送報的 發問時間: 社會與文化語言 · 1 0 年前

請問FDA 510(K) Class 1 exempt的意思

The system is marked as a CE-IVD product in the European Union, and as a 510(K) Class 1 exempt IVD product in the US.

請問關於510(K)的這半句應該怎麼翻成中文?

已更新項目:

抱歉沒說清楚,我的問題是exempt在這邊要怎麼翻,那整句話的中文應該怎麼寫,510(K)我已經大概知道是什麼了,謝謝!

1 個解答

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  • 1 0 年前
    最佳解答

    有可能是無塵等級

    譬如 10K, 100K, 1000K 是無塵等級的稱呼法

    2006-08-04 17:41:53 補充:

    IVD, 體外診斷(In vitro diagnostics)

    2006-08-04 17:48:29 補充:

    510(K) 是美國 FDA 的條款. 所以就是說這個東西在美國 510K 條款裡是免責的, 也就是可以在美國販售的意思.

    2006-08-04 17:51:53 補充:

    Q: What is "510(K)"?http://apersonalsolution.com/fdaq&a.htm#6

    2006-08-04 17:52:22 補充:

    A: 510(K) is an actual section of the Federal Food, Drug and Cosmetic Act that requires Medical Device manufacturers to notify the FDA of their intent to market a Medical Devise.

    2006-08-04 17:52:46 補充:

    Under 510(K), before a manufacturer can market a Medical Device in the United States, they must demonstrate to the FDA that the device is "Substantially Equivalent" (at least as safe and effective) to a device already on the market.

    參考資料: myself
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