{:en}Compliance{:}{:zh}符合性{:}
{:en}The manufacturer or supplier should use one of the product conformity assessment modules available within the directive to demonstrate that the product complies with the essential requirements. One of the most common options for product assessment is to apply the relevant standards to the product and/or prepare relevant documentation such as the Technical File. The CE Marking should be affixed legibly and indelibly to the product. The manufacturer should also prepare and sign a ‘Declaration of Conformity.’
Many of the CE Marking Directives include provision for the appointment of Notified Bodies. These are organizations appointed by the Member States in which they are based. Their details are ‘notified’ to the European Commission, who then publish these details in the Official Journal of the European Communities.
The specific functions of Notified Bodies regarding compliance assessment for specific products are defined by the directives. For most, the involvement of a Notified Body is only required for high-risk and safety-critical products.
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{:}{:zh}制造商或供应商应使用一个指令内的产品符合性评估模块,以证明该产品符合基本要求。产品评估的最常见的选择之一是将相关标准应用于产品和/或准备相关的文档,如技术文件。CE标志应在产品上标示清楚并不可磨灭。制造商也应该准备和签署一个“符合性声明”。
许多CE标志指令包括通知机构的委任条款。这些组织是由他们所在的成员国任命的。他们的细节 已经“通告”了欧洲委员会,欧洲委员会就会在欧洲社区的官方杂志上公布这些细节。
通知机构对特定产品的合规性评估的具体功能是由指令定义的。通常来说,通知机构的参与通常只涉及高风险和安全关键产品。
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