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CE Marking is The Bridge to Europe

Compliance to the applicable European directives and application of the CE marking are mandatory for shipment into the European Union (EU). Earth Tech can support equipment manufacturers' efforts in declaring compliance to the Machinery and Low Voltage Directives. All service realms available for support of SEMI S2 compliance are also available for these important areas of European compliance.

Who is the European Union (EU)?

The EU includes the following 25 Member States (countries):

Original 15 Member States:

Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

New Member States as of May 1, 2004 :

Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia, Slovenia

What are the applicable EU requirements?

European regulatory requirements (laws) are called ‘directives’ and are developed and implemented by the European Commission. Each directive defines its scope and provides essential requirements and methods to demonstrate compliance with it. Usually, more than one directive will apply to a particular type of equipment. Manufacturers must demonstrate the compliance of their equipment with each of the directives that apply to it.

Industrial equipment (e.g., those used for semiconductor and disk-drive manufacturing) is within the scope of the three directives listed below. Other directives may also apply (e.g., Pressure Equipment Directive) and must be considered for each piece of equipment.

Low Voltage Directive (73/23/EEC):

This directive applies to any equipment “designed for use with a voltage rating of between 50 and 1,000 VAC and between 75 and 1,500 VDC.” Its focus is on the electrical safety of the equipment.

Machinery Directive (98/37/EC):

This directive applies to machinery, defined as an assembly of linked parts at least one of which moves, joined together for a specific application. It also applies to safety components that are defined as any component that is used to fulfill a safety function and the failure of which endangers the safety or health of exposed persons. Compliance with this directive is much more involved than the others mentioned above since it addresses all hazards associated with the equipment (e.g., electrical, mechanical, chemical, temperature, ergonomic, etc.).

EMC Directive (89/336/EEC):

This directive applies to equipment that is likely to cause electromagnetic disturbance (emissions) or the performance of which is likely to be affected by such disturbance (immunity). It addresses the electromagnetic interference (EMI) emitted by the equipment, as well as how susceptible the equipment is to EMI emitted from other electrical or electronic equipment.

How do manufacturers demonstrate compliance?

Manufacturers must have their equipment evaluated using applicable European Harmonized standards (also called European Norms or ENs) for each directive. If the equipment meets the requirements in the standards, the manufacturer uses the resulting test reports as part of its technical documentation, affixes a ‘CE’ marking (see below) to the equipment and drafts a Declaration of Conformity (DoC). A copy of the DoC needs to be included in the shipping documentation for each piece of equipment shipped to the EU.

Self-Declaration & Certification :

For the Low Voltage and Machinery Directives, the manufacturer will ‘self-declare’ compliance with the directives. This means that it is not required to obtain a certificate or license to declare compliance, even though it will still have a third-party test lab conduct the testing and issue the reports. However, for the EMC Directive, depending on how the equipment is tested (i.e. in a formal lab or on-site testing), the manufacturer may have to obtain a Competent Body Certificate to declare compliance. If the equipment can be sent to an EMC lab for testing, the manufacturer can self-declare compliance due to the nature of the emissions testing (i.e. within an anechoic chamber). For large equipment, it may not be practical to send it to a lab and, instead, EMC testing is done at the manufacturer’s facility. The directive allows this but it is considered to be not applying the standard in full and, therefore, the EMC lab that does the testing must be one that has a relationship with (or is) a European Competent Body. Once the equipment passes all the testing, the test lab issues the resulting report as well as a certificate from the Competent Body. This certificate would be referenced on the manufacturer’s Declaration of Conformity.

Standards

For compliance with the Low Voltage Directive, the European electrical safety standard that is typically applied to industrial equipment is EN 60204-1 (Safety of Machinery – Electrical Equipment of Machines, General Requirements). An evaluation using this standard includes a constructional review of the equipment as well as electrical safety testing. The resulting test report serves as the basis for the manufacturer to self-declare compliance to the Low Voltage Directive.

Compliance with the Machinery Directive is unique since it contains all of its essential requirements in Annex I of the directive. There are many supportive European, national and industry standards that may be referenced and used when applying the essential requirements. The most fundamental European standards include EN 1050 (Principles of Risk Assessment) and EN 292 (Safety of Machinery, Basic Concepts and General Principles for Design). Additionally, the semiconductor industry applies SEMI S2 (Environmental, Health, and Safety Guideline for Semiconductor Manufacturing Equipment). Typically, a line-by-line report of Annex I of the directive, together with all supportive records (e.g. hazard analyses, risk assessments, additional test reports, critical component information, schematics, drawings, specifications), forms the basis for the manufacturer to self-declare compliance with the directive. All this information is what is referred to as a Technical Construction File (TCF) in Annex V of the directive.

How can Earth Tech assist manufacturers with EU requirements?

The Earth Tech team of industry experts from a wide variety of backgrounds (including electrical, chemical, industrial hygiene, ergonomics, occupational safety and risk management) can assist manufacturers to understand, interpret and apply European requirements to their equipment. Earth Tech provides:

• Training

• Testing Services

• Issuance of the Technical Reports

• Assistance with European Documentation (e.g., Declaration of Conformity, Technical Construction File)

Contact us to answer any of your CE Marking questions.