Translator Reviews ( English → Japanese )

English

Classification of Medical Devices
Medical devices may be classified into 4 risk classes.

Class
Risk Lv
Examples
A
Low Risk
Surgical retractors / tongue depressors
B
Low-moderate Risk
Hypodermic Needles / suction equipment
C
Moderate-high Risk
Lung ventilator / bone fixation plate
D
High Risk
Heart valves / implantable defibrillator

Classification of a medical device will depend upon a series of factors, including:
How long the device is intended to be in use
Whether the device is invasive
Whether the device is implantable
Whether the device is active
Whether the device contains a drug or biologic component
The classification rules are adopted from the guidance developed by the Global Harmonization Task Force.

Japanese

医療器具の分類
医療器具は次の4つのリスク・レヴェルに応じて分類される

分類
リスク・レベル
用具の例
A
低リスク
外科用開創器 / 舌圧子
B
低-中リスク
皮下針 / 吸引器
C
中-高リスク
肺換気装置 / 骨折固定用プレート
D
高リスク
人工心臓弁 / 植込み型除細動器