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AAMI 62366 1 2015

AAMI 62366 1 2015

$131.66

ANSI/AAMI/IEC 62366-1:2015 – Medical Devices Part 1: Application of Usability Engineering to Medical Devices

Published By Publication Date Number of Pages
AAMI 2015 52
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This document specifies a process for a manufacturer to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process permits the manufacturer to assess and mitigates risks associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical devices
2 Objectives and uses of AAMI standards and recommended practices
3 Title page
4 Copyright information
5 Contents
6 Glossary of equivalent standards
7 Committee representation
9 Background of ANSI/AAMI adoption of IEC 62366-1:2015
10 Foreword
12 Introduction
13 1 * Scope
2 Normative references
3 Terms and definitions
14 Figure 1 – Relationship of the types of use
18 4 Principles
4.1 General requirements
4.1.1 * Usability engineering process
4.1.2 * Risk control as it relates to user interface design
19 4.1.3 Information for safety as it relates to usability
4.2 * Usability engineering file
4.3 Tailoring of the usability engineering effort
5 * Usability engineering process
5.1 * Prepare use specification
20 5.2 * Identify user interface characteristics related to safety and potential use errors
5.3 * Identify known or foreseeable hazards and hazardous situations
5.4 * Identify and describe hazard-related use scenarios
21 5.5 * Select the hazard-related use scenarios for summative evaluation
5.6 * Establish user interface specification
5.7 * Establish user interface evaluation plan
5.7.1 General
22 5.7.2 * Formative evaluation planning
5.7.3 * Summative evaluation planning
23 5.8 * Perform user interface design, implementation and formative evaluation
5.9 * Perform summative evaluation of the usability of the user interface
24 5.10 User interface of unknown provenance
25 Annex A: General guidance and rationale
A.1 General guidance
A.2 Rationale for requirements in particular clauses and subclauses
29 Figure A.1 – Model of USER-MEDICAL DEVICE interaction
30 Figure A.2 – Relationship of TASKS and functions within a USE SCENARIO
31 Figure A.3 – Relationship of TASKS and functions and USE ERROR within a HAZARD-RELATED USE SCENARIO
36 Figure A.4 – The relationship between the RISK MANAGEMENT PROCESS (ISO 14971:2007)and the USABILITY ENGINEERING PROCESS (IEC 62366-1)
41 Annex B: Examples of possible hazardous situations related to usability
Table B.1 – Glossary of relevant RISK MANAGEMENT terms
Table B.2 – Examples of HARM due to RISK caused by USE ERROR(S) or poor USABILITY
44 Annex C: Evaluation of a user interface of unknown provenance (uoup)
C.1 General
C.2 Usability engineering process for user interface of unknown provenance
C.2.1 * Use specification
C.2.2 * Review of post-production information
45 C.2.3 Hazards and hazardous situations related to usability
C.2.4 Risk control
C.2.5 Residual risk evaluation
46 Annex D: Types of medical device use, with examples
47 Figure D.1 – Interrelationships between the different types of MEDICAL DEVICE use, with examples
48 Annex E: Reference to the essential principles
Table E.1 – Correspondence between this document and the essential principles
49 Bibliography
51 Index of defined terms

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AAMI 62366 1 2015
$131.66