CE Marking Services

What is “CE Marking”?

Many products that are placed on the single market in the European Economic Area (EEA) (28 EU countries, together with Iceland, Liechtenstein and Norway) contain a marking with the letters ‘CE’ affixed. CE marking is a conformity marking which stands for “Conformité Européene” which literally means “European Conformity”.

CE marking general principles are governed by the Regulation (EC) No 765/2008, which defines the requirements for accreditation and market surveillance relating to the market of products.[1]

The meaning of CE marking is “a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing[2]

This implies that by placing the CE marking on a product, a declaration is made by the concerned manufacturer that he bears the sole responsibility to comply to the applicable health, safety and environmental protection legislation, together with all relevant product legislative requirements before having the product placed in the market. Also, the manufacturer shall ensure validity for the product that is put on the EEA market.

What are the benefits of CE marking?

CE marking is regarded as a “passport” for products to enter and circulate freely within the 30 counties forming part of the EEA.

This facilitated path to European Market entry was brought about by the harmonisation of the product requirements legislation across Europe. This means that once the manufacturer ensures legal compliance to affix the CE marking, products will have access to all different member states of the EEA without the need to adapt to specific and conflicting requirements of different member states of the EEA.

In tandem, implementation of these requirements enhances product safety and reliability, which in turn diminish the risk of customer dissatisfaction and associated liability claims.

Which products require CE marking?

CE marking is mandatory, for all products that need to get access to the EEA market and are covered by the scope of at least one or more European Union harmonised directives (examples are found below). On the contrary, products that are not within the field of application of the European Union harmonised acts are not allowed to be CE marked.

[1] Regulation (EC) No. 765/2008, 9 July 2008

[2] Article 2.20 of Regulation (EC) No. 765/2008, 9 July 2008

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Tuning Fork provides producers based in China with the following services:

1. EU Documentation and Standards Delivery Service.

1.1 EU Product Directives

1.2 European Standards

1.3 Other EU Official Documents

2. Technical Consulting Service

2.1 Technical Advice on Compliance Engineering

2.2 Safety and Risk Assessments

3. Compliance Testing Service

3.1 Pre-compliance testing arrangement

3.2 Full-compliance testing arrangement

4. Technical Documentation Service

4.1 Technical Files (Technical Documentation): guiding to prepare for this document.

4.2 EC Declaration of Conformity: guiding and  preparing this document, in several languages.

5. Labeling and Document Translation: Arrange the translation from English into the official language(s) of every EU member state

5.1 Users Manual and Installation Instructions

5.2 Labeling Advice and Translation

6. European (EEA/EU) Authorised/Authorized Representative Service

6.1 Use of Tuning Fork  Name & Address and offices:

6.2 Product Registration: register products with MDD/IVD products in EEA with the Competent Authority (CA) by acting as a  European Authorised/Authorized Representative.

6.3 Renewal and Update Product Registration: update  product registration information whenever it changes

6.4 Keep Technical Files:

6.5 Legislation Monitoring: monitor and report new developments in European product legislation relevant to products.

6.6 Vigilance and Incident Reporting: assist with product vigilance and incident reporting.

6.7  Product Recalls and Advisory Notices: assist with Product Recalls and the issuing of Advisory Notices

What is the CE Marking Process?

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The CE Marking Process Step by Step.

Phase 1: Identify the applicable EU Directive(s) and harmonised standards

The EU Directive(s) applicable to the product that is intended to the EEA market should be identified, so as to establish whether the product requires CE marking or not.

The product should then is assessed for conformity to the essential requirements in the applicable directive(s) that covers both the design and production phases of that product.

The manufacturer then identifies and implements harmonized European standards that are applicable to the product that is intended for CE marking.

Phase 2: Identify the conformity assessment procedure

Conformity assessment consists of a process that the manufacturer is responsible for carrying out, to demonstrate that the applicable requirements in the EU directives have been fulfilled. This process is laid down under the Decision No 768/2008 EC.

There are eight different conformity assessment procedures called modules (named with letters A to H), some of which have variants. The manufacturer shall choose one or two conformity assessment modules to ensure directive(s) compliance to cover both design and production phases.  The distinct conformity Assessment modules and their descriptions are outlined below.

Phase 3: Conduct a conformity assessment of the product

Each of these modules lay down distinct responsibilities on the manufacturer and determine various routes of conformity depending on the applicable directive(s) and risk classification of the product. In essence, conformity assessment routes include:

  • Assessment of the product by the manufacturer, without third party involvement. This option is applicable in case of low complexity in design and production mechanism and thus the product carries low risk for the public interest (e.g. Module A).
  • Assessment of the product by the manufacturer, together with additional requirement for mandatory audits carried out by a notified body chosen by the manufacturer. Some such modules are based on quality assurance techniques derived from the EN ISO 9000[1] and EN ISO 9001[2] standards (e.g. modules D, E and H). This applies for products with more design complexity and increased public risk when in use.
  • Assessment of the product conducted by a notified body involving services such as product testing and type examination certification issue, together with mandatory audits carried out by a notified body chosen by the manufacturer (e.g. module H). This applies for products where design is complex and risk to user’s safety is very high.

Phase 4: Compilation and maintenance of technical documentation

Following, the achievement of a positive conformity assessment result for your product a technical file needs to be compiled. This consists of a range of technical documentation (e.g. technical descriptions, bills of materials, specifications, test reports, instructions for use and EU declaration of conformity (EU DoC) )that verifies compliance to the EU directive(s) with respect to the design, development and production of the product.

The technical documentation (including the EU declaration of conformity) must be kept for 10 years after the last item of the product has been placed on the market.

Certain directives (such as the council directive 93/42/EEC for medical devices as amended by Directive 2007/47/EC)[3], has a requirement that the manufacturer appoints an authorized representative in the European union, that is in a position to provide the technical file on request of a market surveillance authority.

In addition, certain directives specify that if the manufacturer does not have a registered place of business in the EEA, the name of address of the authorized representative in the European Union should be present on the label, outer packaging and product instructions. [4]

Phase 5: Preparation and maintenance the EU Declaration of conformity

The manufacturer or authorized representative established in the EU must complete and sign an EU declaration of conformity which assumes responsibility for the compliance of the product to the applicable EU directive(s). In terms of content, this declaration contains a list of directives and harmonized European standards that the product is conforming to, product identification, manufacturer and authorized representative name, address and approval.

Phase 6: Product registration in the EU

Certain classes of products such as medical devices, require to be formally registered in EEC and then there is a certificate of registration issued.

Phase 7: Affix CE mark on product and/or packaging

CE marking must be affixed to the product in a legible and indelible manner or to its packaging if it is not possible on account of the nature of the product. Also, the CE marking must be affixed to any documentation accompanying the product. CE marking should not be affixed on the product in advance of conformity assessment procedure completion and as a result it is expected to be at the end stages of the production process. When the conformity assessment procedure requires a notified body to be involved in the production phase, the identification number of the notified body must accompany the CE marking.

[1] Quality management systems — Fundamentals and vocabulary

[2] Quality management systems — Requirements

[3] Directive 2007/47/EC, 05 September 2007

[4] Directive 2007/47/EC, 05 September 2007

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Products requiring CE marking

  • Appliances burning gaseous fuels (Directive 2009/142/EC)
  • Ecodesign requirements for energy-related products (Directive 2009/125/EC)
  • Simple pressure vessels (Directive 2009/105/EC and Directive 2014/29/EU)
  • Toys’ safety (Directive 2009/48/EC)
  • Electrical equipment designed for use within certain voltage limits (Directive 2006/95/EC and Directive 2014/35/EU)
  • Machinery (Directive 2006/42/EC)
  • Electromagnetic compatibility (Directive 2004/108/EC and Directive 2014/30/EU)
  • Measuring instruments (Directive 2004/22/EC and Directive 2014/32/EU)
  • Non-automatic weighing instruments (Directive 2009/23/EC and Directive 2014/31/EU)
  • Cableway installations designed to carry persons (Directive 2000/9/EC)
  • Radio equipment and telecommunications terminal equipment (Directive 1999/5/EC and Directive 2014/53/EU)
  • Active implantable medical devices (Directive 90/385/EEC)
  • Medical devices (Directive 93/42/EEC)
  • In vitro diagnostic medical devices (Directive 98/79/EC)
  • Pressure equipment (Directive 97/23/EC and Directive 2014/68/EU)
  • Transportable Pressure equipment (Directive 2010/35/EU)
  • Aerosol Dispensers (Directive 75/324/EEC as amended)
  • Lifts (Directive 95/16/EC and 2014/33/EU)
  • Recreational craft (Directive 94/25/EC and Directive 2013/53/EU)
  • Equipment and protective systems intended for use in potentially explosive atmospheres (Directive 94/9/EC and Directive 2014/34/EU)
  • Explosives for civil uses (Directive 93/15/EEC and Directive 2014/28/EU)
  • Pyrotechnics (Directive 2013/29/EU)
  • Regulation on the Labeling of Tyres (Regulation (EC) No 1222/2009)
  • Personal protective equipment (Directive 89/686/EEC)
  • Marine equipment (Directive 96/98/EC and Directive 2014/90/EU)
  • Noise emission in the environment by equipment for use outdoors (Directive 2000/14/EC)
  • Emissions from non-road mobile machinery (Directive 97/68/EC as amended)
  • Energy labeling (Directive 2010/30/EU)

Overview of Modules[1]

Modules Description
A Covers both design and production.
Internal Production Control A + tests on specific aspects of the product carried out by an in-house accredited body or under the responsibility of a notified body chosen by the manufacturer.
A1 Covers both design and production.
 Internal production control plus supervised product testing A + product checks at random intervals carried out by a notified body or in- house accredited body.
B Covers design.
EU-type examination It is always followed by other modules by which the conformity of the products to the approved EU-type is demonstrated.
A notified body examines the technical design and or the specimen of a type and verifies and attests that it meets the requirements of the legislative instrument that apply to it by issuing an EU-type examination certificate. There are 3 ways to carry out EU-type examination: 1) production type, 2) combination of production type and design type and 3) design type.
C Covers production and follows module B.
Conformity to EU-type based on internal production control Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved under module B.
C1 Covers production and follows module B.
Conformity to EU-type based on internal production control plus supervised product testing Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved under module B.
C + tests on specific aspects of the product carried out by an in-house accredited body or under the responsibility of a notified body chosen by the manufacturer.
C2 Covers production and follows module B.
Conformity to EU-type based on internal production control plus supervised product checks at random intervals Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved under module B.
C + product checks at random intervals tests on specific aspects of the product carried out by a notified body or in-house accredited body.
D
Conformity to EU-type based on quality assurance of the production process Covers production and follows module B.
The manufacturer operates a production (manufacturing part and inspection of final product) quality assurance system in order to ensure conformity to EU- type. The notified body assesses the quality system.
D1 Covers both design and production.
Quality assurance of the production process The manufacturer operates a production (manufacturing part and inspection of final product) quality assurance system in order to ensure conformity to legislative requirements (no EU-type, used like D without module B). The notified body assesses the production (manufacturing part and inspection of final product) quality system.
E Covers production and follows module B.
Conformity to EU-type based on product quality assurance The manufacturer operates a product quality (= production quality without the manufacturing part) assurance system for final product inspection and testing in order to ensure conformity to EU-type. A notified body assesses the quality system.
The idea behind module E is similar to the one under module D: both are based on a quality system and follow module B. Their difference is that the quality system under module E aims to ensure the quality of the final product, while the quality system under module D (and D1 too) aims to ensure the quality of the whole production process (that includes the manufacturing part and the test of final product). E is thus similar to module D without the provisions relating to the manufacturing process
E1 Covers both design and production.
Quality assurance of final product inspection and testing The manufacturer operates a product quality (= production quality without the manufacturing part) assurance system for final product inspection and testing in order to ensure conformity to the legislative requirements (no module B (EU-type), used like E without module B). The notified body assesses the quality system. The idea
The idea behind module E1 is similar to the one under module D1: both are based on a quality system. Their difference is that the quality system under module E1 aims to ensure the quality of the final product, while the quality system under module D1 aims to ensure the quality of the whole production process (that includes the manufacturing part and the test of final product).  E1 is thus similar to module D1 without the provisions relating to the manufacturing process.
F Covers production and follows module B.
Conformity to EU-type based on product verification The manufacturer ensures compliance of the manufactured products to approved EU-type. The notified body carries out product examinations (testing of every product or statistical checks) in order to control product conformity to EU-type.
Module F is like C2 but the notified body carries out more systematic product checks.
F1 Covers both design and production.
Conformity based on product verification The manufacturer ensures compliance of the manufactured products to the legislative requirements. The notified body carries out product examinations (testing of every product or statistical checks) in order to control product conformity to the legislative requirements (no EU-type, used like F without module B)
Module F1 is like A2 but the notified body carries out more detailed product checks.
G Covers both design and production.
Conformity based on unit verification The manufacturer ensures compliance of the manufactured products to the legislative requirements. The notified body verifies every individual product in order to ensure conformity to legislative requirements (no EU-type).
H Covers both design and production.
Conformity based on full quality assurance The manufacturer operates a full quality assurance system in order to ensure conformity to legislative requirements (no EU-type). The notified body assesses the quality system.
H1 Covers both design and production.
Conformity based on full quality assurance plus design examination The manufacturer operates a full quality assurance system in order to ensure conformity to legislative requirements (no EU-type). The notified body assesses the quality system and the product design and issues an EU design examination certificate.
Module H1 in comparison to module H provides in addition that the notified body carries out a more detailed examination of the product design.
The EU-design examination certificate must not be confused with the EU-type examination certificate of module B that attests the conformity of a specimen ‘representative of the production envisaged’, so that the conformity of the products may be checked against this specimen. Under EU design examination certificate of module H1, there is no such specimen. EU design examination certificate attests that the conformity of the design of the product has been checked and certified by a notified body.

[1] The ‘Blue Guide’ on the implementation of EU products rules 2016. (2016). Official Journal of the European Union, C(272/01).

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什么是“CE 标志”?

在欧洲经济区 (欧经区) (28个欧盟国家,连同冰岛、列支敦士登和挪威) 的单一市场上投放的许多产品均附有一个标志, 均附有一个”CE” 字母的标志。CE标志是一种合格标志,它代表 “Conformité Européene”,其字面意思是 “欧洲合格”。

法规 (EC) No 765/2008200879

CE 标志一般原则受到《法规 (EC) No 765/2008》的管辖,该法规规定了产品市场的合格鉴定以及市场监督的相关要求。

法规 (EC) No 765/2008的第2.20条款,2008年7月9日

CE 标志的含义是:“加贴CE标志,则代表制造商指明该产品符合欧盟共同体协调法规中规定的适用的加盖要求”

这意味着,在产品上加贴CE标志,则表示该产品相关制造商做出声明,表明他承担独立责任,保证遵守适用的健康、安全和环境保护法规,并符合所有相关的产品立法要求,在此前提下才将产品投放市场。

此外,制造商还应确保其在欧洲经济区市场上投放的产品的有效性。

CE 标志的好处是什么?

CE 标志被看作是进入欧洲经济区30个国家市场并在这些国家的市场中自由流通的产品“通行证”。

这一进入欧洲市场的便利途径,是通过整个欧洲的产品要求立法协调带来的。

这意味着,一旦制造商确保其法律合规性并加盖 CE 标志,则产品将有机会进入欧洲经济区的所有不同成员国,而无需调整适应欧洲经济区中不同成员国各自的特定要求的彼此冲突的要求

同时,对这些要求的执行提高了产品的安全性和可靠性,从而降低了客户不满意率,并降低了相关责任索赔的风险。

哪些产品需要加盖CE 标志?

对于所有需要进入欧洲经济区市场并且涉及至少一个或多个欧盟协调指令的产品 (例子请参见下文附录 1),CE 标志是强制性的 。相反,不属于欧盟协调法案适用领域的产品,则不允许使用 CE 标志。

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Tuning Fork 公司可向基于中国的生产商提供以下服务:

1.      欧盟文件及标准派递服务。

1.1   欧盟产品指令

1.2 欧洲标准

1.3   其他欧盟官方文件

2.     技术咨询服务

2.1 关于合规性工程的技术建议

2.2 安全和风险评估

3. 合规性测试服务

3.1 合规性测试前期安排

3.2 完整合规性测试安排

4.     技术文件服务

4.1 技术文件 (技术文档):指导该文件的准备工作。

4.2欧盟符合性声明:用几种语言指导并准备这份文件。

5. 标签和文件翻译:

安排从英语到每个欧盟成员国官方语言的翻译

5.1 用户手册和安装说明

5.2 标签建议和翻译

6. 欧洲 (欧经区/欧盟) 授权/批准的代表处服务

6.1 Tuning Fork 名称&地址及办事处的使用:

6.2 产品注册:以欧洲授权/批准的代表身份,在欧经区向主管当局 (CA) 注册境内医疗器械 (MDD) /体外诊断试剂 (IVD) 产品

6.3 续订及产品注册更新:在产品更改时更新其注册信息

6.4 保留技术文件:

6.5 立法监测:监测并报告与产品有关的欧洲产品立法的新发展

6.6 警惕和异常事件报告:协助处理产品警戒和异常事件报告

6.7 产品召回和忠告性通知:协助处理产品召回,并发出忠告性通知

CE 标志的程序有哪些?

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CE 标志的程序有哪些?

阶段1:

确定适用的欧盟指令和协调标准

应确定面向欧洲经济区市场的产品所适用的欧盟指令,以便确定该产品是否需要 CE 标志。

然后要对产品进行符合性评估,使其符合适用指令中的基本要求,涵盖该产品的设计和生产阶段。

然后,制造商确定并执行产品在获取CE 标志时适用的协调欧洲标准。

阶段2:

确定符合性评估程序

符合性评估中包含一个由制造商负责执行的过程,以证明欧盟指令中的适用要求已经实现

这一进程已在《决定 No 768/2008 EC 》中做出了规定。

一共有8个符合性评估程序,称作模块 (以A至H字母命名),其中一些有变体。

制造商应选择一个或两个符合性评估模块,以确保指令合规性同时涵盖设计和生产这两个阶段。

附录2概述了不同的符合性评估模块及其说明。

阶段3:

对产品进行一个符合性评估

每个模块都规定了制造商应承担的不同责任,并根据适用的指令和产品的风险分类,确定了符合性的不同途径。

从本质上讲,符合性评估途径包括:

有制造商对产品进行评估,没有第三方参与。

此选项适用于设计及生产机制复杂性较低的情况,这些产品因此对公共利益的风险较低 (如模块 A) 。

质量管理体系 — 基本原理和词汇

质量管理体系 — 要求

有制造商对产品进行评估,并有额外的强制性审计要求,需由制造商指定一家公告机构执行。

一些此类模块基于EN ISO 9000 和 EN ISO 9001 标准的质量保证技术 (例如,D、E 和 H 模块) 。

这适用于设计复杂性更高以及在使用中公共风险会增加的产品。

由一家公告机构执行产品评估,涉及服务包括产品测试和型式检验认证问题等等,同时由制造商挑选一家公告机构执行强制审计(例如模块H)。

这适用于设计非常复杂、对用户安全风险很大的产品。

阶段4:

技术文件的汇编和维护

接下来,您的产品若要获得正面的符合性评估结果,还需要编制一份技术文件。

这包括一系列技术文件 (例如技术说明、材料清单、规格、测试报告、使用说明和欧盟符合性声明(EU DoC)),以证实产品的设计、开发和生产均符合欧盟指令均符合欧盟指令。

该技术文件 (包括欧盟符合性声明) 必须在最后一件产品投放市场之后继续保留10年。

指令 2007/47/EC,2007年9月05日

某些指令 (如经指令2007/47/EC 修正的关于医疗设备的理事会指令 93/42/EEC),有一项要求,要求制造商在欧盟中任命一名授权代表,该代表负责根据市场监督机构的要求提供技术文件。

此外,某些指令规定,如果制造商在欧洲经济区内没有注册营业地,则应在标签、外包装和产品说明书上注明欧盟授权代表的地址名称。

阶段5:

欧盟符合性声明的准备和维护

制造商,或在欧盟成立的授权代表,必须完成并签署一份欧盟符合性声明,表明对产品对适用的欧盟指令的符合性承担责任。

在内容方面,这一声明包含该产品符合的指令和协调的欧洲标准的列表、产品标识、制造商和授权代表的名称、地址和批准。

阶段6:

欧盟产品注册

某些类别的产品,如医疗器械,要求在欧洲经济共同体中正式注册,并出具注册证书

阶段7:

在产品和/或包装上加盖 CE 标志

CE 标志必须以易读并且不可擦除的样式,加盖于产品之上,如果考虑到产品性质无法加盖在产品之上,则必须加盖于产品包装之上

此外,CE 标记必须附在产品附带的任何文档中。

CE 标志不得在符合性评估程序完成前贴在产品上,因此应在生产过程的最后阶段进行加盖。

当符合性评估程序要求公告机构参与生产阶段时,该公告机构的标识号码必须伴随CE 标志。

CE 标志过程图解1

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需要 CE 标志的产品

使用气体燃料的电气用具 (指令 2009/142/EC)

能源相关产品的生态设计要求 (指令 2009/125/EC)

简单压力容器 (指令 2009/105/EC 和指令 2014/29/EU)

玩具安全 (指令 2009/48/EC)

设计在一定电压范围内使用的电气设备 (指令 2006/95/EC 和指令 2014/35/EU)

机械 (指令 2006/42/EC)

电磁兼容性 (指令 2004/108/EC 和指令 2014/30/EU)

测量仪器 (指令 2004/22/EC和指令 2014/32/EU)

非自动称量仪器 (指令 2009/23/EC 和指令 2014/31/EU)

设计用于载人的索道装置 (指令 2000/9/EC)

无线电设备和电信终端设备 (指令 1999/5/EC 和指令 2014/53/EU)

无线电设备和电信终端设备 (指令 1999/5/EC 和指令 2014/53/EU)

医疗器械 (指令 93/42/EEC)

体外诊断医疗器械 (指令 98/79/EC)

压力设备 (指令 97/23/EC 和指令 2014/68/EU)

可移动压力设备 (指令 2010/35/EU)

气溶胶发生器 (经修订的指令 75/324/EEC)

升降机 (Directive 95/16/EC 和 2014/33/EU)

游艇 (指令 94/25/EC和指令 2013/53/EU)

拟在潜在爆炸性环境中使用的设备和保护系统 (指令 94/9/EC 和指令 2014/34/欧盟)

民用炸药 (指令 93/15/EEC 和指令 2014/28/EU)

烟火 (指令 2013/29/EU)

轮胎标签法规 (法规 (EC) 1222/2009)

个人防护设备 (指令 89/686/EEC)

船用设备 (指令 96/98/EC 和指令 2014/90/EU)

室外使用设备在环境中的噪声排放 (Directive 2000/14/EC)

非道路流动机械的排放量 (经修正的指令 97/68/EC)

能源标签 (指令 2010/30/EU)

《2016年欧盟产品规定实施指南》(亦称《蓝色指南》)(2016)。

《欧盟官方公报》,C (272/01)

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模块概述
模块
描述
A

内部生产控制

涵盖设计和生产。

由内部认可认证机构,或由制造商指定的公告机构,对产品特定方面进行的A + 测试。

A1

内部生产控制,加上监督之下的产品测试

涵盖设计和生产。

由一家公告机构或内部认可的认证机构,以任意时间间隔内对产品进行的A + 产品检查。

B

欧盟型式检验

涵盖设计。
在其之后总是有其他模块,这些模块会对批准的欧盟型式的产品符合性进行证明。
一家公告机构对一个产品型式的技术设计和/或样本进行检验,验证它是否符合适用的法律文书的要求,并签发一个欧盟型式检验证书以兹证明。执行欧盟型式检验共有三种方式: 1) 生产型式,2) 生产型式和设计型式相结合,以及3)设计型式。
C

根据内部生产控制,符合欧盟型式

涵盖生产并遵循模块 B。

制造商必须内部控制其生产,以确保其产品符合模块B中批准的欧盟型式。

C1

根据内部生产控制以及监管之下的产品测试,符合欧盟型式

涵盖生产并遵循模块 B。
制造商必须内部控制其生产,以确保其产品符合模块B中批准的欧盟型式。
由内部认可认证机构,或由制造商指定的公告机构,对产品特定方面进行的C + 测试。
C2

根据内部生产控制以及随机时间间隔的监管之下的产品测试的,符合欧盟型式

涵盖生产并遵循模块 B。
制造商必须内部控制其生产,以确保其产品符合模块B中批准的欧盟型式。
由一家公告机构或内部认可的认证机构,以任意时间间隔内对产品的特定方面进行的A + 产品检查。
D
根据生产过程质量保证,符合欧盟型式
涵盖生产并遵循模块 B。

制造商运行一个生产(制造部分和最终产品的检验)质量保证体系,以确保符合欧盟型式。

公告机构评估质量体系。

D1

生产过程的质量保证

涵盖设计和生产。
制造商运行一个生产(制造部分和最终产品的检验)质量保证体系,以确保符合法规要求 (非欧盟型式,用于例如模块D,不包括模块B)。
公告机构评估生产(制造部分和最终产品检验)质量体系。
E

根据产品质量保证,符合欧盟型式

涵盖生产并遵循模块 B。
制造商运行一个产品质量(= 生产质量,不包括制造部分)保证体系,进行最终产品检验和测试,以确保符合欧盟型式。
一家公告机构评估质量体系。
模块 E 背后的想法与模块 D 类似:两者都是基于质量体系,并且都遵循模块 B。它们的区别在于,模块 E 的质量体系旨在确保最终产品的质量,而模块 D (和 D1) 下的质量体系旨在确保整个生产过程的质量 (包括制造部分和最终产品测

试)。因此模块E与模块D类似,但没有关于制造过程的规定。

E1

最终产品检验和测试的质量保证

涵盖设计和生产。
制造商运行一个产品质量(= 生产质量,不包括制造部分)保证体系,进行最终产品检验和测试,以确保符合法规要求 (非模块B(欧盟型式),用于例如模块D,不包括模块B)。
公告机构评估质量体系。
模块 E1 背后的想法与模块 D1类似:两者都基于质量体系。
它们的区别在于,模块 E1 下的质量体系旨在保证最终产品的质量,而模块 D1 下的质量体系旨在保证整个生产过程的质量 (包括制造部分和最终产品测试)。
因此模块E1与模块D1类似,但没有关于制造过程的规定。
F

根据产品验证,符合欧盟型式

涵盖生产并遵循模块 B。
制造商确保生产的产品符合批准的欧盟型式。
公告机构执行产品检验(每种产品的检验或统计检查),以控制产品符合欧盟型式。
模块F 类似模块C2,但是公告机构会进行更加系统的产品检查。
F1

基于产品验证的符合性

涵盖设计和生产。
制造商确保生产的产品符合法规要求。
公告机构执行产品检验 (每种产品的检验或统计检查),以控制产品对法规要求的符合性 (非欧盟型式,用于例如模块F,不包括模块B)。
模块F1 类似模块A2,但是公告机构会进行更加细致的产品检查。
G

基于单元验证的符合性

涵盖设计和生产。
制造商确保生产的产品符合法规要求。
公告机构验证每个独立产品,以确保产品对法规要求的符合性(非欧盟型式)。
H

基于完整质量保证的符合性

涵盖设计和生产。
制造商运行一个完整的质量保证体系,以确保符合法规要求(非欧盟型式)。
公告机构评估质量体系。
H1

基于完整质量保证加上设计检验的符合性。

涵盖设计和生产。
制造商运行一个完整的质量保证体系,以确保符合法规要求(非欧盟型式)。
公告机构评估该质量体系,以及产品设计,并出具一份欧盟设计检验证书。
模块 H1 与模块 H 相比,额外规定了公告机构要执行一个更加细致的产品设计检验。
欧盟设计检验证书不得与模块B的欧盟型式检验证书混淆,后者证明了一个“具有生产代表性的”样品的符合性,所以产品符合性可以根据这一样品进行检查。
在模块H1的欧盟设计检验证书中,并没有这类样品。
欧盟设计检验证书证明,产品设计的符合性已由一个公告机构进行检查并认证。

《2016年欧盟产品规定实施指南》(亦称《蓝色指南》)(2016)。

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