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BSI - BS PD IEC/TR 62366-2

Medical devices Part 2: Guidance on the application of usability engineering to medical devices

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Organization: BSI
Publication Date: 31 May 2016
Status: active
Page Count: 108
ICS Code (Medical equipment in general): 11.040.01

Document History

BS PD IEC/TR 62366-2
May 31, 2016
Medical devices Part 2: Guidance on the application of usability engineering to medical devices
A description is not available for this item.

References

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:
ISO TS 19218-1 - Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes AMENDMENT 1
Published by ISO on January 15, 2013
A description is not available for this item.
This document references:
AAMI TIR49 - Design of training and instructional materials for medical devices used in non-clinical environments
Published by AAMI on January 1, 2013
The purpose of this technical information report (TIR) is to provide a relevant source of information, design criteria, and guidelines for the instructional and training materials and processes...
This document references:
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 references:
AAMI TIR49 - Design of training and instructional materials for medical devices used in non-clinical environments
Published by AAMI on January 1, 2013
The purpose of this technical information report (TIR) is to provide a relevant source of information, design criteria, and guidelines for the instructional and training materials and processes...
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:
ISO TS 19218-1 - Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes AMENDMENT 1
Published by ISO on January 15, 2013
A description is not available for this item.
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...
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