Marks approval

UN type approval mark Confirm nature of hazards from labels Visual check on condition of CTU... 

Food Drug Letter. 2002. Claritin approval marks significant shift in Rx-to-OTC Switches. Food Drug Lett. (FDANews.com, Issue No. 666). 

Chlorine, sulfur and zinc are potentially harmful chemical elements. Paints and crayons used to mark susceptible alloys must contain low quantities (measured in parts per million, or ppm) of the harmful chemical elements. Less than 100 ppm is allowable. Even if approved marking materials are used, they should be removed from areas that are to be welded, brazed or soldered. An approved solvent such as a non-chlorinat-ed type should be used to remove marking materials. The same principles apply when adhesive-backed tapes are used to fix items to stainless and nickel alloy products (e.g., for radiography). All traces of adhesive must be removed from the surface with an approved solvent. There are no restrictions on using fiber tip markers because they do not leave solid residue. Solvent removal is not required with fiber tip markers. 

In addition to the CE marking affixed to a product, customers may demand a European third-party (notified body) approval mark, certification, or test report connoting a higher level of quality to ensure safety/EMC compliance. To control non-conforming products the following clause from the Official Journal of the European Communities (OJEC) applies ... 

Certification and approvals are statements by an impartial accredited body that a product or service fulfills specific requirements, such as directives and standards. Certification may be mandatory, as is the case for some regulated products (Annex IV machines, telecom, medical devices, etc.), or voluntary as Is the case for most product and machine categories. Manufacturers often seek voluntary certification to assure themselves, customers, and authorities that their products meet the requirements set by law. Certification is commonplace in Europe and allows the use of a distinctive approval mark affixed to the product that is backed by a certificate and test report. The approval mark, is a recognized quality mark attesting to a products conformity to the relevant requirements, such as for EMC and safety. 

Test sample products for conformity and award Approval Marks, with ongoing surveillance of production, to visibly demonstrate product quality and increase marketing advantage. 

An approval mark and certificate visibly demonstrate product quality (safety/ EMC) and can lay to rest any doubts the consumer may have concerning a product s conformity to the EU directives and standards. The requirement for certification can come from ... 

Consumers and users who often look for and expect a recognizable approval mark. 

Due diligence is a matter of record Over 100,000 products have received the GS Mark (GS = Safety Tested). Numerous Type-Approval Marks for components and EMC Marks have also been issued. 

The increased marketing potential of certification and approval marks should not be overlooked. As the Official Journal states ... 

Approval Mark + Test Report = Sales Success + Due Diligence... 

The approval mark on the product and accompanying test report from a notified body serve two purposes. In regards to safety/EMC conformity, the test report is the manufacturer s best line of defense if the product s safety is questioned, and a reputable approval mark on the product is marketing s best sales tool As the European Commissions Guidelines on the Application of Council Directive 73/23/EEC (LVD), states ... 

When customers see an approval mark they know and trust (i.e., VDE/TUV/ BG) they can be assured that the testing was performed to exacting quality standards and that an accurate test report and certificate exist. Figure 4-2 shows the hierarchy of European conformity acceptance. With today s liberalized approach (CE = self test), where testing and approvals for most products are no longer compulsory, the quality of the approval mark is more important than ever. There is a greater potential for abuse under the new system that must be counteracted by effective surveillance checks by the authorities, users, and competitors. Product manufacturers and suppliers should utilize testing and approval bodies with the... 

The highest level for conformity verification and acceptance in Europe are the voluntary product safety and EMC Approval Marks, issued by European notified and competent bodies. The Approval Mark is backed by an official test report and certificate from a European accredited body (OJEC). 

Approval Mark on product is visible to customers for increased marketing and sales potential. 

No Approval Mark or Certificate for potential customers and national enforcement authorities. 

The CB Scheme is a mutual recognition of test results scheme for safety of electrical products. The CB Scheme is intended to Tacilitate certification or approval at a national level (see Approval Marks above). 

EU notified bodies may accept CB Certificate for issuance of notified body Approval Mark (above). 

No visible Approval Mark on product with only CB Cert. 

Figures 4-3, 4-4, and 4-5 illustrate examples of approval mark certificates issued by European bodies.

An approval mark on the equipment is always advisable, for if there is no mark on the equipment, the buyer may check for conformity, thus, increasing risk. To... 

The manufacturer s best line of defense is a test report and approval mark from a notified body. 

The European bodies (especially in Germany) issue certified approvals and marks according to clearly defined standards, which are definitive statements on their assessment results. The European approval term means that the equipment bearing an approval mark has been successfully tested and passed, but more important, approvals are perceived by users and customers as a guarantee that the equipment is safe for use (see Notified Bodies and Certification in Chapter 4). 

Check for components with European Approval Marks as positive evidence of compliance ( CE not considered). 

Utilizing nonapproved components in the equipment places the end-product manufacturer in a precarious position especially with regard to testing, documentation, and ongoing conformity of the components. The CE marking is only a selfdeclaration, and if the component has no European type-approval mark, the end-product manufacturer may have to do additional testing ... 

To ensure safety compliance and limit testing, end-product manufacturers often demand prequalified safety-sensitive components with EU type-approval marks (VDE/TUV). These component marks help to ensure compliance with standards and reduce testing. Components with VDE/TUV marks need only be checked for proper application and use in the product. European-approved components may cost a little more, but they are usually more reliable, and in the long run will save the product designer much aggravation and time. Figure 6-1 shows some of the standards that require components safety compliance. 

If a critical or safety component does not have the proper approval mark, the test and certification body may fail the product or require testing of the component. Manufacturers doing a self-assessment of their equipment should use the same criteria as the EU bodies and select only components that they know have been tested, certified, and bear an EU approval mark. Anything less may require additional testing and/or review by a European component expert. See Figure 6-2 for component acceptance criteria. 

Because of the almost universal acceptance of the European standards (EN and lEC) around the world many suppliers now offer components that are EU type-approved, in addition to the U.S. recognition. The U.S. is also moving toward acceptance of the European product standards. Unfortunately, at this time U.S. and EU product and component standards are different. The United States focuses on fire hazards and materials, whereas Europe stresses shock hazards and construction. Because of these and other substantial safety differences, component suppliers realize the need for dual approvals to satisfy both the U.S. and International requirements. As a minimum, one mark for North America (UL) and one for Europe (VDE) should be considered. Many component suppliers now offer components with this dual certification. A certificate and test report from the testing and certification body supports the type approval mark. The mark is affixed to the component and is visually recognized by interested parties as positive evidence of compliance. 

Learn to recognize EU approval marks. Look at a component and... 

A EU Type-Approval Mark 1 Component was tested by European accredited testing and certification body and bears the Type-Approval Mark as positive evidence on conformity. Test report is on file with EU body and available on request. 2 End-product manufacturer confirms approval by observing Type-Approval Mark on component and obtains copy of the approval certificate, if necessary, for their technical file. Pass... 

B Accredited Lab tested 1 Occasionally components are tested by a EU Accredited Lab (DAR for Germany) and do not bear a type-approval mark. The lab accreditation certificate, test report, and test verification must be readily available. 2 The lab accreditation certificate and test verification is obtained by end-product manufacturer and placed into the technical file. It is also advisable to obtain a copy of the test report for review. Conditional acceptance (case by case)... 

C Manufacturer Self -Test ( CE marking) 1 Component supplier claims to meet EU safety standards (i.e., EN, lEC, VDE) and offers CE marking in lieu of type-approval mark. 2 Since self-declarations and CE are not positive evidence, the end-product manufacturer should, in order of preference (a) reject component and select alternative, or (b) test component, if pass document, or (c) if EU type-approval exists on similar components within same series, expert reviews test report and sample component for acceptance/rejection. Questionable (reject or test)... 

D Evidence not available 1 No positive evidence available (e.g., no EU approval mark or third party report). 2 Product manufacturer rejects component, or performs complete testing, according to the relevant standard(s). Testing by EU third-party expert prefeired. Fail... 

CE markings and declarations are not considered as evidence of conformity. Components bearing the appropriate European type-approval mark (VDE/TUV) need only to be checked for proper application in the end product. Components without an approval should be assessed and tested according to the relevant EN/IEC component standard and for application in the end product. 

Safety components such as light curtains, sensor mats, and two-hand controls are regulated by Machinery Directive 89/392/EEC which requires a manufacturer s declaration of conformity but no CE marking. EU type-approval marks are also highly recommended for safety components. 

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