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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
Hardcopy , PDF
14-09-2020
English
13-01-2016
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
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