產(chǎn)品詳情
美國(guó)對(duì)口罩的準(zhǔn)入要求有哪些？
What are the admission requirements for masks in the United States?
答：美國(guó)對(duì)醫(yī)用口罩和防護(hù)口罩區(qū)分管理，其中醫(yī)用口罩由美國(guó)食品藥品監(jiān)督管理局（FDA）管理，而個(gè)人防護(hù)口罩則由美國(guó)國(guó)家職業(yè)安全衛(wèi)生研究所（NIOSH）管理。醫(yī)用口罩需通過(guò)FDA注冊(cè)，企業(yè)直接向FDA官網(wǎng)申請(qǐng)并提交相關(guān)材料。此外還有兩種可選途徑：一是已經(jīng)獲得NIOSH注冊(cè)的N95口罩，在產(chǎn)品生物學(xué)測(cè)試、阻燃測(cè)試和血液穿透測(cè)試通過(guò)的情況下，可以豁免產(chǎn)品上市登記（510K），直接進(jìn)行FDA工廠注冊(cè)和醫(yī)療器械列名。二是如果獲得持有510K的制造商的授權(quán)，可以作為其代工廠使用其510K批準(zhǔn)號(hào)進(jìn)行企業(yè)注冊(cè)和器械列名。個(gè)人防護(hù)口罩需通過(guò)NIOSH注冊(cè)，企業(yè)直接在NIOSH官網(wǎng)申請(qǐng)。
A: medical masks and protective masks are managed separaby in the United States. Among them, medical masks are managed by the U.S. Food and Drug Administration (FDA), while personal protective masks are managed by the National Institute of occupational safety and health (NIOSH). Medical masks need to be registered with FDA, and enterprises directly apply to the FDA website and b relevant materials. In addition, there are two alternative ways: first, N95 masks that have obtained NIOSH registration can be exempted from listing registration (510k) when the biological test, flame retardant test and blood penetration test of the products pass, and FDA factory registration and medical device listing can be conducted directly. Second, if authorized by the manufacturer holding 510k, it can use its 510k approval number as its representative factory for enterprise registration and device listing. Personal protective masks need to be registered with NIOSH, and enterprises directly apply on NIOSH official website.
美國(guó)對(duì)防護(hù)服的準(zhǔn)入要求有哪些？
What are the entry requirements for protective clothing in the United States?
答：美國(guó)對(duì)醫(yī)用防護(hù)服和個(gè)人防護(hù)服的管理也類(lèi)似于口罩的管理方式，其中醫(yī)用防護(hù)服由美國(guó)食品藥品監(jiān)督管理局（FDA）管理，而個(gè)人防護(hù)服由美國(guó)國(guó)家職業(yè)安全衛(wèi)生研究所（NIOSH）管理。企業(yè)直接在FDA或NIOSH進(jìn)行注冊(cè)申請(qǐng)。
A: the management of medical protective clothing and personal protective clothing in the United States is similar to the management of masks. The medical protective clothing is managed by the U.S. Food and Drug Administration (FDA), while the personal protective clothing is managed by the National Institute of occupational safety and health (NIOSH). Enterprises directly apply for registration in FDA or NIOSH.
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