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  2. CE marking - Wikipedia

    en.wikipedia.org/wiki/CE_marking

    Stage 6: Make a declaration and affix the CE marking. When the manufacturer, importer or authorised representative is satisfied that their product conforms to the applicable norms, an EU declaration of conformity must be completed or, for partly completed machinery under the Machinery Directive, an ECU declaration of incorporation. [13]

  3. European Authorized Representative - Wikipedia

    en.wikipedia.org/wiki/European_Authorized...

    An authorised representative may also carry out a conformity assessment of a medical device on behalf of the manufacturer. [ 7 ] European ‘Blue Guide" [ 8 ] describes that delegation of an authorised representative should be set out in writing (as an agreement, mandate, or power of attorney) to define contents and limits of tasks.

  4. Type approval - Wikipedia

    en.wikipedia.org/wiki/Type_approval

    The CE mark found on the back of many electronic devices does not mean that the product has obtained type approval in the European Union. The CE mark is the manufacturer's declaration that the system/assembly meets the minimum safety requirements of all the directives (laws) applicable to it, and of itself, does not signify any third party ...

  5. Certification mark - Wikipedia

    en.wikipedia.org/wiki/Certification_mark

    Canadian certification label on a bag of rockwool Counterfeit electrical cords with false UL certification marks. A certification mark on a commercial product or service is a registered mark that enables its owner ("certification body") to certify that the goods or services of a particular provider (who is not the owner of the certification mark) have particular properties, e.g., regional or ...

  6. Notified body - Wikipedia

    en.wikipedia.org/wiki/Notified_Body

    CE Mark. A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations.

  7. RoHS - Wikipedia

    en.wikipedia.org/wiki/RoHS

    The CE logo RoHS and CE mark on a car charger. Products within scope of the RoHS 2 directive must display the CE mark, the manufacturers name and address and a serial or batch number. Parties needing to know more detailed compliance information can find this on the EU Declaration of Conformity for the product as created by the manufacturer ...

  8. FCC mark - Wikipedia

    en.wikipedia.org/wiki/FCC_mark

    The FCC logo or the FCC mark is a voluntary mark employed on electronic products manufactured or sold in the United States which indicates that the electromagnetic radiation from the device is below the limits specified by the Federal Communications Commission and the manufacturer has followed the requirements of the Supplier's Declaration of Conformity authorization procedures.

  9. Medical Devices Directive - Wikipedia

    en.wikipedia.org/wiki/Medical_Devices_Directive

    Manufacturers' products meeting 'harmonised standards' [1] have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made.