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EN 13795 外科手術(shù)用鋪巾、手術(shù)衣及無塵衣
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對應法規(guī)：EN 13795
CNAS認可項目：是 Test item 測試名稱: Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment
外科手術(shù)用鋪巾、手術(shù)衣及無塵衣
Norm refer 涉及標準: YY/T 0506
Test info 測試內(nèi)容:
EN 13795 - For critical area 關(guān)鍵區(qū) EN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment
外科手術(shù)用鋪巾、手術(shù)衣及無塵衣 - Resistance to microbial penetration - Wet 阻菌-濕態(tài), 30WD, EN ISO 22610
1.樣品需滅菌；獨立包裝
2. 請確認測試在哪一面進行
250mm x 250mm x 5pcsEN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment
外科手術(shù)用鋪巾、手術(shù)衣及無塵衣 - Cleanliness - Microbial 微生物清潔度 ISO 11737-1
1.樣品需滅菌；獨立包裝
2. 請確認測試在哪一面進行
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
外科手術(shù)用鋪巾、手術(shù)衣及無塵衣 - Cleanliness - Particulate Matter & Lihting 清潔度-顆粒物質(zhì)與液體 ISO 13795 / ISO 9073-10
1.樣品需滅菌；獨立包裝
2. 請確認測試在哪一面進行
220mm x 285mm x 20pcsEN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment
外科手術(shù)用鋪巾、手術(shù)衣及無塵衣 - Resistance to liquid penetration 靜水壓測試, 30WD, EN 20811
獨立包裝，如果使用時要滅菌，請送滅菌樣品
200mm x 200mm x 5pcsEN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment
外科手術(shù)用鋪巾、手術(shù)衣及無塵衣 - Bursting strength - Dry 爆破強度-干態(tài), 30WD, EN ISO13938-1
獨立包裝，如果使用時要滅菌，請送滅菌樣品
150mm x 150mm x 5pcsEN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment
外科手術(shù)用鋪巾、手術(shù)衣及無塵衣 - Bursting strength - Wet 爆破強度-濕態(tài), 30WD, EN ISO13938-1
獨立包裝，如果使用時要滅菌，請送滅菌樣品
150mm x 150mm x 5pcsEN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment
外科手術(shù)用鋪巾、手術(shù)衣及無塵衣 - Tensile strength - Wet 拉伸強度-濕態(tài), EN 29073-3
獨立包裝，如果使用時要滅菌，請送滅菌樣品
350mm x 50mm x 10pcsEN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment
外科手術(shù)用鋪巾、手術(shù)衣及無塵衣 - Tensile strength - Dry 拉伸強度-干態(tài), EN 29073-3
獨立包裝，如果使用時要滅菌，請送滅菌樣品
350mm x 50mm x 10pcsEN 13795 - For less critical area 非關(guān)鍵區(qū) EN 13795,Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment
外科手術(shù)用鋪巾、手術(shù)衣及無塵衣 - Resistance to microbial penetration - Dry 阻菌-干態(tài), 30WD, EN ISO 22612
1.樣品需滅菌；獨立包裝
2. 請確認測試在哪一面進行
200mm x 200mm x 12pcsEN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment
外科手術(shù)用鋪巾、手術(shù)衣及無塵衣 - Cleanliness - Microbial 微生物清潔度 ISO 11737-1
1.樣品需滅菌；獨立包裝
2. 請確認測試在哪一面進行
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
外科手術(shù)用鋪巾、手術(shù)衣及無塵衣 - Cleanliness - Particulate Matter & Lihting 清潔度-顆粒物質(zhì)與液體 ISO 13795 / ISO 9073-10
1.樣品需滅菌；獨立包裝
2. 請確認測試在哪一面進行
220mm x 285mm x 20pcsEN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment
外科手術(shù)用鋪巾、手術(shù)衣及無塵衣 - Resistance to liquid penetration 靜水壓測試, 30WD, EN 20811
獨立包裝，如果使用時要滅菌，請送滅菌樣品
200mm x 200mm x 5pcsEN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment
外科手術(shù)用鋪巾、手術(shù)衣及無塵衣 - Bursting strength - Dry 爆破強度-干態(tài), 30WD, EN ISO13938-1
獨立包裝，如果使用時要滅菌，請送滅菌樣品
150mm x 150mm x 5pcsEN 13795, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment
外科手術(shù)用鋪巾、手術(shù)衣及無塵衣 - Tensile strength - Dry 拉伸強度-干態(tài), EN 29073-3
獨立包裝，如果使用時要滅菌，請送滅菌樣品
350mm x 50mm x 10pcsLead time 測試周期: Regular 常規(guī) 35 working days
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