Article Published: April 23, 2014
Article Published: April 23, 2014
By Sam Mastovich, Keystone Compliance
The CE Mark is one of the most popular international accreditation marks pursued by American manufacturers. After testing the waters in Canada and/or Mexico, many domestic manufacturers look to enter the European market next. No other area of the world provides entry into 28 countries with compliance to one accreditation mark.
As a regulatory compliance lab, we work with manufacturers on a weekly basis to assist them with obtaining the CE Mark for their products. This experience has provided insight into four suggestions that manufacturers should consider in order to streamline the CE Mark certification process.
Designing products to meet customer preferences and regulatory compliance requirements can be difficult and often takes a backseat to aesthetics. If not addressed early on, adding electromagnetic filtering, grounding, screening, shielding and gasketing, or modifying the circuit board layout can come at the expense of aesthetics, cost and functionality. These tradeoffs can create internal turmoil between engineers and salespeople. Ultimately, the product must meet the requirements, but do so in such a way that meets customer demand. Finding that happy medium is recommended during the design phase so that significant changes are not required during production.
In addition to IEC standards that must be met, certain products must also meet product-specific directives. These directives contain additional requirements. Examples of directives include but are not limited to appliances, construction products, measuring instruments, pressure vessels, toys, medical devices, machinery, telecommunications equipment and equipment located in explosive atmospheres. Identifying the appropriate directives and related requirements early on will allow greater flexibility to design for compliance. Oftentimes, the requirements of the directives are more stringent than the IEC standards.
A test plan provides the game plan for all of the testing required. Considerations should include; what markets are to be entered, are there slight deviations in products that could allow for a product family to be approved, and what should the order of testing be? It is important to share an overview of the test plan with customers and/or distributors. While uncommon, it is not unheard of for a customer to have requirements that exceed the regulatory requirements. It is important to know this up front so that all requirements can be met in one test program.
When manufacturing a product for CE Mark compliance, it is recommended to always use components that have been CE Mark certified. However, combining one CE Mark certified component with another CE Mark certified component does not automatically create a third CE Mark certified product. Assuming that a product comprised of CE Mark certified components will automatically meet the CE Mark requirements can be a costly mistake.
When properly prepared for, the CE Mark certification is just a formal verification that a product meets the appropriate requirements to be safe for everyone who comes in contact with it. Following the steps mentioned in this article will help streamline the CE Mark certification process, saving considerable time and money.
Keystone Compliance is a New Castle-based, A2LA-accredited regulatory compliance test lab offering EMC/EMI, climatics, dynamics and product safety testing. The company assists manufacturers with meeting military and commercial testing requirements including the CE Mark. Sam Mastovich can be reached at firstname.lastname@example.org or 724-657-9940.