Below are some of the most frequently asked questions concerning the CE Mark:

Q - We want to CE Mark our packaging equipment. Which European Directives and Standards apply to our equipment?

A - On a typical packaging machine at least 3 Directives apply: The Electromagnetic Compatibility Directive, The Machinery Directive and Low Voltage Directive. Depending on the intended use of the equipment (residential laboratory, industrial, etc.) different standards can apply within the same Directive. Additional Directives may apply to the CE Marking depending on the equipment specifications.

Q - When is ISO9000 Certification important if we want to CE Mark our products?

A - ISO 9000 can become a major part of CE Mark certification. Under the Personal Protective Equipment Directive for instance, in addition to laboratory tests, manufacturers can choose either to be subject to Notified Body visits and product sampling, or to be ISO 9000 certified by an approved and recognized Registrar. Cost savings can also be realized by becoming ISO 9000 Certified. LTC works closely with various registrars for companies interested in Quality System Certification.

Q - Our machine is listed under Annex IV of the Machinery Directive, what do we need to do concerning the CE Mark requirements?

A - Annex IV of the Machinery Directive lists categories of ¡°high risk¡± machines which require the involvement of a Notified Body to approve the machinery prior to export. The Notified Body is typically involved in all steps of the CE Marking process, up to final approval. If applicable other Directives must also be complied with in order to receive Notified Body approval.

Q - What happens if we sell apply the CE Mark label to our machines without complying to the Directives?

A - Enforcement is carried out on a member state basis. Heavy fines can be imposed on the manufacturer and current and future products banned from the market. The CE Mark is a requirement if exporting to Europe, not a voluntary process.

Q - What if our semiconductor tool must comply with both SEMI Guidelines and the CE Marking requirements?

A - A combined certification with the same company is suggested in order to reduce your time and expenses. Your customer may request partial compliance to the SEMI Guidelines, yet full CE Mark compliance to EU Directives is mandated. It is critical that as much technical information on the system be submitted to correctly determine the scope of the compliance project.

Q - A dozen safety standards apply to our machinery we want to CE Mark, how can we reduce the complexity, time and expenses related to their purchase, review and implementation?

A - To make matters worst, safety standards and requirements are often subject to revision and only a portion of an applicable standard may apply to your product. The best answer is to talk with an experienced organization such as LTC that will guide and simplify the process.