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BSI - BS EN 62366-1

Medical devices Part 1: Application of usability engineering to medical devices

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Organization: BSI
Publication Date: 30 June 2015
Status: inactive
Page Count: 56
ICS Code (Medical equipment in general): 11.040.01

Document History

BS EN 62366-1
June 30, 2015
Medical devices Part 1: Application of usability engineering to medical devices
A description is not available for this item.
BS EN 62366-1
June 30, 2015
Medical devices Part 1: Application of usability engineering to medical devices
A description is not available for this item.
BS EN 62366-1
June 30, 2015
Medical devices Part 1: Application of usability engineering to medical devices
A description is not available for this item.

References

This document references:
EN 1041 - Information supplied by the manufacturer of medical devices
Published by CEN on August 1, 2008
This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical...
This document references:
IEC 60601-1-6 - Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
Published by IEC on July 1, 2020
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL...
This document references:
EN ISO 14971 - Medical devices - Application of risk management to medical devices
Published by CEN on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
This document references:
IEC/TR 61258 - Guidelines for the development and use of medical electrical equipment educational materials
Published by IEC on August 1, 2008
IEC/TR 61258, which is a technical report, outlines a generic process for developing materials for education and training of OPERATORS of medical electrical equipment or a medical electrical system,...
This document references:
ISO 9241-11 - Ergonomics of human-system interaction - Part 11: Usability: Definitions and concepts
Published by ISO on March 1, 2018
This document provides a framework for understanding the concept of usability and applying it to situations where people use interactive systems, and other types of systems (including built...
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