出口欧洲Export to Europe

测试产品：个人防护口罩 、医用口罩

Test products: personal protective masks, medical masks

主要测试项目：性能测试、生物学测试、呼气阻力、呼气阀泄露、过滤效率等。

Main test items: performance test, biological test, exhalationresistance, exhalation valve leakage, filtration efficiency,etc.

标准依据 Standard basis

医用口罩：EN14683标准，按欧盟医疗器械指令93/42/EEC（MDD）或欧盟医疗器械条例EU2017/745（MDR）加贴CE标志。

Medical masks: EN14683 standard, according to the European UnionMedical Device Directive 93/42/EEC (MDD) or the European UnionMedical Device Regulations EU2017/745 (MDR) with the CE mark.

（1）无菌医用口罩：必须由授权公告机构进行CE认证。

(1) Sterile medical masks: CE certification must be carried outby an authorized announcement agency.

（2）非无菌医用口罩：企业只需进行CE自我符合性声明，不需要通过公告机构认证。在准备好相应文件及测试报告等资料后，即可自行完成符合性声明。

(2) Non-sterile medical masks: enterprises only need to make CEself-conformity declaration, and do not need to pass thecertification of the notified body. After preparing the relevantdocuments and test reports, you can complete the declaration ofconformity yourself.

个人防护口罩：EN149标准，需要符合欧盟个人防护设备条EU2016/425（PPE）要求，由授权公告机构进行CE认证并颁发证书。

Personal protective masks: EN149 standard, which needs to meetthe requirements of EU Personal Protective Equipment ArticleEU2016/425 (PPE), and CE certification and certification will beissued by an authorized announcement