IEC 62366:2007+AMD1:2014 CSV

FOREWORD
INTRODUCTION
INTRODUCTION TO THE AMENDMENT
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

IEC 62366:2007+A1:2014 Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a medical device. This consolidated version consists of the first edition (2007) and its amendment 1 (2014). Therefore, no need to order amendment in addition to this publication.