UNLIMITED FREE
ACCESS TO THE WORLD'S BEST IDEAS

SUBMIT
Already a GlobalSpec user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your GlobalSpec Experience

Select Your Free Newsletters

Industry Newsletters

Select Your Free Product Alerts

Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

CSA - IEC 62366-1-15 AMD 1

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

inactive
Organization: CSA
Publication Date: 1 January 2021
Status: inactive
Page Count: 44
ICS Code (Medical equipment in general): 11.040.01
scope:

NOTE 1 SAFETY is freedom from unacceptable RISK. Unacceptable RISK can arise from USE ERROR, which can lead to exposure to HAZARDS including loss or degradation of clinical performance.

Document History

IEC 62366-1-15 AMD 1
January 1, 2021
Medical devices — Part 1: Application of usability engineering to medical devices
NOTE 1 SAFETY is freedom from unacceptable RISK. Unacceptable RISK can arise from USE ERROR, which can lead to exposure to HAZARDS including loss or degradation of clinical performance.
CSA IEC 62366-1
January 1, 2015
Medical devices — Part 1: Application of usability engineering to medical devices
This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN...
IEC 62366-1:15
January 1, 2015
Medical devices — Part 1: Application of usability engineering to medical devices
This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN...
CAN/CSA-IEC 62366-1:15
January 1, 2015
Medical devices - Part 1: Application of usability engineering to medical devices
This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN...

References

This document references:
ISO 14971 - Medical devices - Application of risk management to medical devices
Published by ISO 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:
ISO 16142-1 - Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non‐IVD medical devices and guidance on the selection of standards
Published by ISO on March 1, 2016
This part of ISO 16142, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical...
This document references:
ISO 16142-2 - Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
Published by ISO on August 1, 2017
This document, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to...
This document references:
IEC 60601-1 - MEDICAL ELECTRICAL EQUIPMENT – Part 1: General requirements for basic safety and essential performance
Published by IEC on March 1, 2021
A description is not available for this item.
This document references:
IEC 60601-1-11 - Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
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 for use in the HOME HEALTHCARE ENVIRONMENT, as defined...
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:
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:
ISO TR 24971 - Medical devices - Guidance on the application of ISO 14971
Published by ISO on June 1, 2020
This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019. The risk management process can be part...
This document references:
ISO/IEC GUIDE 63 - Guide to the development and inclusion of aspects of safety in International Standards for medical devices
Published by ISO on August 1, 2019
This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well-established risk...
This document is referenced by:
C22.2 NO. 80601-2-55:21 - Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
Published by CSA on January 1, 2021
This Standard applies to ME EQUIPMENT and ME SYSTEMS that are intended to be installed or used in accordance with CSA C22.1, Canadian Electrical Code, Part I.
View Less
View All
Advertisement