British Standards Institution

Source:: IEC
Committee:: CH/210 - Quality management and corresponding general aspects for medical devices
Categories:: Information management | Standardization. General rules

Scope

This Part of IEC 62366, which is a Technical Specification, contains background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS both as defined in IEC 62366-1:2015 and as supporting goals other than SAFETY. This Technical Specification is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information.

Purpose

The purpose of this project is to update the informative material in IEC TR 62366-2:2016 to harmonize with latest amendment to the normative standard IEC 62366-1:2015+A1:2020 and change from a Technical Report to a Technical Specification.

IEC 62366-1:2015+A1:2020 is the premier international standard for usability engineering for medical devices and this informative Technical Specification will help standards users to comply with the normative standard.

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal

Proposal start date:

19/01/2024

Proposal end date:

14/03/2024

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

IEC/PWI TS 62366-2 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices

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