TÜV南德CE认证:博辉瑞进手术衣-BH600(Medical Surgical Gowns(Standard)-BH600)


作者:本站编辑    发布日期:2021-01-04

南德 TÜV CE证书编号:No. G2S 101395 0003 Rev.00

TÜV SÜD CE certificate:No.G2S 101395 0003 Rev.00


产品分类:无菌、非无菌

Product Classification: Sterile/Non-sterile

 

适用范围:用于穿在手术医护人员身上,起到防止医生身体上的皮屑弥散到开放的手术创面和手术病人的体液向医务人员传播,起到双向生物防护的作用。

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.


手术衣-BH600

Medical Surgical Gowns(Standard)-BH600




手术衣BH600-产品性能





主要材质:采用45g/㎡SMS复合非织造布为原料,超声焊接工艺,保证手术衣具有良好的抗渗透性能,布料柔软、舒适、透气。


防护性能对细菌和液体有高阻隔性,能有效阻隔细菌和微生物穿透。


拉伸强度和撕裂强度高,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.


手术衣BH600-证书明细


 ISO  13485证书 

ISO  13485 QMS Certificate 


 CE证 

CE Certificate 

 无菌符合性声明DOC 

Sterile DOC 

 非无菌符合性声明 DOC

Non-sterile DOC  

 欧盟登记注册 

EU registration Certificate 



 EN 13795 检测报告 

 EN 13795 Test Report 

 AAMI PB70 检测报告 

 AAMI PB70 Test Report 



 Reach 检测报告 

 Reach  Report 




 生物相容性检测报告 

 Biocompatibility Test  Report 


 企业海关出口资质 

 Customs qualification 



 医疗器械生产许可证 

 Production License  


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