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本帖最后由 violet112900 于 2023-4-21 09:42 编辑
1. 技术文件是证明产品安全和合规性的文件汇编
The technical file is the compilation of documents that manufacturer must demonstrate the evidence that they have done the necessary tasks their product is safe and complices with all applicable EU legislation.
清单如下：
Risk assessment（(pre-production assessment)）风险评估
A general description of the product, variants, and intended use相关产品、类似产品及其预期用途的基本描述(4 items about the product)
Construction drawings结构图
Explanations for the above上述内容的说明
Results of calculations and investigations计算的结果和调研(if have)
Test reports for all applicable directive.
所有适用指令的检测报告,电子电器产品为例：LVD,EMC,RoHS,ERP.
A list of the harmonised standards and other technical specifications that have been applied
一份使用的协调标准和其他技术规范的列表
A dated and signed copy of the EU Declaration of Conformity一份标注了日期并签名的欧盟符合性声明
A copy of the marking plate and the user instructions用户手册和产品铭牌的副本
A description of the production control measures that the manufacturer has implemented
一份制造商实施的生产控制方法的说明
2.《符合性声明》是指制造商声明产品符合所有适用的欧盟法律法规，这是欧盟产品安全计划中最重要的文件，如果你想要在欧盟市场上销售加贴了CE标志的产品，你必须起草一份《符合性声明》,否则，销售是违法的。
The Declaration of Conformity is the manufacturer's declaration that the product complies with all applicable EU legislation and it takes full responsibility for the products.
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技术文件是证明产品安全和合规性的文件汇编
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