TÜV南德CE认证：博辉瑞进一次性医用防护服-BH800（Medical Protective Coverall BH800）

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

第二类医疗器械注册证：京械注准20202140241

China Class II Medical Device Registration Certificate: 京械注准20202140241

产品分类：无菌、非无菌

Product Classification: Sterile/Non-sterile

适用范围：非无菌产品可用于隔离留观病区（房）、隔离病区（房）医护人员穿的职业防护衣。阻止来自患者的病毒随空气或液体向医务人员传播。

无菌产品适用于隔离重症监护病区（房）医护人员穿的职业防护衣，阻止来自患者的病毒随空气或体液向医务人员传播。

Typical applications:

Medical Protective Coverall-BH800（Non-sterile） is used to provide barrier and protection for the blood, body fluids, secretions, and particles in the air of patients with potential infection that the clinical medical staff come into contact with at work.

Medical Protective Coverall-BH800（Sterile）is used to provide barrier and protection for the blood, body fluids, secretions, and particles in the air of patients with potential infection that the intensive care unit staff come into contact with at work.

一次性医用防护服-BH800

Medical Protective Coverall BH800

一次性医用防护服-产品性能

主要材质：采用78g/㎡复合型非织造布为原料，由一种或多种对病毒气溶胶、含病毒液体等具有隔离作用的面料，经裁剪缝纫加工而成。

防护性能：外覆防护服专用热封胶带,有效阻隔病毒、细菌、有害超细粉尘、体液血液喷溅。

防静电性能：材质经过抗静电处理，减少有害物质吸附。

Main material: Composite nonwoven fabric of 78g/㎡ is used as raw material, and it is made by cutting and sewing one or more fabrics that can isolate virus aerosols and virus-containing liquids.

Protection performance: Seams are covered with special heat-sealing tape for extra protection. The tape can effectively block viruses, bacteria, harmful ultrafine dust, and body fluids and blood splashes.

Anti-static performance: The material is treated with anti-static treatment, which can effectively reduce the adsorption of harmful substances.

一次性医用防护服BH800-证书明细

ISO 13485证书

ISO 13485 QMS Certificate