BS EN 62366-1 : 2015

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MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES

Publisher: British Standards Institution

Published: 01-01-2015

Available Formats: PDF - English, Hardcopy - English
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Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

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

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Published
Document Type	Standard
Status	Superseded
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/62/1
Supersedes	BS EN 62366 : 2008 14/30244508 DC : 0
Superseded By	BS EN 62366-1:2015+A1:2020

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
EN 62366-1 : 2015 COR 2015	Identical
IEC 62366-1 : 2015 COR 1 2016	Identical
EN 62366-1:2015	Identical
IEC 62366-1 : 2015 COR 1 2016	Identical
EN 62366-1:2015	Identical
EN 62366-1 : 2015 COR 2015	Identical

Standards Referencing This Book - (Show below) - (Hide below)

ISO 9241-11 : 1998	ERGONOMICS OF HUMAN-SYSTEM INTERACTION - PART 11: USABILITY: DEFINITIONS AND CONCEPTS
AAMI HE75 : 2009	HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
ISO 7010 : 2011	GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS
IEC 60601-1-11 : 2.0EN+(REDLINE+VERSION)	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
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) - PARTIE 11: GUIDANCE ON USABILITY
IEC 60601-1:2005+AMD1:2012 CSV	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
IEC 60601-1-6 :2013 (CON ED) 3.1	MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
ISO 13485 : 2016(R2020)	MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
EN 60601-1-6 : 2010 AMD 1 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 : 2.1	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
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)
EN 60601-1:2006/A1	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005)
ISO 9000 : 2015	QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY
AAMI HE74 : 2001	HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES
ISO 14971 : 2007(R2010)	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
IEC TR 61258 : 2.0	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 (IEC 60601-1-11:2015)
EN ISO 9000 : 2015	QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015)
EN 60601-1-8 : 2007 AMD 11 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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BS EN 62366-1 : 2015

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Abstract - (Show below) - (Hide below)

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