Customer Support: +1 416-401-8730

Login to i2i Subscription Intertek.com
  • There are no items in your cart
Please enter a keyword to search
Advanced search

I.S. EN 60601-1-6:2010

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
Available format(s)

Hardcopy , PDF

Superseded date

04-09-2020

Language(s)

English

Published date

01-01-2010

Publisher

National Standards Authority of Ireland

Preview

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.

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.

DevelopmentNote
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
DocumentType
Standard
Pages
29
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

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
ISO 9241-171:2008 Ergonomics of human-system interaction — Part 171: Guidance on software accessibility
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
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
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
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 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
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

View more information
US$64.68
Excluding Tax where applicable
USD
CAD
CHF
CNY
DKK
EUR
GBP
HKD
IDR
INR
JPY
KRW
MXN
NOK
NZD
SEK
SGD
USD
ZAR
Hardcopy - English
PDF - English
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

or

Get in touch with us