IEC/TR 62366-2:2016

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

Publication date: Apr 28, 2016

General information

Current stage: 90.92 Effective date: Jan 15, 2024

Originator: IEC

Owner: ISO/TC 210

Type: Technical Report

ICS: 11.040.01

Languages: English

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Status: Published

PDF - ALL 42,401

Paper - ALL 42,401

CD - ALL 42,401

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Scope

IEC TR 62366-2:2016(E), which is a Technical Report, 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 report is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information.

Life cycle

NOW

PUBLISHED
IEC/TR 62366-2:2016
90.92 Standard to be revised
Jan 15, 2024

REVISED BY

IN_DEVELOPMENT
IEC/CD TS 62366-2