Understanding Harmonized Standards and CE标志

Introduction to CE标志 

The CE标志 allows manufacturers to import and export their products freely within the 欧洲an Union, with common product design and manufacturing requirements defined within EU directives and/or regulations. By placing the mandatory conformity mark on a product, 制造商提供明确的指示，表明其符合相关CE标志指令/法规的所有要求，因此应该能够在欧盟内自由流通. 

CE marking applies to numerous different product categories, ranging from electrical equipment to explosives and from toys to medical devices. Each product falls under one or more directives or regulations, which determine the specific requirements that the product must meet to be CE-marked. 制造商有责任确保产品符合要求，并在产品投放市场之前将CE标志贴在产品上. 

CE标志并不代表产品经过了安全测试，而是制造商的一种自我声明，表明产品符合适用于该产品的指令和法规, thereby achieving one of the EU’s primary objectives of a single market. 为了实现这个目标, 制造商必须根据指令/法规的“基本要求”对产品进行全面的风险评估. The initial stage of this assessment, 风险分析, 识别与产品及其使用环境相关的所有潜在危害的过程是否存在. 

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

Presumption of conformity

By testing to a harmonized standard or standards, published in the OJEU, 制造商可以证明产品符合指令的基本要求，并获得“符合性推定”。. 

As part of the process, 制造商有责任根据适用指令的基本要求仔细考虑每种潜在危害，并能够提供明确的证据证明已经这样做了. This includes considering not only the use but also potential misuse of the product.  

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

If the assessment finds that the risk is high, additional action is then required to reduce the risk to a more acceptable level. 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来消除危险来实现.

Selecting and applying the most appropriate harmonized standard

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.

The references of harmonized standards are published in the OJEU, 当选择适当的协调标准来测试产品时，制造商应该首先使用哪个标准. 然而, as testing to the latest and most relevant standards is vital, 它通常要求制造商在其他地方查看尚未在OJEU期刊上发表的更适用的标准. 像ETSI和CENELEC这样的标准组织在这个阶段是无价的，因为他们提供了对未来标准工作的见解，这些标准可能包括识别以前没有考虑到的新危害. 

It is worth noting that using harmonized standards is one of the two main routes to CE marking, 在大多数指令中，它完全是自愿的，制造商可以决定他们产品的最佳路线，并选择其他方式来满足基本要求.

If there are no harmonized standards for article 3.2个方面(射频特性)，那么必须去公告机构获得型式检验证书. This is where the Notified Body independently assesses what has been done, 检查技术文件是否正确编制，并以显示已符合指示的基本要求的方式提交. It should be noted that there may be other reasons why a manufacturer wishes to use the TEC route, including confirmation that they have applied the right standards.

如果制造商使用的是OJEU中未列出的标准，那么如果他们使用公告机构，他们一定不要忘记在合规过程中增加额外的时间. 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. 因此, 至关重要的是，制造商了解他们的责任，持续遵守他们的产品，并充分了解他们的产品相关标准的任何变化. When a standard is updated, 通常会有一个过渡期，在旧版本从OJEU中撤回之前，制造商有时间根据新标准的结果升级其合规性信息，并且不再有理由推定合规性.

Considering CE marking from day one of the design processes 

由于各个标准的要求不同，获得CE标志的合规性可能是一个复杂的过程, especially when applied simultaneously. Each standard has a scope, which describes in detail the types of products to which it applies. 该范围通常有多种解释，这可能会给试图决定哪些标准适用于其产品的制造商造成混淆. Also, there are often overlaps with other legislation and specific exclusions for some product types. 

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. 

作为公告机构, im体育APP can provide expert guidance to support products through the relevant testing process. 制造商通常在产品开发过程结束时第一次与im体育APP联系，开始讨论CE测试, but the reality is that a product would be lucky to pass with no prior foresight into the tests or specifications. To have a successful outcome, 如果在产品生命周期的早期开始对话，那么从设计过程的第一天开始，就可以将满足适用标准所必需的任何设计需求构建到产品中，这将容易得多. 这不仅可以防止延误，还可以防止与产品修改相关的重大成本.

If you would like to find out more about CE marking a device or request a quote, please 立即im体育APP.