AAMI IEC 62366 : 2015

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of IEC 62366:2007
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Principles
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)
Bibliography
Index of defined terms

Specifies a usability engineering process, and provides guidance on how to implement and execute the process to provide safety in medical devices.