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IEC 62366

Medical devices – Application of usability engineering to medical devices

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Organization: IEC
Publication Date: 1 January 2014
Status: inactive
Page Count: 442
ICS Code (Medical equipment): 11.040

Document History

IEC 62366
January 1, 2014
Medical devices – Application of usability engineering to medical devices
A description is not available for this item.
IEC 62366
January 1, 2014
AMENDMENT 1 Medical devices – Application of usability engineering to medical devices
A description is not available for this item.
IEC 62366
October 1, 2007
Medical devices – Application of usability engineering to medical devices
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This USABILITY ENGINEERING...

References

This document references:
IEC 60601-1-8 - 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
Published by IEC on July 1, 2020
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
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:
IEC 60601-1-8 - 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
Published by IEC on July 1, 2020
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
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 9001 - Quality management systems — Requirements
Published by ISO on September 15, 2015
This International Standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet...
This document references:
ISO 9000 - Quality management systems — Fundamentals and vocabulary
Published by ISO on September 15, 2015
This International Standard describes the fundamental concepts and principles of quality management which are universally applicable to the following: — organizations seeking sustained success...
This document is referenced by:
AAMI HE75 - Human factors engineering - Design of medical devices
Published by AAMI on January 1, 2009
General This recommended practice addresses a broad range of human factors engineering (HFE) topics in a structured format. Examples are provided, as are references to more detailed information. The...
This document is referenced by:
JIS T 5602 - Dental - patient chair
Published by JSA on March 1, 2014
A description is not available for this item.
This document is referenced by:
JIS T 5701 - Dentistry - Dental units - Part 1: General requirements and test methods
Published by JSA on March 1, 2014
A description is not available for this item.
This document is referenced by:
JIS T 0601-2-16 - Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Published by JSA on March 1, 2014
A description is not available for this item.
This document is referenced by:
BS EN ISO 27427 - Anaesthetic and respiratory equipment - Nebulizing systems and components
Published by BSI on February 28, 2014
A description is not available for this item.
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