欧盟标准 EN 455-1/2/3 标准一次性医用手套测试

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详细介绍

Test or certification item 测试或认证名称:

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

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

Lead time 测试周期: 常规 regular service 45 working days

EN 455 -1, Medical gloves for single use 一次性医用手套, 300个样品, 密封性,针漏测试, 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 一次性医用手套, 180个样品, 老化前后尺寸等物理测试, 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 加速老化前的断裂力  (60pcs)
5.3 - Force at break after accelerated ageing 加速老化后的断裂力 (60pcs)(70度72小時)

EN 455 -3, Medical gloves for single use 一次性医用手套, 400个样品, 生物学评价, 4-6weeks
Medical gloves for single use－Part 3: Requirements and testing for biological evaluation
4.1 - ISO10993动物测试报告需要企业额外提供,或者企业向我司额外申请
4.2 - Chemicals (ISO 10993-17 leachable residual chemicals),此節是製造商需向申请机构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可移动表面粉末的测定 (for powder free glove only只测声称无表面粉末的手套) EN ISO 21171(100pcs)
4.5 - Proteins, leachable 可浸出蛋白质 (for gloves containing natural rubber latex只测声称天然乳胶的手套) (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

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