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      TüV南德CE認證:博輝瑞進手術衣-BH600(Medical Surgical Gowns(Standard)-BH600)


      作者:本站編輯    發布日期:2021-01-04

      南德 TüV CE證書編號:No. G2S 101395 0003 Rev.00

      TüV SüD CE certificate:No.G2S 101395 0003 Rev.00


      產品分類:無菌、非無菌

      Product Classification: Sterile/Non-sterile

       

      適用范圍:用于穿在手術醫護人員身上,起到防止醫生身體上的皮屑彌散到開放的手術創面和手術病人的體液向醫務人員傳播,起到雙向生物防護的作用。

      Typical applications:

      Medical Surgical Gowns (Standard)-BH600 is used to wear on the surgical medical staff to prevent the scurf on the doctor's body from spreading to the open surgical wound and the body fluid of the surgical patient to spread to the medical staff, playing a two-way biological protection role.


      手術衣-BH600

      Medical Surgical Gowns(Standard)-BH600




      手術衣BH600-產品性能





      主要材質:采用45g/㎡SMS復合非織造布為原料,超聲焊接工藝,保證手術衣具有良好的抗滲透性能,布料柔軟、舒適、透氣。


      防護性能對細菌和液體有高阻隔性,能有效阻隔細菌和微生物穿透。


      拉伸強度和撕裂強度高,不易起毛掉屑。


      Main material:

      SMS composite nonwoven fabric of 45g/㎡ is used as raw material. It is soft, comfortable, breathable. Ultra-sonic seam instead of single/double needle line is used, which ensures that the surgical gown has good anti-permeability.

       

      Protection performance:

      It has high barrier properties to bacteria and liquids, and can effectively block the penetration of bacteria and microorganisms.

       

      It has high tensile strength and tear strength, and is not easy to hair and chip.


      手術衣BH600-證書明細


       ISO  13485證書 

      ISO  13485 QMS Certificate 


       CE證 

      CE Certificate 

       無菌符合性聲明DOC 

      Sterile DOC 

       非無菌符合性聲明 DOC

      Non-sterile DOC  

       歐盟登記注冊 

      EU registration Certificate 



       EN 13795 檢測報告 

       EN 13795 Test Report 

       AAMI PB70 檢測報告 

       AAMI PB70 Test Report 



       Reach 檢測報告 

       Reach  Report 




       生物相容性檢測報告 

       Biocompatibility Test  Report 


       企業海關出口資質 

       Customs qualification 



       醫療器械生產許可證 

       Production License  


      010-61252660

      北京博輝瑞進生物科技有限公司

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