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Superseded

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BS EN 62366-1 - MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES

Available format(s)

Hardcopy , PDF

Superseded date

06-30-2015

Language(s)

English

Publisher

British Standards Institution

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Principles
5 USABILITY ENGINEERING PROCESS
Annex A (informative) - General guidance and
        rationale
ANNEX B (informative) - Examples of possible
        HAZARDOUS SITUATIONS related to
        USABILITY
Annex C (normative) - Evaluation of a USER
        INTERFACE OF UNKNOWN
        PROVENANCE (UOUP)
Annex D (informative) - Types of MEDICAL
        DEVICE use with examples
Annex E (informative) - Reference to the
        essential principles
Bibliography
Index of defined terms

BS EN 62366-1.

Committee	CH/62/1
DocumentType	Draft
Pages	50
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN 62366-1:2015

ISO 9241-11:1998	Ergonomic requirements for office work with visual display terminals (VDTs) Part 11: Guidance on usability
ISO 7010:2011	Graphical symbols Safety colours and safety signs Registered safety signs
AAMI HE48 : 1993	HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
IEC 60601-1-8:2006+AMD1:2012 CSV	Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
ISO/IEC Guide 51:2014	Safety aspects Guidelines for their inclusion in standards
ISO/TR 16142:2006	Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO 9001:2015	Quality management systems — Requirements
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO 14971:2007	Medical devices Application of risk management to medical devices