口罩防疫用品欧盟ce认证应急预案法规PPE-R/02.075已发布

欧盟针对口罩防疫急需物资，应急预案法规PPE-R/02.075已颁布。中国口罩厂家可在欧盟有PPE法规授权，呼吸防护系统产品类别认证授权，且有自己测试实验室的公告号机构进行应急预案的测试和认证，大大缩短认证周期。

 

所有国内实验室均无测试认证资质。

 

此种防护口罩CE认证为疫情条件下的CE认证特殊处理，证书与正规流程的CE证书拥有同等效力，可清关和在欧盟市场流通，只是仅限疫情期间使用。疫情结束后，如果中国厂家想继续在欧盟市场销售，必须重新按照EN149正规流程在欧盟NB机构重新测试认证。

 

应急预案法规PPE-R/02.075 Filtering half mask to protect against COVID-19是在EN149的基础上颁发的新的测试认证标准。

 

相关文章：

EN 149: 2001+A1: 2009

口罩ce认证

 

According to Commission Recommendation (EU) 2020/403 of 13 March 2020 paragraph 3 and 4 and actual WHO recommendations, FFP2 or equivalent filtering half-masks can be used for protection against SARS-CoV-2.

For EU type examination (annex V – module B – PPE regulation 2016/425):

If the manufacturer claims a general protection against particles, EN 149:2001+A1:2009 shall be used.

If the manufacturer claims protection against SARS-CoV-2 only:

- Requirements of EN 149:2001+A1:2009 class FFP2 modified as below can be used.

- Other international standards could be study by notified bodies. These standards should be used in respect with EHSR and other requirements of the PPE regulation 2016/425. In particular, markings and information for use shall be clear regarding the special use against SARS-CoV-2.

 

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