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Machinery Products

The latest version of the Machinery Directive (2006/42/EC) - Mechanical CE Certification

1.The latest version of the Machinery Directive (2006/42/EC) - Preface - Mechanical CE Certification   
On May 17, 2006, the European Parliament and the European Council formally adopted the latest version of the Machinery Directive (2006/42/EC), which is one of the basic laws on health and safety established by the European Union in accordance with the new method (Newapproach). Compared with the current Machinery Directive 98/37/EC, the new directives have obvious changes in the scope of application, boundaries with other guiding laws, market surveillance, safety components, conformity assessment procedures, and basic health and safety requirements.In the face of new technical barriers, relevant departments and enterprises should conduct research in advance and actively respond to them from the perspective of practical application and technology.
The new Act consists of a text and 12 annexes,  the text including: applicable mechanical scope, noun concept definition, market surveillance, market launch and delivery, qualification presumptive and harmonized standards, handling of potentially dangerous machinery-specific measures, coordination of standard disputes, Protective clauses, mechanical compliance assessment procedures, mechanical semi-finished parts, complete mechanical device procedures, designated certification bodies, CE marking, revision instructions for Directive 95/16/EC, etc. Number of clauses is 29. The accessories mainly include: basic health and safety requirements related to mechanical design and manufacture, mechanical qualification declaration requirements, CE mark, mechanical category daily record of implementation conformity assessment, safety component list, mechanical semi-finished part, complete mechanical assembly instructions Requirements, technical documentation requirements, conformity assessment of internal audits of mechanical manufacturing processes, EC type tests, perfect quality assurance procedures, and minimum standards to be considered by each member when designating a certification body.   
The content of the whole decree is refined in various aspects. At the same time, the articles that describe the same content in the original 98/37/EC Directive are grouped into separate clauses. The entire legal document framework is more explicit and helps manufacturers, certification bodies, and member states and the other relevant parties to understand and apply the content of the decree.

2.Legislative basis for the latest version of the Machinery Directive (2006/42/EC) - Mechanical CE Certification
The Machinery Directive 2006/42/EC is one of a series of measures based on Article 95 of the New EU Treaty (EcTreatv) (former Article 100). The main purpose of Article 95 of the EU Treaty is to achieve a single Mechanical safety and health requirements set forth in the European market. The development of the new Machinery Directive takes into account the proposals from the European Commission and the opinions of the European Economic and Social Committee. The purpose of this revision of the Machinery Directive is to propose a better definition of the various concepts in order to clarify the relevant issues and better ensure the uniform application of the guiding laws and regulations, to ensure the free circulation of products within the EU, while ensuring a high level about health and safety and consumer protection.
The earliest mechanical safety directive was 89/392/EEC, and 9l/368/EEC added the mobile machinery and the lifting and unloading for loading goods which the original directive was not mentioned. The 93/44/EEC added the requirements for manned elevators which not covered in former elevator order. 98/37/EC added provisions for CE marking, documentation and information on conformity declarations, and increased mandatory requirements. The new Directive 2006/42/EC is currently in force and will be officially implemented on December 29, 2009, in which the requirements for portable ammunition for fixed instruments and other impact machines will be postponed until July 29, 2011.

3.The latest version of the Machinery Directive (2006/42/EC) - The scope and definition of the Machinery Safety Directive - Mechanical CE Certification
Unlike the Directive 98/37/EC, the new Directive not only excludes a set of mechanical equipment, but also specifies the applicable mechanical products. The scope of the new directives will be expanded, hoists used in building construction site, ammunition-driven fixtures and other impact-type machinery will no longer be excluded. At the same time, the coverage of the new directive clearly excludes the motor, reducing the uncertainty in the manufacturer's management.The distinction between new instructions and LowVoltage instructions is no longer based on the “Main Risk” (MainRisk), where the six categories of electronic and electrical products listed are covered by the Low Voltage Directive, while other machines are covered by the Low Voltage Directive, but Conformity assessment procedures and market placement are governed by mechanical instructions.
 The line between the new directive and the LiftsDirective has also been clarified, in which elevators with a lifting speed of no more than 0.15 m/s are classified as mechanical safety directives. Applicable products of the Directive:
 (a) Machinery and equipment;
 (b) Interchangeable equipment;
 (c) Safety components;  
 (d) lifting accessories;
 (e) Chain, rope, wire mesh;
 (f) Removable mechanical transmission;
 (g) the partially completed mechanical part of mechanical semi-finished products.
Products explicitly stated in the Directive that are not within the scope of the Directive:
  (a) Safety components supplied by the original mechanical equipment manufacturer as spare parts for specific components.
  (b) Special Equipment used in stadium and/or amusement park。
  (c) Mechanical equipment specially designed or delivered for nuclear use, the failure of which produces nuclear radiation。
 (d) Weapons, including guns.

 (e) The following transportation tools:
 ——Agricultural and forestry tractors covered by Directive 2003/37/EC, except for machinery loaded on them;
  ——Directive 70/156, motor vehicles and their trailers covered by the EEC, except for machinery loaded on them;
  ——Except for machinery loaded on vehicles covered by Directive 2002/24/EC;
  ——Motor vehicle dedicated to competition;
  ——Transportation means for aviation, waterways and railways, except for machinery loaded on these means of transport.
  (f) Nautical vessels, mobile offshore equipment and mechanical equipment mounted on their boards.
  (g) Specialized mechanical devices for military and police use.
  (h) Mechanical equipment specially designed and manufactured for the temporary not in service laboratory.
 (i) winch for mine。
 (i) Mechanical device for moving actors in artistic performances.
 (k) The following electrical and electronic products contained in Directive 73/23/EEC(Council Directive on harmonizing the laws of Member States relating to electrical equipment operating within a specific voltage range, promulgated on February 19, 1973):
 ——Household appliances;
 ——Audio and video equipment;
 ——information technology equipment;
 -—General office machinery;
 ——Low voltage switchgear and control unit;
 ——Electric motor。
 (z) The following types of high voltage electrical equipment:
 ——Switching device and control device;
 ——transformer.
 Relationship with other instructions:
If the relevant hazard in Annex I mentioned in the Directive is covered, in whole or in part, by a specific EU Directive, the Directive shall not apply or be terminated from the date of execution of the other Directive.。
 The definition adopted by the guiding decree:
 (a) Machinery and equipment:
 (I) Mechanical devices that are assembled with or ready to be assembled with the drive system, do not operate directly by human or material forces, including components for connection,there is at least one moving part in the component that is assembled for a specific use;
  (II) The mechanical devices mentioned in (I) above are simply missing components that can be connected or connected to the power source in the field;
  (III) The mechanical devices mentioned in the above paragraphs (1) and (II) have been prepared for installation and can only perform their original functions when installed on a vehicle, building or structure;
  (Iv) The mechanical device or mechanical semi-finished part mentioned in the above section (I), (II), (III) completes the mechanical combination device, and is arranged and controlled to function as a whole for the same purpose;
  (v) A combination of parts or components for connection, at least one of which is assembled and assembled to be used to lift heavy objects. The only source of power is direct use of manpower. 
(b) Interchangeable equipment:
After the mechanical device or tractor is delivered, the operator assembles the device with the device or the tractor to change its function or obtain a new function, but the interchangeable device is not a tool.
  (C) Security component is a component:
  ——Used to implement security features;
  ——Independently placed on the market;
  ——Its failure and / or lack of agility will threaten people's safety;
  ——Not necessarily required for the operation of the mechanical device, or can be used to replace the normal components.
  (d) Lifting machinery attachment refers to a component or equipment that is not attached to a lifting machine and can be used to fix a load. It is usually placed between the lifting machine and the load or placed on the load; it can also be intended to form an integral part of the load and independently placed on the market; slings and their components are also known as attachments to lifting machinery.
  (e) Chains, ropes and screens are chains, ropes and screens designed and manufactured for lifting purposes as components of lifting machinery or as attachments to lifting machinery.
  (f) The movable mechanical transmission refers to the detachable power transmission assembly between the automatic propulsion machinery (or tractor) and other machines. The automatic propulsion machinery (or tractor) and other machines are first connected by fixed bearings. When this device is put on the market with a protective device, it will be considered as a product.
  (g) Mechanical semi-finished partially finished machine refers to a connecting component or mechanical component that is assembled with or to be assembled with a transmission device. This device is basically a complete machine, but they cannot be used for their specific purpose. Partially completed mechanical devices are typically used in conjunction with one or more mechanical devices (or other partially completed mechanical devices) to form a single mechanical device within the scope of this Directive.
  (h) Launching the market means that the mechanical device will be launched on the market for the first time, regardless of whether the purpose of the launch is to provide it as a prize or to provide it for free.
  (i) Manufacturer means any natural person or legal person who designs or manufactures mechanical devices or mechanical semi-finished products contained in this Directive and is responsible for complying with the requirements of this Directive for its mechanical devices or semi-finished products. These machines are placed under their own names or trademarks,go to the market or use it by themselves. In the absence of the manufacturer mentioned above, any mechanical device or semi-finished product contained in this Directive will be placed on the market or delivered for use as a manufacturer.
  (i) An authorized representative is any natural or legal person identified within the European Union region that is executed by the manufacturer in writing or in full or in part with all or part of its obligations or formalities with respect to this Directive.
  (k) Delivery is the first use of the mechanical equipment covered by the Directive within the EU for its intended use.
  (Z) Coordination standards refer to non-binding technical specifications approved by the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC) and the European Telecommunications Standards Institute (ETSI), after the authorization of the European Commission, in accordance with Directive 98/34/EC of the European Parliament and the Council of the European Union on the provision of information procedures in the areas of technical standards and information society services regulations on June 22, 1998 .
 The new concept definition in the directive is useful for a clear explanation of the terms in the text, such as safety components,The original Directive 98/37/EC text has only a general definition of it, and the lack of a clear definition has led to many interpretations of the terms of the application. The new directive not only gives a clear definition, but also gives a detailed list by way of example. With the advancement of technology, the Machinery Committee has the right to revise this list to cover new products.

4. The latest edition of the Machinery Directive (2006/42/EC) - Market surveillance and conformity assessment
The new Directives refine the terms related to market surveillance and the terms related to compliance certification body notifications.
The new directive stipulates that EU members are also obliged to supervise the performance of certification bodies. Member States have the right to revoke and suspend the institution's eligibility if they are found to have failed to perform their duties adequately. At the same time, it stipulates more clearly the responsibility of member states to carry out market supervision. Their obligations include mutual cooperation and respect for confidentiality and transparency.
The mechanical conformity assessment procedure adds an internal audit compliance assessment for the mechanical manufacturing process and perfect quality assurance procedures based on the original EC type test.
There are two requirements for the mechanical qualification of mechanical semi-finished parts:(1) Make an assembly statement for the mechanical equipment;(2) Supplied with assembly instructions。
It can be seen from the above that the new directive has clearly defined the manufacturer's internal manufacturing measures, and the new directives have begun to intervene in the assessment of the company's quality assurance system. These are issues that manufacturers must pay attention to.
5. Revision of Directive 95/16/EC
 The new Machinery Directive partially revised the elevator directive 95/16/EC,mainly:
  (1) The concept definition of the carriage is added, and in the first chapter, "carriage" is used instead of "car" to make the content of the decree more practical.
  (2) Add mechanical equipment that is not covered by it:
  ——Mechanical equipment with lifting speed not exceeding 0.15m/s;
  ——Escalators and mechanical walkways。
  (3) Section 1.2 of the basic health and safety requirements becomes a requirement for a transport vehicle (carrigae-)。

6. The latest edition of the Machinery Directive (2006/42/EC) - basic health and safety requirements
 Among the new directives, the changes in basic health and safety requirements are mainly:
  (1) The special requirements in Directive 98/37/EC for hazards due to the movement of mechanical moving parts or lifting machinery have been extended to apply to all machines, in particular:
 ——Sudden movement during handling;
  ——Specific terms related to multiple specific terms;
  ——The danger of lightning。
  (2) The relevant requirements of the manual are more detailed and easier to understand.。
  (3) Warnings about specific hazards are added to each chapter to alert the user to the fact that the machine must meet all basic health and safety requirements.
  (4) Specific requirements for newly added mechanical devices. The new directive also adds additional requirements for the following special categories of machinery:
  (1) Food machinery and cosmetics or pharmaceutical production machinery;
  (2) Portable hand and/or hand control machinery;
  (3) Mechanical equipment for processing wood or similar physical parameter materials;
  (4) Mechanical equipment that is dangerous due to its movement or work;
  (5) Dangerous mechanical equipment due to lifting operations;
  (6) Mechanical equipment intended for underground work;
  (7) mechanical equipment that have special dangerous when Lifting and transporting personnel.

7.The latest version of the Machinery Directive (2006/42/EC) - the type of machinery for mandatory compliance assessment
  (1) Processing of wood and similar physical parameter materials, or circular saws (single or multi-blade) for processing meat and similar physical parameter materials.
  (2) Manual feeding woodworking flat planer.
  (3) Single-sided thick-plate planer for woodworking, with mechanical workpiece feeding device for manual loading and unloading of workpieces.
  (4) Processing of wood and similar physical parameter materials, or band saws for processing meat and similar physical parameter materials.
  (5) For combined machinery for processing wood and similar physical parameter materials, the machinery described in paragraphs (1), (2), (3), (4) and (7) of this section may be used as a combined mechanical device.
  (6) Manual feeding multi-tool holder woodworking machine.
  (7) Manual feed vertical axis milling machine for processing wood and similar physical parameter materials.
 (8) Hand chain saw for woodworking.
 (9) Hand-loaded metal cold working press (including bending machine), the movable working part stroke can reach more than 6mm, and the moving speed exceeds 30mm/s.
  (10) Manual injection molding or compression molding machine.
  (11) Manual injection molding of rubber injection molding or compression molding machines.
  (12) The following mechanical equipment for underground work:
  ——Locomotive head and brake car;
  ——Hydraulic drive top frame.
  (13) Manually loaded trucks that collect household waste with compaction mechanisms.
  (14) Detachable mechanical transmission with guards.
  (15) Guards for detachable mechanical transmissions.
  (16) Vehicle servicing lifts.
  (17) A manned or manned load lifting device with a risk of falling from a vertical height of more than 3 meters.
  (18) Portable ammunition pushes fixed instruments or other impact mechanical equipment.
  (19) A protective device designed to detect the presence of a person.
  (20) The power-driven interlocking movable protection device for mechanical protection described in the paragraphs (9), (10), and (11).
  (21) A logical device that ensures safety functions.
  (22) Roll Over Protection System (ROPS)。
  (23) Falling Object Protect Structure (FOPS)。

8. The latest version of the Machinery Directive (2006/42/EC) - List of safety components
The following list of safety components given by the new Machinery Directive can be updated to cover new products based on the level of industrial development and technological advancement:
  (1) Guards for detachable mechanical transmissions.
  (2) A protective device designed to detect the presence of a person.
  (3) Power-driven interlocking movable guard for mechanical protection described in mandatory compliance assessment of categories (9), (10), (11).
  (4) A logical device that ensures safety functions.
  (5) Valves with additional measures for fault detection are intended for the control of mechanical hazardous motion.
  (6) Mechanical emissions collection system.
  (7) Protection and protection devices designed to protect personnel from moving parts during mechanical work.
  (8) Monitoring equipment for lifting machinery loading and motion control.
  (9) Constraint system designed to maintain personnel in the operating seat.
  (10) Emergency stop device.
  (11) A discharge system that prevents the accumulation of potentially dangerous electrostatic charges.
  (12) The energy limiter release device mentioned in clauses 1.5.7, 3.4.7 and 4.1.2.6 of Annex 1 of the new Directive.
  (13) System unit that reduces noise and vibration emissions.
  (14) Roll Over Protection System (ROPS)。
  (15) Falling Object Protect Structure (FOPS)。
  (16) Two-hand control device.
  (17) Designed for use in machinery used to lift and transport people between different platforms.


9.The latest edition of the Machinery Directive (2006/42/EC) - a complete quality assurance procedure 
The requirements for the manufacturer's quality assurance system introduced by the new directive are very detailed. When the manufacturer adopts this procedure for mechanical compliance assessment, relevant requirements of quality management system must be met in mechanical design, manufacturing, final inspection and testing processes  and the supervision of the designated agency must be accepted.
The manufacturer or its authorized representative must submit an application to the designated certification body for the assessment of its quality system.
The implementation of the quality system must ensure that the mechanical equipment complies with the relevant requirements of this Directive. All elements, requirements and provisions adopted by the manufacturer for its quality system must form a systematic and orderly quality document in the form of measures, procedures and written instructions.
The quality system document harmonizes its procedures and quality measures, such as quality plans, quality plans, quality manuals and quality records. The quality system documentation should specifically describe the quality objectives, organizational structure, technical design specifications, inspection and verification procedures for mechanical design, inspection and quality assurance techniques at the manufacturing stage, tests and tests to be performed before, during and after manufacturing, and Frequency, quality record, quality assurance of mechanical design and manufacturing, and supervision methods for the effective operation of the quality system.
The designated certification body will review the manufacturer's quality system and inform the manufacturer of the decision it has made, after passing the audit of the notified body, the manufacturer will also be supervised by the designated agency.The designated certification body will conduct a quality system review of the manufacturer every three years and submit a review report.In addition, the notified body may also conduct an inspection of the manufacturer without prior notice and conduct on-site testing if necessary.At the end of the interview, the manufacturer will be provided with a visit report and a test report.

10.The latest version of Machinery Directive (2006/42/EC) - Other regulations (marketing requirements, CE marking, harmonized standards, etc.)
The mechanical equipment or semi-finished products involved in this Directive may only be placed on the market if properly installed, assembled, repaired, used according to the intended use and not endangering the health and safety of humans, livestock and property.
It is required that the CE mark be clearly and clearly attached to the mechanical equipment, while avoiding other signs that are confused with the CE mark. For machinery that does not meet the requirements for labeling, EU member states will require the manufacturer or its authorized representative to make corrections.If there is still a non-conformity after the rectification, the EU members will just take appropriate measures to restrict or prohibit the problem machine from being put on the market or recall it from the market.
The Machinery Safety Directive mandates that EU member states convert them into national laws within a certain period of time.At the same time, the Directive states that machinery and equipment complying with the harmonized standards published in the Official Journal of the European Union may be considered to comply with the requirements of the relevant part of this Directive covered by the harmonized standards, therefore, although the harmonized standards are not mandatory, they play an important role in the implementation of this Directive.