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BS EN 62366-1:2015

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical devices Application of usability engineering to medical devices
Available format(s)

Hardcopy , PDF

Superseded date

09-01-2020

Language(s)

English

Published date

01-31-2016

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
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications

Describes a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY.

Committee
CH/62/1
DevelopmentNote
Supersedes 14/30244508 DC. (06/2015) Together with BS PD IEC TR 62366-2, it supersedes BS EN 62366 which remains current and will be withdrawn on 31/03/2018. (05/2016)
DocumentType
Standard
Pages
56
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN 62366-1:2015 Identical
EN 62366-1:2015/AC:2015 Identical

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
EN ISO 9241-11:1998 Ergonomic requirements for office work with visual display terminals (VDTs) - Part 11: Guidance on usability (ISO 9241-11:1998)
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
EN 60601-1-6:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
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
ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
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
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
ISO 9001:2015 Quality management systems — Requirements
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 14971:2007 Medical devices Application of risk management to medical devices
IEC TR 61258:2008 Guidelines for the development and use of medical electrical equipment educational materials
EN ISO 7010 : 2012 AMD 7 2017 GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS (ISO 7010:2011/AMD 7:2016)
EN 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
EN 60601-1-8:2007/A11:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012)

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