歐盟標準 EN 455-1/2/3 標準一次性醫用手套測試

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詳細介紹

Test or certification item 測試或認證名稱:

EN 455 -1/2/3, Medical gloves for single use 一次性醫用手套, test report

EN 455 -1/2/3, Medical gloves for single use 一次性醫用手套, test report + CoC certificate

Lead time 測試周期: 常規 regular service 45 working days

EN 455 -1, Medical gloves for single use 一次性醫用手套, 300個樣品, 密封性,針漏測試, 4weeks
Medical gloves for single use－Part 1: Requirements and testing for freedom from holes
5 - Watertightness test for detection of holes(300pcs)

EN 455 -2,  Medical gloves for single use 一次性醫用手套, 180個樣品, 老化前后尺寸等物理測試, 4weeks
Medical gloves for single use－Part 2: Requirements and testing for physical properties
4.2  - Length&Width 老化前尺寸 (60pcs)
5.2  - Force at break before accelerated ageing 加速老化前的斷裂力  (60pcs)
5.3 - Force at break after accelerated ageing 加速老化后的斷裂力 (60pcs)(70度72小時)

EN 455 -3, Medical gloves for single use 一次性醫用手套, 400個樣品, 生物學評價, 4-6weeks
Medical gloves for single use－Part 3: Requirements and testing for biological evaluation
4.1 - ISO10993動物測試報告需要企業額外提供,或者企業向我司額外申請
4.2 - Chemicals (ISO 10993-17 leachable residual chemicals),此節是製造商需向申請機構揭露他用了哪些化學物質,非測試項目
4.3 - Endotoxins 內毒素 (100pcs)
4.4 - Powder可移動表面粉末的測定 (for powder free glove only只測聲稱無表面粉末的手套) EN ISO 21171(100pcs)
4.5 - Proteins, leachable 可浸出蛋白質 (for gloves containing natural rubber latex只測聲稱天然乳膠的手套) (100pcs)
4.6 - Labelling 產品標示 (EN 1041:2008 ; EN ISO 15223-1:2012, 蛋白質標示) (100pcs)
4.3~4.5的檢測100pcs樣品僅可產生10筆數據 ,非100筆數據

Others 其他信息:

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