MED3./30 Portable oxygen analysis and gas detection equipment

FAQ

Short text about what the Q&A contains and where they can turn if they don't get the answers they need here.

  • What marking is required for a Marine Equipment confirming to the Marine Equipment Directive?

    While most EC directives require products to carrying the "CE" mark, products certified under the Marine Equipment Directive carry the "wheel mark".

  • What does the Directive cover?

    The directive covers types of marine equipment that fall under following International Conventions developed by the International Maritime Organization (IMO):

    • SOLAS 1974: Life-saving appliances/navigation equipment/radio equipment
    • MARPOL 1973: Marine pollution
    • COLREGS 1972: Prevention of collisions

    Design, construction and performance requirements and testing standards for marine equipment is provided in the latest Annex to Commission Implementing Regulation, which was published in the Official Journal of the European Union.

  • Is a risk analysis needed?

    Yes.

    The adequate analysis and assessment of the risk(s) is the responsibility of the

    manufacturer.

    In case the manufacturer evaluates that applicable standards cover all reasonably

    foreseeable risks, the manufacturer should simply declare this in the technical

    documentation.

    This ensures that the risk assessment requirement (in Annex II, Part I Module B: EC Type-

    Examination, point 3, third indent) is fulfilled.

    In case the manufacturer evaluates that the applicable standards do not cover all reasonably

    foreseeable risks, the manufacturer should identify and analyse the risks and describe the

    measures taken to address them.

    The Notified Body involved verifies that the technical documentation addresses a risk

    assessment.

  • What should a DoC contain?

    1. No … (unique identification of the product):

    2. Name and address of the manufacturer or his authorised representative:

    3. This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):

    4. Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate):………………

    5. The object of the declaration described above is in conformity with the relevant Community harmonisation legislation: ………………

    6. References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared:………………

    7. Where applicable:

    • The notified body (name, number):………
    • performed (description of intervention):………
    • and issued the certificate: ………

    8. Additional information:

    • Signed for and on behalf of: (place and date of issue): ………
    • signature(name, function): ………
  • When shall wheel mark be affixed on the product?

    The product shall be wheel marked at the end of the production phase. The wheel mark shall be followed by the number of the notified body which was issuing Module D/E or F/G and the year of production.

  • How shall the wheel mark look like?

    The wheel mark shall be affixed visibly, legibly and indelibly to the marine equipment/ product or to its data plate and where relevant, embedded in its software. Where that is not possible or not warranted because of the nature of the product, it shall be affixed to the packaging and to the accompanying documents.

    Illustration

    Furthermore, manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing their identification. In addition, they shall indicate their name, registered trade name or registered trademark and the address at which they can be contacted on the product.

TERMS OF USE OF THE DBI CERTIFICATION A/S WEBSITE

Copyright © All material on DBI Certification's website is protected by copyright law. If you have questions about how you may use our material, you are welcome to contact us at info@dbicertification.dk