依據EN ISO 14971：2012版，本產品之風險管理過程需涵蓋產

依據EN ISO 14971：2012版，本產品之風險管理過程需涵蓋產品之全部生命週期，隨時鑑別與產品有關危害和評估相關的風險，並控制這些風險執行有效性的風險管理。本風險管理報告根據風險管理計畫，制定出本產品上市後監督之階段性風險管理之階段性審查。

結果 (英文) 1:

In accordance with EN ISO 14971: 2012 edition, the risk management process needs to cover all of the product life cycle of a product, the product at any time to identify the risks associated with the hazards and assess the effectiveness of the implementation and control these risks risk management. This risk management reports based on the risk management plan, worked out after this stage of the examination and supervision of market risk management stage.

結果 (英文) 2:

In accordance with EN ISO 14971:2012, the risk management process for this product covers the entire life cycle of the product, is always available to identify risks associated with product-related hazards and assessments, and to control risk management of the effectiveness of these risk senforcement. This risk management report, based on the risk management plan, develops a phased review of the phased risk management of this product after listing.

結果 (英文) 3:

According to EN ISO 14971:2012, the risk management process of the product shall cover the whole life cycle of the product, identify hazards related to the product and assess risks at any time, and control these risks to implement effective risk management. This risk management report, in accordance with the risk management plan, formulates the periodic review of the periodic risk management for post market supervision of this product.