This document specifies a process for a manufacturer to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering or usability engineering) process assesses and mitigates risks associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.
Số hiệu tiêu chuẩn
ANSI/AAMI/IEC 62366-1
Tên tiêu chuẩn
Medical devices - Application of usability Engineering to medical devices
Ngày phát hành
2015-00-00
Tiêu chuẩn tương đương
IEC 62366-1 (2015-02), IDT
Từ khóa
Accompanying forms * Applications * Definitions * Design * Electrical engineering * Enterprises * Ergonomics * Field of applications * Fitness for purpose * Handlings * Medical devices * Medical equipment * Medical sciences * Medical technology * Production * Safety * Specification (approval) * Training * Usage * Validation * Medical products * Presentations * Implementation * Use
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