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BS EN 60601-1-6 : 2010

Current

Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2010

FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 Replacement of requirements given in IEC 62366
Annex A (informative) - General guidance and rationale
Annex B (informative) - Mapping between the elements of
        IEC 60601-1-6:2006 and the related elements in
        IEC 62366:2007
Annex C (informative) - References to items of USABILITY
        provided in IEC 62366:2007 and their use in other
        standards
Bibliography
Index of defined terms used with this collateral standard
Annex ZA (normative) - Normative references to international
         publications with their European publications
Annex ZZ (informative) - Coverage of Essential Requirements of
         EU Directives

Describes a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.

Committee
CH/62/1
DevelopmentNote
Supersedes 03/304741 DC. (12/2004) 2010 Edition remains active & will be withdrawn on 31/12/2018. 2010 Edition Re-Issued in July 2015 & incorporates AMD 1 2015. Supersedes 12/30258857 DC. (07/2015)
DocumentType
Standard
Pages
34
PublisherName
British Standards Institution
Status
Current
Supersedes

ISO 9241-920:2009 Ergonomics of human-system interaction Part 920: Guidance on tactile and haptic interactions
ISO 9241-400:2007 Ergonomics of humansystem interaction Part 400: Principles and requirements for physical input devices
ISO 9241-11:1998 Ergonomic requirements for office work with visual display terminals (VDTs) Part 11: Guidance on usability
ISO 9241-307:2008 Ergonomics of human-system interaction — Part 307: Analysis and compliance test methods for electronic visual displays
EN ISO 9241-110:2006 Ergonomics of human-system interaction - Part 110: Dialogue principles (ISO 9241-110:2006)
ISO 9241-171:2008 Ergonomics of human-system interaction — Part 171: Guidance on software accessibility
EN ISO 9241-171:2008 Ergonomics of human-system interaction - Part 171: Guidance on software accessibility (ISO 9241-171:2008)
ISO 9241-110:2006 Ergonomics of human-system interaction Part 110: Dialogue principles
EN ISO 9241-11:1998 Ergonomic requirements for office work with visual display terminals (VDTs) - Part 11: Guidance on usability (ISO 9241-11:1998)
ISO 9241-304:2008 Ergonomics of human-system interaction — Part 304: User performance test methods for electronic visual displays
EN ISO 9241-20:2009 Ergonomics of human-system interaction - Part 20: Accessibility guidelines for information/communication technology (ICT) equipment and services (ISO 9241-20:2008)
EN ISO 13407:1999 Human-centred design processes for interactive systems (ISO 13407:1999)
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 9241-210:2010 Ergonomics of human-system interaction Part 210: Human-centred design for interactive systems
ISO 9241-305:2008 Ergonomics of human-system interaction — Part 305: Optical laboratory test methods for electronic visual displays
EN ISO 9241-400:2007 Ergonomics of human-system interaction - Part 400: Principles and requirements for physical input devices (ISO 9241-400:2007)
ISO 9241-20:2008 Ergonomics of human-system interaction Part 20: Accessibility guidelines for information/communication technology (ICT) equipment and services
ISO/IEC 14598-1:1999 Information technology Software product evaluation Part 1: General overview
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 14598-6:2001 Software engineering Product evaluation Part 6: Documentation of evaluation modules
EN ISO 9241-302:2008 Ergonomics of human-system interaction - Part 302: Terminology for electronic visual displays (ISO 9241-302:2008)
ISO/IEC 14598-4:1999 Software engineering Product evaluation Part 4: Process for acquirers
ISO/IEC 14598-2:2000 Software engineering Product evaluation Part 2: Planning and management
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO/IEC 15910:1999 Information technology Software user documentation process
ISO 9241-303:2011 Ergonomics of human-system interaction — Part 303: Requirements for electronic visual displays
ISO/IEC 18019:2004 Software and system engineering Guidelines for the design and preparation of user documentation for application software
ISO/IEC 25062:2006 Software engineering Software product Quality Requirements and Evaluation (SQuaRE) Common Industry Format (CIF) for usability test reports
EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
EN ISO 9241-300:2008 Ergonomics of human-system interaction - Part 300: Introduction to electronic visual display requirements (ISO 9241-300:2008)
EN ISO 9241-307:2008 Ergonomics of human-system interaction - Part 307: Analysis and compliance test methods for electronic visual displays (ISO 9241-307:2008)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO/IEC 14598-3:2000 Software engineering Product evaluation Part 3: Process for developers
ISO 9241-2:1992 Ergonomic requirements for office work with visual display terminals (VDTs) — Part 2: Guidance on task requirements
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 9241-300:2008 Ergonomics of human-system interaction — Part 300: Introduction to electronic visual display requirements
EN ISO 9241-305:2008 Ergonomics of human-system interaction - Part 305: Optical laboratory test methods for electronic visual displays (ISO 9241-305:2008)
ISO/IEC 14598-5:1998 Information technology Software product evaluation Part 5: Process for evaluators
ISO 13407:1999 Human-centred design processes for interactive systems
ISO 9241-410:2008 Ergonomics of human-system interaction Part 410: Design criteria for physical input devices
ISO 9241-302:2008 Ergonomics of human-system interaction — Part 302: Terminology for electronic visual displays
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)
ISO/TR 16982:2002 Ergonomics of human-system interaction Usability methods supporting human-centred design

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