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BS EN 62366 : 2008

BS EN 62366 : 2008

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Amended by

BS EN 62366:2008+A1:2015

Available format(s)

Hardcopy , PDF

Superseded date

06-30-2015

Language(s)

English

Published date

01-01-2015

Publisher

British Standards Institution

INTRODUCTION
1 Scope
2 Normative references
3 Terms and definition
4 Principals
5 USABILITY ENGINEERING PROCESS
6 ACCOMPANYING DOCUMENT
7 Training and materials for training
Annex A (informative) - General guidance and rationale
Annex B (informative) - Categories of USER action
Annex C (informative) - Examples of USE ERRORS,
        ABNORMAL USE and possible causes
Annex D (informative) - Guidance on the USABILITY
        ENGINEERING PROCESS
Annex E (informative) - Questions that can be
        used to identify MEDICAL DEVICE characteristics
        associated with USABILITY that could impact on SAFETY
Annex F (informative) - Examples of possible USABILITY
        related HAZARDOUS SITUATIONS
Annex G (informative) - USABILITY goals: Illustrative
        example for a home parenteral infusion pump
Annex H (informative) - Sample USABILITY SPECIFICATION
        and its inputs
Annex I (informative) - Recommended reading list
Annex J (informative) - Reference to the essential principles
Annex K (normative) - Evaluation of a USER INTERFACE OF
        UNKNOWN PROVENANCE (UOUP)
Annex ZA (normative) - Normative references to international
         publications with their corresponding European
         publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EC Directives
Bibliography
Index of defined terms

Describes a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE.

Committee
CH/62/1
DevelopmentNote
Supersedes 06/30112971 DC. (05/2008) 2008 Edition remains active & will be withdrawn on 14/04/2018. 2008 Edition Re-issued in June 2015 & incorporates AMD 1 2015. Supersedes 12/30269445 DC. (02/2015) Superseded by BS EN 62366-1 and BS PD IEC TR 62366-2 but remains current and will be withdrawn on 31/03/2018. (05/2016)
DocumentType
Standard
Pages
108
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN 62366 : 2008 AMD 1 2015 Identical
IEC 62366:2007+AMD1:2014 CSV Identical

BS PAS 277(2015) : 2015 HEALTH AND WELLNESS APPS - QUALITY CRITERIA ACROSS THE LIFE CYCLE - CODE OF PRACTICE

ISO 9241-11:1998 Ergonomic requirements for office work with visual display terminals (VDTs) Part 11: Guidance on usability
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
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

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PDF - English
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