use of MEDICAL DEVICE with examples
Annex E (informative) Reference to 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
|
| ISBN |
978-2-8322-2281-2
|
| Pages |
126
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| IEC 62366-1:2015 | Identical |
| EN 62366-1:2015 | Identical |
A newer version of this standard is available.
View Current Edition
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : Users cannot be edited or removed once added to your Multi user PDF.