Understanding Harmonized Standards and CE Marking

CE标记介绍

The CE Mark allows manufacturers to import and export their products freely within the European Union, with common product design and manufacturing requirements defined within EU directives and/or regulations. By placing the mandatory conformity mark on a product, manufacturers are providing a clear indication that it meets all the requirements of relevant CE marking directive/regulation and therefore should enable free movement within the EU.

CE标记适用于许多不同的产品类别，从电气设备到爆炸物和从玩具到医疗设备。每种产品都属于一个或多个指令或法规，其确定产品必须满足的特定要求是CE标记。制造商负责确保产品遵从性并将CE标记放在产品上，然后放在市场上。

The CE Mark does not represent a product has undergone safety testing but rather is a self-declaration from the manufacturer that it meets the directives and regulations that apply to it, thereby achieving one of the EU’s primary objectives of a single market. To achieve this, the manufacturer must carry out a full risk assessment of the product against the ‘essential requirements’ of the directive/regulation. The initial stage of this assessment, the risk analysis, is the process of identifying all the potential hazards associated with the product and the environment in which it is going to be used.

Many of the hazards identified in a risk assessment will be covered by the application of one or more applicable harmonized standards; European standards that have been developed by a recognized European Standards Organisation and cited in the Official Journal of the European Union (OJEU).

符合性的推定

By testing to a harmonized standard or standards, published in the OJEU, manufacturers can demonstrate that a product complies with the essential requirements of the directive and gain a ‘presumption of conformity’.

作为该过程的一部分，制造商负责仔细考虑对适用指令的基本要求的每个潜在危害，并能够提供明确的证据。这包括考虑到使用而且潜在滥用产品。

Whilst the duty to carry out a full risk analysis lies with the manufacturer; Element’s experts can provide in-depth advice and support in working through the details of the risk analysis. Each risk identified must have its impact assessed, termed a risk evaluation. This evaluation, combined with the risk analysis, is the risk assessment.

如果评估发现风险很高，则需要额外的行动来将风险降低到更可接受的水平。这可以通过执行额外的测试来模拟风险或修改产品的设计以消除危险的额外测试来完成。

选择和应用最合适的协调标准

As not all hazards will necessarily be covered in this process, the application of a harmonized standard on its own is not always sufficient for demonstrating compliance. The manufacturer must select and apply the most appropriate harmonized standard, assess if the standard is fully adequate for the product and its environment, and also determine if the product requires additional tests before it can be placed on the market.

统一标准的参考资料在Ojeu发布，制造商应在选择适当的协调标准时使用作为第一个呼叫点来测试产品。但是，由于对最新和最相关标准的测试至关重要，通常要求制造商在Ojeu Journal中查阅其他适用标准的其他地方。etsi和cenelec等标准组织在这个阶段非常宝贵，因为他们提供了对未来标准的工作洞察，这可能包括确定以前不考虑的新危害。

值得注意的是，使用统一标准是CE标志的两个主要路线之一，在大多数指令中，它是完全自愿的，制造商能够决定其产品的最佳路线，并选择优先履行基本要求的其他方式。

如果第3.2条方面没有统一标准（RF特征），则必须转到通知机构以进行类型检查证明。这是通知机构独立评估所做的内容的地方，检查技术文件是否正确编译，并以表明已满足指令的基本要求的方式呈现。应该指出的是，制造商希望使用TEC路由可能还有其他原因，包括确认他们已应用正确的标准。

If the manufacturer is using standards that are not listed in the OJEU then they must not forget to add additional time to the compliance process if they are using a Notified Body. While using a Notified Body will inevitably add time to market, it also identifies administrative mistakes that may be picked up by market surveillance authorities later on.

Ensuring ongoing compliance

As new technologies and hazards are identified, harmonized standards evolve and are either amended or revised accordingly. Therefore, it is vital that manufacturers understand their duty to ongoing compliance for their products and keep fully informed of any changes to their product’s relevant standards. When a standard is updated, there would normally be a transitional period where a manufacturer has time to upgrade their compliance information with results from the new standard before the previous version is withdrawn from the OJEU and presumption of conformity is no longer justified.

考虑到第一个设计过程中的CE标记

由于各个标准的要求，尤其是在同时施用时，实现遵守CE标志可能是复杂的过程。每个标准都有一个范围，详细描述了它适用的产品类型。范围通常是对解释的，这可能会为试图确定适用于其产品的标准的制造商产生混淆。此外，对于某些产品类型通常通常与其他立法和特定的排除重叠。

Unless a manufacturer has a comprehensive understanding of their responsibilities and how to meet them, they must seek expert advice to reduce ambiguity on CE marking requirements.

作为通知机构，元素可以通过相关的测试过程提供专家指导来支持产品。制造商在产品开发过程结束时首次达到元素，开始讨论CE测试，但现实情况是，在没有先前的预见到测试或规格之前，产品将是幸运的。为了获得成功的结果，如果在产品的生命周期早期谈话开始，则更容易更容易，以便可以从第一个设计过程中建立在产品之一内建立在产品中所需的任何必需的设计要求。这不仅可以防止延迟，而且可以防止与产品修改相关的大量成本。

If you would like to find out more about CE marking a device or request a quote, pleasecontact us today.