CE Machinery | Machinery

A manufacturer that intends to distribute or sell a product within Europe shall affix a CE mark to the product through declaration or certification of conformity that the product conforms to the applicable EU guidelines. In Europe, the guidelines applicable to the safety of machinery are Machinery Directive 2006/42/EC and apply to all machinery, including transport machines, mechanism, lifts and transport equipment and safety components.

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  CE Machinery(Machinery Safety) European Product Certification Overview

  The definition of machinery is defined in MD as "at least one part of the operation, with multiple interrelated parts and proper actuator, controller and power circuitry." The European Machinery Directive (Machinery Directive:2006/42/EC) is designed to ensure the health and safety of workers in the use of a wide range of machinery and other products, including accessories, chains, ropes and webbing, replacement equipment, mobile mechanical transmitters and safety components.
  
  The following products can be attach CE marks :

  • 1. General industrial machinery : semiconductor equipment, excavator accessories and partial machinery, press, CNC lathe, machine tool, industrial compressor, industrial hoist, industrial printer, packaging equipment, etc.
  • 2. Hazardous machinery : similar machinery, such as circular saws, products for underground work, such as presses, plastics, rubber ejectors, mines, car lifts for work, lifts for passenger transport, safety relays, etc.

• CE Machinery Directive(2006/42/EC)

  

  ✤ Composition of CE Machinery Directive(2006/42/EC)

  Introduction : Guidelines and general explanations and cautions for preparation
  Main subject : A provision for the application of guidelines, legal obligations or authority to the member countries

  • Annex I : Essential requirements for health and safety regarding design and manufacturing
  • Annex II : Matters concerning the Declaration of Conformity
  • Annex III : CE – Marking
  • Annex IV : List of machinery that must be tested in the EU format by the Notified Body
  • Annex V : Declaration of Conformity and Technical Files
  • Annex VI : EU Type Test
  • Annex VII : Notified Body Criteria

  ✤ Standard classification

  European Standard for machine safety can be divided into A, B, and C standard. The product must meet all 3 applicable standards.

  • Standard A (EN 414, EN 12100)

    Standard that define basic concepts, design principles, and general aspects as basic safety standard

  • Standard B (EN 13850, EN 13849-1, EN 60204-1 and etc.)

    Safety-related standard applicable to machines that are widely classified according to their basic use and purpose.

    • 1) Standard B1 for specific safety aspects (Electricity, Safety Distance, Surface Temperature, Noise and etc.)
    • 2) Standard B2 for safety-related devices and mechanical components (emergency switches, pressure sensing devices and etc.)
  • Standard C

    Standard that specify detailed safety requirements for a particular machine or group of machines.

  ✤ Applied Devices

  • 1. Products with at least one operating part, with electricity, air pressure, hydraulic pressure, weight and etc. as the source of energy
  • 2. Parts of machinery that are involved in health or safety; equipment that is shipped on separateness

  ✤ CE Machinery Directive(2006/42/EC) core requirement

  The documentation requirements that the manufacturer must comply with are in the essential health and safety requirements of Annex I of the MD, documenting whether the machine is being used safely and properly alerting the user if any remaining risks are present
  
  Required requirements as below :

  • 1. the principle of safety, design that facilitates handling, Ergonomics, Control system, Protects against mechanical hazards, electrical and other energy temperatures, other hazards, such as fire and explosion, common to all types of machinery, such as noise emission, Vibration, Radiation and hazardous materials, maintenance and maintenance, Cleaning, Display and Warning of Information
  • 2. Requirements applicable to certain classes of machinery, such as food, cosmetics, and medicines
  • 3. Requirements for offsetting the risk of machine mobility
  • 4. Requirements to offset the risk of lift operations
  • 5. Requirements for underground work machines
  • 6. Requirements for mechanical lift personnel

  ✤ The certification procedure

  There are four methods as follows :

  • A) High-risk machinery described in Annex 4

    Accreditation through the notified Body (NB)

  • B) General machinery other than Annex 4 (Anex II A)

    Acquired by Declaration of self-conformity (with a CE mark as proof of conformity with the finished product)

  • C) Declaration of self-conformity with respect to Machine Parts (Annes II B)

    Acquired by self-compliance declaration (with a CE mark as proof of conformity with the finished product)

  • D) Declaration of self-conformity with safety components (Annes II C)

    Acquired by self-compliance declaration (with a CE mark as proof of conformity with the finished product)

  Note: In the case of B) and C), a Declaration of self-conformity can be made and the relevant technical documents stored to declare compliance with the specification, but CE marks cannot be affixed to the product or packaging.

• Related document

  

  ✤ TCF: Technical Construction Files

  Technical Construction Files requirements contained in 2006/42/EC Annex VII. The TCF should verify that the machine is suitable for the requirements of the Machinery Directive. The language used must be written as the official community language.
  
  TCF should include the following documents :

  • General description of the machine
  • Technical drawings necessary to check the overall drawings of the machine and the suitability of the machinery
  • List of essential health and safety requirements applicable to machinery
  • Explanation of protective measures taken to reduce identified risks, instructions on residual risks associated with machinery
  • Standards that present the essential health and safety requirements contained in this standard
  • A report showing the results of a test performed by a manufacturer or by an agency recognized by the manufacturer
  • Copy of EC Declaration of Conformity for Machinery and Other Products

  Technical documents shall be available for at least 10 years from the date of manufacture of the machine.

  ✤ EC -Declarative of Conformity

  To attach a CE mark, the manufacturer must issue a declaration of conformity indicating that the product conforms to the applicable guidelines and standard regulations. Most machine manufacturers can declare their own suitability. Several product categories, including high-risk machines such as electrical saws, require third-party certification.
  
  Forced safety certification is carried out to ensure the safety of workers by using the machine properly and safely designing and properly installing products and maintaining the machine, due to numerous accidents caused by the use of the machine.
  
  The manufacturer shall prepare and sign the EU Declaration of Conformity, and the DOC shall include the applied Harmonized Organization and the information of the manufacturer, European representative and certification authority, and, if necessary, additional information such as harmonized specifications, products and technical specifications.
  
  Like the technical documentation, DOC should be stored for 10 years from the time the product is released. DOC's storage obligations are to the manufacturer or to the European representative, and in the case of imported products, the importer is responsible.
  
  DOC should include the following :

  • The name and full address of the manufacturer and, if applicable, the representative's information which recognized by the manufacture
  • Names and addresses of persons authorized to edit technical documents
  • Description of machinery including general information including functions, models, serial numbers, and trade name
  • Statement by which the machinery clearly declares that these guidelines have carried out all relevant regulations
  • Similar statements declaring other guidelines and/or related regulations appropriate for machinery, if applicable
  • Name, address and identification number of Notified body and number of certificates
  • Criteria for harmonized standard
  • Criteria for other technical standards and specification
  • Site and date of certification
  • The status and signature of a manufacturer or a person entrusted to prepare a declaration on behalf of a manufacturer's recognized representative

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  IGC works with European Notified Body (NB) to provide product certification services such as CE Machinery, CE MDD, CE IVD and CE LVD.
  
  IGC have years of technical skills and expertise, as well as up-to-date knowledge of a range of specific legal requirements in major markets around the world.
  
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