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  • EN 13795 外科手术用铺巾、手术衣及无尘衣

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  • 对应法规:EN 13795
    CNAS认可项目:是
  •  

    Test item 测试名称:  Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment

    外科手术用铺巾、手术衣及无尘衣

     

    Norm refer 涉及标准: YY/T 0506

     

    Test info 测试内容:

    EN 13795 - For critical area  关键区
    EN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment 
    外科手术用铺巾、手术衣及无尘衣 - Resistance to microbial penetration - Wet 阻菌-湿态, 30WD, EN ISO 22610
    1.样品需灭菌;独立包装
    2. 请确认测试在哪一面进行
    250mm x 250mm x 5pcs
    EN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment 
    外科手术用铺巾、手术衣及无尘衣 - Cleanliness - Microbial 微生物清洁度 ISO 11737-1
    1.样品需灭菌;独立包装
    2. 请确认测试在哪一面进行
    100mm x 100mm x 2pcs
    Only for facultative, non-fastidious, aerobic bacteria, Yeasts and moulds. And for 3 test pcs each.
    EN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment 
    外科手术用铺巾、手术衣及无尘衣 - Cleanliness - Particulate Matter & Lihting 清洁度-颗粒物质与液体 ISO 13795 / ISO 9073-10
    1.样品需灭菌;独立包装
    2. 请确认测试在哪一面进行
    220mm x 285mm x 20pcs
    EN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment 
    外科手术用铺巾、手术衣及无尘衣 - Resistance to liquid penetration 静水压测试, 30WD, EN 20811
    独立包装,如果使用时要灭菌,请送灭菌样品
    200mm x 200mm x 5pcs
    EN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment 
    外科手术用铺巾、手术衣及无尘衣 - Bursting strength - Dry 爆破强度-干态, 30WD, EN ISO13938-1
    独立包装,如果使用时要灭菌,请送灭菌样品
    150mm x 150mm x 5pcs
    EN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment 
    外科手术用铺巾、手术衣及无尘衣 - Bursting strength - Wet 爆破强度-湿态, 30WD, EN ISO13938-1
    独立包装,如果使用时要灭菌,请送灭菌样品
    150mm x 150mm x 5pcs
    EN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment 
    外科手术用铺巾、手术衣及无尘衣 - Tensile strength - Wet 拉伸强度-湿态, EN 29073-3
    独立包装,如果使用时要灭菌,请送灭菌样品
    350mm x 50mm x 10pcs
    EN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment 
    外科手术用铺巾、手术衣及无尘衣 - Tensile strength - Dry 拉伸强度-干态, EN 29073-3
    独立包装,如果使用时要灭菌,请送灭菌样品
    350mm x 50mm x 10pcs
    EN 13795 - For less critical area  非关键区
    EN 13795,Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment 
    外科手术用铺巾、手术衣及无尘衣 - Resistance to microbial penetration - Dry 阻菌-干态, 30WD, EN ISO 22612
    1.样品需灭菌;独立包装
    2. 请确认测试在哪一面进行
    200mm x 200mm x 12pcs
    EN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment 
    外科手术用铺巾、手术衣及无尘衣 - Cleanliness - Microbial 微生物清洁度 ISO 11737-1
    1.样品需灭菌;独立包装
    2. 请确认测试在哪一面进行
    100mm x 100mm x 2pcs
    Only for facultative, non-fastidious, aerobic bacteria, Yeasts and moulds. And for 3 test pcs each.
    EN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment 
    外科手术用铺巾、手术衣及无尘衣 - Cleanliness - Particulate Matter & Lihting 清洁度-颗粒物质与液体 ISO 13795 / ISO 9073-10
    1.样品需灭菌;独立包装
    2. 请确认测试在哪一面进行
    220mm x 285mm x 20pcs
    EN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment 
    外科手术用铺巾、手术衣及无尘衣 - Resistance to liquid penetration 静水压测试, 30WD, EN 20811
    独立包装,如果使用时要灭菌,请送灭菌样品
    200mm x 200mm x 5pcs
    EN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment 
    外科手术用铺巾、手术衣及无尘衣 - Bursting strength - Dry 爆破强度-干态, 30WD, EN ISO13938-1
    独立包装,如果使用时要灭菌,请送灭菌样品
    150mm x 150mm x 5pcs
    EN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment 
    外科手术用铺巾、手术衣及无尘衣 - Tensile strength - Dry 拉伸强度-干态, EN 29073-3
    独立包装,如果使用时要灭菌,请送灭菌样品
    350mm x 50mm x 10pcs

     

    Lead time 测试周期: Regular 常规 35 working days

     


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