EN 62366 : 2008 AMD 1 2015

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definition
4 Principals
5 USABILITY ENGINEERING PROCESS
6 ACCOMPANYING DOCUMENT
7 Training and materials for training
Annex A (informative) - General guidance and rationale
Annex B (informative) - Categories of USER action
Annex C (informative) - Examples of USE ERRORS,
        ABNORMAL USE and possible causes
Annex D (informative) - Guidance on the USABILITY
        ENGINEERING PROCESS
Annex E (informative) - Questions that can be
        used to identify MEDICAL DEVICE characteristics
        associated with USABILITY that could impact on SAFETY
Annex F (informative) - Examples of possible USABILITY
        related HAZARDOUS SITUATIONS
Annex G (informative) - USABILITY goals: Illustrative
        example for a home parenteral infusion pump
Annex H (informative) - Sample USABILITY SPECIFICATION
        and its inputs
Annex I (informative) - Recommended reading list
Annex J (informative) - Reference to the essential principles
Annex K (normative) - Evaluation of a USER INTERFACE OF
        UNKNOWN PROVENANCE (UOUP)
Annex ZA (normative) - Normative references to international
         publications with their corresponding European
         publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EC Directives
Bibliography
Index of defined terms

Describes a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE.