產(chǎn)品詳情
歐盟對防護服的準入要求有哪些？
What are the access requirements of EU for protective clothing?
答：防護服分為醫(yī)用防護服和個人防護服，管理要求與口罩基本類似。醫(yī)用防護服按照醫(yī)療器械管理，其中無菌醫(yī)用防護服需按照歐盟醫(yī)療器械指令93/42/EEC（MDD）或歐盟醫(yī)療器械條例EU2017/745（MDR）獲得CE認證，非無菌醫(yī)用防護服只需進行CE自我聲明。個人防護服需按照歐盟個人防護設備條例EU2016/425（PPE）獲得CE認證。
歐盟口罩、防護服等防疫物資CE認證公告機構在哪里查詢？
答：歐盟醫(yī)療器械指令93/42/EEC（MDD）授權的公告機構查詢地址：
歐盟醫(yī)療器械條例EU 2017/745（MDR）授權的公告機構查詢地址：
歐盟個人防護裝備條例EU2016/425（PPE）授權的公告機構查詢地址：
A: the protective clothing is divided into medical protective clothing and personal protective clothing. The management requirements are basically similar to those of masks. Medical protective clothing is managed according to medical devices. Sterile medical protective clothing shall obtain CE certification according to EU medical device directive 93 / 42 / EEC (MDD) or EU medical device regulation eu2017 / 745 (MDR). Non sterile medical protective clothing only needs CE self declaration. Personal protective clothing shall be CE certified in accordance with the EU personal protective equipment regulation eu2016 / 425 (PPE).
Where is the CE certification body for EU respirators, protective clothing and other epidemic prevention materials?
Answer: inquiry address of notified body authorized by EU medical device directive 93 / 42 / EEC (MDD):
Inquiry address of notified body authorized by EU medical device regulation EU 2017 / 745 (MDR):
Inquiry address of the notified body authorized by EU personal protective equipment regulation eu2016 / 425 (PPE):
李國杰（經(jīng)理）：18202125732
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