• Overview of CE

    The CE mark, or formerly EC mark, is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985. The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA.
    And also, CE logo might contain 4 numbers which stand for Notified Body number.
    The actual words signified by "CE" have been disputed. It is often taken to be an abbreviation of Conformite Europeenne, meaning "European Conformity". However, "CE" originally stood for "Communaute Europeenne", French for "European Community".
    CE mark means the products satisfy the requirements of EU board directive which related to the safety, health, environment and the consumer protection. So CE mark should be attached on the products sold within the European Economic Area (EEA)

    • 1. If manufacture declares the products are suitable for Safety/ Health/ Environment rules of EEA, CE mark can be attached on the products.
    • 2. CE mark guarantees the products are legally distributed domestically.
    • 3. CE mark proves the manufacture can trade freely in EEU.
  • Countries

    27 countries of EU (European Union) and 4 countries of EFTA(European Free Trade Association): France, Netherlands, Greece, Germany, Luxembourg, Italy, England, Ireland, Denmark, Belgium, Portugal, Austria, Sweden, Finland, Poland, the Chez Republic, Hungary, Estonia, Latvia, Lithuania, Slovakia, Slovenia, Malta, Bulgaria, Rumania, Norway, Iceland, Switzerland.

  • Conformity Assessment Module

    Conformity Assessment Module
    Module A Design and Safety Management of products are controlled by the Manufacture No intervention of Notify Body.
    Module B Design and Samples of the product are shipped to Notified Body for Testing.
    Module C The manufacture guarantees continuous manufacturing of the product which examined according to Module A. No intervention of Notify Body.
    Module D Notify Body approves the procedure of Manufacturing, Final test and Test quality in accordance with Module B.
    Module E Notify Body approves the Final test and the Test quality of products which examined according to Module B.
    Module F Notify Body type-examines or approves the Safety Design for manufacturing the same products which examined according to Module B.
    Module G Notify Body inspect and approves all of unit production.
    Module H Notify Body approves the Design, Manufacturing and Final test according to ISO 9001.
  • Process

    Conformity assessment procedure according to Global Approach

  • Directive

    Directive
    EU DIRECTIVE TITLE Object Item
    Base:2006/42/EC
    2009/127/EC
    Machinery Directive (MD) Machinery
    2014/35/EU Low Voltage Directive (LVD) Electric and Electronic Product (50-100Vac,75-1500Vdc)
    2014/30/EU ElectroMagnetic Compatibility Directive (EMCD) Most electronic products having an electromagnetic wave generated
    Base:93/42/EEC
    2007/47/EC
    Medical Devices Directive (MDD) Class I, Class Im or Is, Class IIa, Class IIb, Class III
    2014/33/EU Lifts Directive (LIFT) Lift, Safety components
    2014/34/EU Equipment for Explosive Amospheres (ATEX) Explosion Proof Products
    2009/48/EC Toys safety Directive (TOYS) Toys
    2009/142/EC Gas appliances(GAD) Gas appliances
    2014/53/EU Radio equipment (RED) wireless communication device
    96/58/EC Personal Protective Equipment Directive (PPE) Personal Protective Equipment
    2014/68/EU Pressure Equipment Directive (PED) Category I, Category II, Category III, Category IV
    2013/53/EU Recreational craft and personal watercraft (CRAFT) Recreational vessels
    2000/14/EC Noise emission Directive Outdoor Equipment Noise regulatory guidelines
    2014/29/EU/td> Simple Pressure Vessels Directive(SPVD) Simple Pressure Equipment Directive
    Base:92/42/EEC
    2005/32/EC
    Ecodesign - Hot-water boilers Guidelines for hot water boiler efficiency
    2010/35/EU Transportable pressure equipment Portable Pressure Equipment Directive
    2009/9/EC Cableway installations designed to carry persons People ropeway transport installation design guidelines
    Base:89/665/EEC
    2007/66/EC
    Safe operation and use of machines, technical equipment, instrument and tools Guidance on use of the work mechanism
  • Procedure of Certificate

    Procedure of Certificate
    Examination product Directive check and issue Proposal.
    • User Manual is required.
    Application Proposal Check and Apply
    • Application form should be filled by manufacture.
    Check all documents Check all documents
    • Part list, English Manual (Safety, operational, transportation, installation, maintenance)
    Tests Tests
    • Product structure examination.
    • Product Test according to the Directive.
    Technical Files Technical Files
    • Technical Report is required.
    • Declaration of Conformity, Risk Analysis, test protocols, photo, part list, manual, drawing
    Notify Body Review Italy review
    • Technical report review
    • Issuance Certificate
    Certificate Original Certificate
    • Present Certificate
  • LVD


    Overview

    • a) For the purposes of this Directive, ‘Electrical equipment’ means any equipment designed for use with a voltage rating of between 50 and 1000V for alternating current and between 75 and 1500V for direct current.
    • b) Equipment and Phenomena outside the Scope of this Directive
      • Electrical equipment for use in an explosive atmosphere
      • Electrical equipment for radiology and medical purposes
      • Electrical parts for goods and passenger lifts
      • Electricity meters
      • Plugs and socket outlets for domestic use
      • Electric fence controllers
      • Radio-electrical interference
      • Specialized electrical equipment, for use on ships, aircraft or railways, which complies with the safety provisions drawn up by international bodies in which the Member States participate.

    Typical Standards

    • EN 60335-1 : Household and similar electrical appliances - Safety - Part 1: General requirements
    • EN 60950-1 : Information technology equipment - Safety - Part 1: General requirements
    • EN 61010-1 : Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 1: General requirements
    • EN 60947-1 : Low-voltage switchgear and control gear - Part 1: General rules
    • EN 62233

    Essential safety requirement

  • EMC


    Overview

    EMC means all the electric/ electronic equipments which include electronic parts and facilities. And EMC contains any equipment which interrupts near equipments and its function.


    대표적인 Standards

    • EN 55014-1 : Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 1: Emission
    • EN 55014-2 : Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 2: Immunity - Product family standard
    • EN 55022 : Information technology equipment - Radio disturbance characteristics - Limits and methods of measurement
    • EN 55024 : Information technology equipment - Immunity characteristics - Limits and methods of measurement
    • EN 61000-3-2 : Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions(equipment input current ◀ 16 A per phase)
    • EN 61000-3-3 : Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ◀ 16 A perphase and not subject to conditional connection

    적합성평가


    Essential safety requirement

    • Protection requirements

      Equipment shall be so designed and manufactured, having regard to the state of the art, as to ensure that:

      • 1. the electromagnetic disturbance generated does not exceed the level above which radio and telecommunications equipment or other equipment cannot operate as intended;
      • 2. )it has a level of immunity to the electromagnetic disturbance to be expected in its intended use which allows it to operate without unacceptable degradation of its intended use.
    • Specific requirements for fixed installations

      Installation and intended use of components
      fixed installation shall be installed applying good engineering practices and respecting the information on the intended use of its components, with a view to meeting the protection requirements set out in Point1. Those good engineering practices shall be documented and the documentation shall be held by the person(s) responsible at the disposal of the relevant national authorities for inspection purposes for as long as the fixed installation is in operation.

  • R&TTE


    Overview

    To manufacture or sell radio and telecommunication equipment for use in Europe it must comply with R&TTE Directive 1999/5/EC. With a few exceptions it applies to all equipment that uses the radio frequency spectrum.
    The R&TTE Directive harmonizes the telecommunications market and improves the process of bringing products to market. Removing national standards the directive now requires manufacturers to demonstrate that a product meets the directive’s Essential Requirements.


    대표적인 Standards

    • Product safety: EN 60950-1, EN 60215, EN 60825-1, EN 60529
    • EMC EN 301 489, EN 301 502, EN 301 908, EN 61000-3-2, EN 61000-3-3
    • Radio EN 300 220/330/440 (Short Range Devices), EN 300 328 (2.4GHz ISM Band), EN 301 511 (GSM Mobile Station), EN 301 908 (UTRA & E-UTRA), EN 301 893 (5GHz RLAN), EN 302 291 (13.56MHz SRD)
  • ATEX


    Overview

    It is the duty of Member States to protect, on their territory, the safety and health of persons and, where appropriate, domestic animals and property and, in particular, that of workers, especially against the hazards resulting from the use of equipment and systems providing protection against potentially explosive atmospheres.


    Type of explosion protection

    Type of explosion protection
    Electrical Symbol Zones Standard
    General EN IEC 60079-0
    Flameproof d 1,2 EN IEC 60079-1
    Intrinsic safety ia
    ib
    ic
    0,1,2
    1,2
    2
    EN IEC 60079-11
    Non-electrical symbol zones standard
    General EN 13463-1
    Flameproof enclosure d 1,2,21,22 EN 13463-3
    Intrinsic safety c 0,1,2,20,21,22 EN 13463-5

    Conformity Assessment


    Reference


    Classification and labeling of explosion proof areas

    Classification and labeling of explosion proof areas
    Flammable
    medium
    Hazardous locations Probability
    of a potential explosive
    atmosphere occurring
    Classification of
    explosion proof areas
    Product classification
    Product group Product category
    Gases,
    Mists,
    Vapoirs
    Always, temporarily or often present Zone 0 II 1G
    Occasionally present Zone 1 II 2G
    Very seldom or only present for a short period Zone 2 II 3G
    Dusts Always, temporarily or often present Zone 20 II 1D
    Occasionally present Zone 21 II 2D
    Does not occur or only seldom for a short period Zone 22 II 3D

    Protection principle - type of protection

    Protection principle - type of protection
    Protection principle Type of protection Code Symbol To use in zone Standards
    Prevents transmission
    of the explosion outside
    Flameproof enclosure Ex d 1,2 EN 60079-1
    Prevents high
    temperatures and sparks
    Increased safety Ex e 1,2 EN 60079-7
    Low current/
    voltage supply
    Intrinsic safety Ex i
    Ex ID
    1,2
    20,21,22
    EN 60079-11
    Positive Pressure
    device
    Pressurized
    apparatus
    Ex p
    Ex pD
    1,2
    21,22
    EN 60079-2
    Encapsulated moulding Ex m
    Ex mD
    0,1,2
    20,21,22
    EN 60079-18
    Parts immersed
    in oil to isolate
    from explosive atmosphere
    Oil immersion Ex o 1,2 EN 60079-6
    Prevents
    transmission of
    explosion outside
    Powder filling Ex q 1,2 EN 60079-5
    As above,
    but for use
    in zone 2
    Protection "n" Ex n 2 EN 60079-15
    Dust explosion
    proof
    Protection ”tD” Ex t 20,21,22 EN 60079-31

    Classification explosion groups & Temperature classes

    Classification explosion groups & Temperature classes
    Explosion group Examples depending on
    IIA IIB IIC Ammonia
    Methane
    Ethane
    Propane
    Ethanol
    Cyclohe-xene
    n-Butane
    Petrol
    Diesel fuel oil
    n-Hexane
    Acetal-de-hyde        
    Ethylene
    Ethylene oxide
    Ethyl glycol
    Carbon
    hydrogen
    Ethyl ether
    Hydrogen Acetylene Carbon
    disulphide
    T1<450 ℃
    T2<300 ℃
    T3<200 ℃
    T4<135 ℃
    T5<100 ℃
    T6<85 ℃

    Zone

  • Machinery


    Overview

    • Safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery
    • Specific equipment for use in fairgrounds and/or amusement parks
    • Machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity
    • weapons, including firearms

    제품 분류

    • Circular Saws: Sawing machines
    • Hand-fed surface planning machinery for wood working
    • Thicknessers for one-side dressing
    • Band-saws
    • Combined wood working machinery
    • Hand-fed tenoning machinery
    • Hand-fed vertica spindle moulding machinery
    • Portable chain saws for wood working
    • Presses, including press brakes, for the cold working of metals,
    • Injection or compression plastics-moulding machinery with manual loading or unloading.
    • Injection or compression rubber-moulding machinery with manual loading or unloading. Etc

    Standards

    • 1. A-type standards
      A-type standards specify basic concepts, terminology and design principles applicable to all categories of machinery. Application of such standards alone, although providing an essential framework for the correct application of the Machinery Directive, is not sufficient to ensure conformity with the relevant essential health and safety requirements of the Directive and therefore does not give a full presumption of conformity. (EN ISO 12100:2010)
    • 2. B-type standards
      B-type standards deal with specific aspects of machinery safety or specific types of safeguard that can be used across a wide range of categories of machinery. Application of the specifications of B-type standards confers a presumption of conformity with the essential health and safety requirements of the Machinery Directive that they cover when a C-type standard or the manufacturer's risk assessment shows that a technical solution specified by the B-type standard is adequate for the particular category or model of machinery concerned. Application of B-type standards that give specifications for safety components that are independently placed on the market confers a presumption of conformity for the safety components concerned and for the essential health and safety requirements covered by the standards.
    • 3. C-type standards
      C-type standards provide specifications for a given category of machinery. The different types of machinery belonging to the category covered by a C-type standard have a similar intended use and present similar hazards. C-type standards may refer to A or B-type standards, indicating which of the specifications of the A or B-type standard are applicable to the category of machinery concerned. When, for a given aspect of machinery safety, a C-type standard deviates from the specifications of an A or B-type standard, the specifications of the C-type standard take precedence over the specifications of the A or B-type standard.
      Application of the specifications of a C-type standard on the basis of the manufacturers risk assessment confers a presumption of conformity with the essential health and safety requirements of the Machinery Directive covered by the standard. Certain C-type standards are organized as a series of several parts, Part 1 of the standard giving general specifications applicable to a family of machinery and other parts of the standard giving specifications for specific categories of machinery belonging to the family, supplementing or modifying the general specifications of Part 1. for C-type standards organized in this way, the presumption of conformity with the essential health and safety requirements of the Machinery Directive is conferred by application of the general Part 1 of the standard together with the relevant specific part of the standard.

    적합성 선언을 위한 절차


    필수안전요구사항

    *Essential health and safety requirements relating to the design and construction of machinery

  • PED


    Overview

    • a) This Directive applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0,5bar.
    • b) 'Pressure equipment' means vessels, piping, safety accessories and pressure accessories.
      Pressure equipment includes elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, lifting lugs, etc.
    • c) The following are excluded from the scope of this Directive :
      • Certain equipment which is very difficult to regulate(Pipelines, Nuclear Item etc.)
      • Equipment applicable to other directive (aerosol, dispensers etc.)
      • Equipment which do not occur serious damage by pressure
      • Fluid or material transport piping
      • Networks for the supply, distribution and discharge of water
      • Device including (simple pressure vessels: 2009/105/EC)
      • Vehicle equipment

    Typcal Standards

    • a) Material
      • EN 10204 : Metallic products - Types of inspection documents
    • b) Vessel
      • EN 13445-3 : Unfired pressure vessels (part 3 : Design)
      • EN 13445-5 : Unfired pressure vessels (part 5 : Inspection and testing)
    • c) Valves
      • EN 1984: Industrial valves - Steel gate valves
      • EN 593: Industrial valves - Metallic butterfly valves
      • EN 14341: Industrial valves - Steel check valves
      • EN 12266-1: Industrial valves - Testing of metallic valves - Part 1: Pressure tests, test procedures and acceptance criteria - Mandatory requirements
      • EN 12516-1: Industrial valves - Shell design strength - Part 1: Tabulation method for steel valve shells
      • EN 12516-2: Industrial valves - Shell design strength - Part 2: Calculation method for steel valve shells

    Conformity Assessment

    The Category of PED is classified as stage 4 by type of fluid, volume of vessels or diameter of Piping, etc

    Conformity Assessment
    Category I Module A
    Category II Module A1, D1, E1
    Category III Module B1+D, B1+F, B+E, B+C1, H
    Category IV Module B+D, B+F, G, H1

    Conformity Assessment
    Module A, A1
    (Internal production control)
    Safety management in the design and production of the manufacturer itself No legal intervention of the European Notify Body
    Module A1
    (internal production check)
    Module B, B1
    (EC type Examination)
    Submission and examination of designs and samples to Notified Body
    Module C
    (Conformity to type)
    The manufacturer ensure Continuous production of Safety products that have been inspected in accordance with Module B (No intervention of Notified Body)
    Module D,D1
    (Production quality assurance)
    Approval of final inspection and test quality procedure and Production process of products that have been inspected in accordance with Module B by Notified Body
    Module E,E1
    (Product quality assurance)
    Approval of final inspection and test quality procedure of products that have been inspected in accordance with Module B by Notified Body
    Module F
    (Product verification)
    Approval of the Safety Design for manufacturing the same products which examined according to Module B
    Module G
    (EC unit verification)
    Full inspection and approval by Notified Body for all of unit Production
    Module H,H1
    (Full quality assurance)
    Approval of maintenance of the Design, Manufacturing and Final test according to ISO 9001.

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