I.S. EN 60601-1-6:2010/A2:2021
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Hardcopy , PDF
English
02-08-2021
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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
This International Standard specifies 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 |
TC 62
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-8628-9
|
| Pages |
112
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN 60601-1-6:2010/A2:2021 | Identical |
| IEC 60601-1-6:2010/AMD2:2020 | Identical |
| ISO 9241-920:2009 | Ergonomics of human-system interaction — Part 920: Guidance on tactile and haptic interactions |
| ISO 9241-400:2007 | Ergonomics of human—system 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 |
| ISO 9241-171:2008 | Ergonomics of human-system interaction — Part 171: Guidance on software accessibility |
| ISO 14155:2020 | Clinical investigation of medical devices for human subjects — Good clinical practice |
| ISO 9241-110:2006 | Ergonomics of human-system interaction — Part 110: Dialogue principles |
| ISO 9241-304:2008 | Ergonomics of human-system interaction — Part 304: User performance test methods for electronic visual displays |
| ISO 9241-305:2008 | Ergonomics of human-system interaction — Part 305: Optical laboratory test methods for electronic visual displays |
| 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 |
| ISO/IEC 14598-6:2001 | Software engineering — Product evaluation — Part 6: Documentation of evaluation modules |
| 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 |
| ISO/IEC 15910:1999 | Information technology — Software user documentation process |
| ISO 9241-210:2019 | Ergonomics of human-system interaction — Part 210: Human-centred design for interactive systems |
| 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 |
| IEC TR 62366-2:2016 | Medical devices - Part 2: Guidance on the application of usability engineering to medical devices |
| ISO 9241-303:2008 | Ergonomics of human-system interaction — Part 303: Requirements for electronic visual displays |
| 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 9241-300:2008 | Ergonomics of human-system interaction — Part 300: Introduction to electronic visual display requirements |
| 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 |
| ISO/TR 16982:2002 | Ergonomics of human-system interaction — Usability methods supporting human-centred design |
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