AAMI IEC 62366-1 : 2015

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Available format(s): Hardcopy, PDF

Superseded date: 27-08-2020

Language(s): English

Published date: 01-01-2015

Publisher: Association for the Advancement of Medical Instrumentation

Table of Contents - (Show below) - (Hide below)

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of IEC 62366-1:2015
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

Abstract - (Show below) - (Hide below)

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

General Product Information - (Show below) - (Hide below)

Development Note	Supersedes AAMI IEC 62366. (11/2017) NEW CHILD AMD 1 2020 IS NOW ADDED
Document Type	Standard
ISBN
Pages
Product Note	NEW CHILD AMD 1 2020 IS NOW ADDED
Published
Publisher	Association for the Advancement of Medical Instrumentation
Status	Superseded
Superseded By	ANSI/AAMI/IEC 62366-1:2015(R2021)+AMD1:2020
Supersedes	AAMI IEC 62366 : 2015

Standards Referenced By This Book - (Show below) - (Hide below)

AAMI TIR59:2017	INTEGRATING HUMAN FACTORS INTO DESIGN CONTROLS
AAMI TIR57 : 2016	PRINCIPLES FOR MEDICAL DEVICE SECURITY - RISK MANAGEMENT
AAMI TIR71 : 2017	GUIDANCE FOR LOGGING OF ALARM SYSTEM DATA

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

ISO 9241-11:1998	Ergonomic requirements for office work with visual display terminals (VDTs) Part 11: Guidance on usability
ISO 7010:2011	Graphical symbols Safety colours and safety signs Registered safety signs
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
IEC 60601-1-6:2010+AMD1:2013 CSV	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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
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
ISO 9001:2015	Quality management systems — Requirements
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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