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欧盟CE认证标准EN 455-4《一次性医用手套 - 第 4 部分:保质期测定的要求和测试》


标准编号 Standard/Code标准名称 Standard Title
EN 455-4Medical gloves for single use - Part 4: Requirements and testing for shelf life determination


for labelling and the disclosure of information relevant to the test methods used. This European Standard applies to existing, new and significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period of time. This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.

用于标签和披露与所用测试方法相关的信息。 本欧洲标准适用于现有的、新的和显着改变的设计。 当前没有可用老化数据的现有设计应在合理的时间内生成该数据。 该欧洲标准没有指定批次的大小。 人们注意到与大批量的分配和控制相关的困难。 建议的最大单批生产量为 500 000 件。

Test Requirement 测试要求:

一次性医用手套.测定货架寿命的要求和试验

Sample Size 样品数量 / 送样规格: 300pcs
Lead Time / TAT (Turn Around Time) 测试周期: 常规服务 Regular service 45 working days

Report Summary 报告摘要:

 

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