消毒盒怎么办理CE认证

单价: 1000.00元/件
发货期限: 自买家付款之日起 天内发货
所在地: 广东 深圳
有效期至: 长期有效
发布时间: 2023-12-14 19:05
最后更新: 2023-12-14 19:05
浏览次数: 51
发布企业资料
详细说明

CE认证所需要提供的资料:

1、制造商(欧盟代表(欧盟代理)AR)的名称,商号,地址;

2、产品的型号,编号;

3、产品使用说明书;

4、安全设计文件(关键结构图,即能反映爬申距离、间隙、绝缘层数和厚度的设计图);

5、产品技术条件(或企业标准);

6、产品电原理图;

7、产品线路图;

8、关键元部件或原材料清单;

9、测试报告(Testing Report);

10、欧盟认证机构NB出具的相关证书(对于模式A以外的其它模式);

11、产品在欧盟境内的注册证书(对于某些产品比如:Class I医疗器械,普通IVD体外诊断医疗器械);

12、CE符合声明(DOC)。

消毒盒CE认证办理流程:

1.企业向机构提交办理CE认证的申请表,提供产品的资料并寄样;

2.机构根据企业提供的资料来判定产品对应的欧盟指令和测试标准,测试周期以及费用;

3.企业确认报价后,签订技术服务合同并支付费用;

4.机构工程师根据欧盟检测标准对产品进行整套测试及相关型号的差异性测试,然后编写技术文档(TCF),提交欧盟机构审核;

5.审核通过,颁发CE证书。ta:image/png;base64,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") center center no-repeat; display: inline-block; vertical-align: top;">


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