李国杰（经理）：18202125732 电话：021-61062636
欧盟对防护服的准入要求有哪些？
What are the access requirements of EU for protective clothing?
答：防护服分为***防护服和个人防护服，管理要求与口罩基本类似。***防护服按照***器械管理，其中无菌***防护服需按照欧盟***器械指令93/42/EEC（MDD）或欧盟***器械条例EU2017/745（MDR）获得CE认证，非无菌***防护服只需进行CE自我声明。个人防护服需按照欧盟个人防护设备条例EU2016/425（PPE）获得CE认证。
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 needs to 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).
欧盟口罩、防护服等防疫物资CE认证公告机构在哪里查询？
Where is the CE certification body for EU respirators, protective clothing and other epidemic prevention materials?
答：欧盟***器械指令93/42/EEC（MDD）***的公告机构查询地址：
欧盟***器械条例EU 2017/745（MDR）***的公告机构查询地址：
欧盟个人防护装备条例EU2016/425（PPE）***的公告机构查询地址：
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):
李国杰（经理）：18202125732 电话：021-61062636
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