欧盟标准 EN 13795 外科手术用铺巾、手术衣及无尘衣测试
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 |
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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 |
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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. |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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. |
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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 |
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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 20 working days
Others 其他:
Sample report 样本报告：
Photo for reference 参考图片：
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