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1. EU Machinery Directive
The EU machinery directive is not aimed at technical details, but focuses on mechanical design and safety and health regulations related to the organization. The current Machinery Directive (98/37/EC, which was promulgated by the EU official gazette in July 23, 1998), replaces the 1989 issue of 89/392/EEC, and the subsequent revised directives 91/368/EEC, 93/44EEC and 93/63/EEC. Since January 1, 1995, the machinery directive has become a mandatory European law, and all EU member states have to incorporate some of their basic provisions into the laws of their respective countries.
The European Union Machinery Directive 98/37/EC applies to all kinds of machinery and safety parts sold in the market, but it is not applicable to some specific machinery. The complete specification of machinery directive, application release and CE markers including the declaration of conformity, also apply to second-hand or renovated machinery, including: the first import countries outside the EU, the European economic area to the new or renovated machinery used in the region. New machinery, assembled and disassembled from all over the world, has new design and new risks.

1) the machinery described in the mechanical instruction"
The machinery described in the mechanical instruction includes a single machine, a connected set of machinery, and a replaceable device.
1. mechanical assembly of several parts which connected, wherein at least one of the parts can be connected through proper motion, and brake control device and the power circuit, and a specific purpose, such as material processing, processing, handling, packaging, etc.. Mainly includes the following types of products: wood processing machinery, metal cutting machine tools, forging machinery, agricultural and forestry tractors and machinery, rubber and plastic machinery, packaging machinery, lifting transportation machinery, storage equipment, construction machinery, food processing machinery, heat treatment equipment, underground mining machinery, printing and papermaking machinery, casting machinery, textile machinery, washing machine, compressor, engine, pump, tanning machinery, fire fighting equipment etc.. For those machines which are packaged and disassembled for transport purposes, they shall be assembled together when they are used, so the instructions shall also be followed.
2., the mechanical combination, in order to achieve the same purpose, by a number of machines after proper configuration and control, to become a comprehensive whole, to achieve complete function. Such as automatic production line and flexible manufacturing system.
3. replaceable equipment refers to equipment that can be replaced, can change the mechanical function, the equipment can be put into the market, they will be used by the operator and one or a series of different mechanical traction machine assembly together, the device is not spare parts or tools. These devices can provide power, such as the end of a car mounted on a machine tool.
Mechanical instruction in the safety parts of the equipment above is not replaceable, it is sold by the manufacturer or its determination in the EuropeanCommunity authorized agents in the market, the implementation of security function in the use of spare parts, his failure would endanger the health or safety of exposure (here refers to the body exposure all or part of any personnel in the hazardous area). For example, the rope, emergency stop device, logic component with both hands control, electronic sensitive device, drop protection device and overload protection device designed for protection personnel.
2) machinery that is not suitable for mechanical instruction
The term "machinery" covers any kind of equipment, whether for domestic, commercial, or industrial use, consisting of parts that are powered by electricity rather than by human power. There are exceptions, however. Some machines are not included in the mechanical instructions, but are covered by other instructions. For example, when the mechanical risk is related to the power supply, it is included in the Low Voltage Directive (73/23/EEC). These machines are included in the low voltage directive standard issued by the official gazette.
Specifically, machinery that is not suitable for mechanical instruction:
Only taking human as a power source for lifting machinery, but the mechanical load to direct contact with patients; medical equipment; market places or (and) special equipment playground; tank and steam boiler, pressure vessel; mechanical and special design or application for nuclear use, in the event of failure, will cause radioactive radiation; the radioactive source of mechanical parts forming; light weapons; gasoline, diesel oil, nuclear tank pipeline of inflammable liquid and hazardous substances; transport, are those by aviation, highway, railway, waterway and other public transport network to transport. Passenger tool and trailer, and device for carrying goods by air, road, railway, waterway and other transportation network. The mining industry with the vehicle is allowed except; oceangoing ships and offshore mobile equipment, together with its equipment; public or private manned cableway (including cable car); 74/150/CEE (unified instruction on each member of wheeled agricultural or forestry tractor setting law) clause 1 (1) tractors for agriculture and forestry is defined as; military or police mechanical design and manufacturing;
A permanent lifting device for a particular height of a building, with a carriage moving between rigid rails, with the inclination of the guide rail and the horizontal plane greater than 15 degrees, designed to carry:

   1. personnel
2. personnel and goods
3. of the goods, but the car can enter, that people can easily enter the car, equipped with the controller in the car in the car or in the range of accessible; personnel transport device installation of the gear and the rack rail vehicle; mine hoist device; lift stage; construction site hoists transporting people or people and goods.
Is the CD player considered mechanical because of active components? Of course not. Although many products have different forms of moving parts, they are not included in the scope of the instructions. At the same time, "activity" must be due to external kinetic energy (electricity, batteries, fuel, etc.), or energy storage (spring, weight). In addition to this provision, the machinery directive covers some direct lifting equipment for human use. Other machines which are directly driven by manpower are not listed here. In addition, the main risks arising from the product must be mainly mechanical power, not electricity related.

2. requires a EC declaration of conformity and additional CE mark products
For the products included in the mechanical instructions, the CE mark is a mandatory sign. CE is abbreviated as Conformity European. Before legally binding the CE mark on the machine, the manufacturer must issue a "qualified statement" (Doc), which is the duly signed document, indicating the basic requirements for all applicable instructions. CE signs represent conformity to statutory specifications, neither quality nor safety signs. The CE logo can be placed on the machine with third party safety signs to show its principle of good faith. If there is no CE mark, has failed to comply with the provisions of the directive, products will not in the European Union and the European Economic Zone "on the market or put into use, however, if the product can meet the applicable provisions of the EU directive, will not be affected by these countries prohibit, restrict or prevent. As a result, the CE mark is considered a "pass" for the products to circulate in europe".

Product category
EC Declaration of Conformity
CE sign
Machinery (including single, mechanical, mechanical, combination, and replaceable equipment) Requirement Requirement

A machine that does not operate independently of a machine

Requirement Not required

 

3. requirements for the preparation of EC qualification statements
1. in the annex to the directive, II specifies the content to be included in the EC Qualification Statement. Generally speaking, the following contents are included:
The name and address of the manufacturer or its authorized agent in the European Community; information on the structure, type, sequence number, etc. of the product;
The product complies with the relevant instructions and, if necessary, includes the standards adopted;
Where necessary, it includes the name, address and relevant certification matters of the notified institution; the identity and signature of the authorized agent of the manufacturer or its common body in the European community;
For machinery that will not operate independently of a machine, the statement shall also state that "the machinery shall not be used until the machinery is incorporated into the machinery and that it has not yet been in conformity with this directive.""
2.EC qualification statements must be written in the same language as mechanical instructions. It is accompanied by the translation of the official language of the country of use of the machinery. The qualification statement should be typed and clearly written.

4. annex I: mechanical command core
For manufacturers, the "annex I" is the core and essence of the machinery directive ". "Annex I" not only provides a broad list of potential hazards caused by design and operation, but also provides general guidelines for avoiding those risks. The basic provisions in the mechanical instructions are as follows:
Basic health and safety requirements; for certain types of machinery; additional basic health and safety requirements (crop machinery, portable and / or manual machinery, wood and similar materials processing machinery);
Eliminates mechanical affects caused basic health and safety regulations especially dangerous; eliminates the lifting operation caused by the basic health and safety regulations especially dangerous; basic health and safety regulations for underground special machinery;

5. standard: a tool for proving compliance with instructions
Compliance with applicable EU harmonized standards and recommendations for achieving the basic health and safety requirements of mechanical orders. The standard plays an important role in the implementation of EU directives, and all directives are presumed to be in accordance with the provisions of the directive on the basis of the so-called "harmonization" of European standards. Harmonized standards of instruction must be published in the official European Union publication.
The European Union Standards Committee (CEN) is committed to developing an integrated version to cover three categories of European standards to support mechanical instructions. The first class (A) standard includes the general principles of various mechanical designs (e.g., EN292 mechanical design or EN 1050 risk assessment).
The second class of standards (B) covers ergonomics of specific safety devices and mechanical types (e.g., EN 418 emergency stop equipment, or EN 574 hand control).
Finally, the third class of standards (C) covers specific mechanical classifications that refer to the first two classes of standards, and focuses on specific mechanical requirements (e.g., EN201 for injection molding machines, or EN 474 for earthmoving machines). So far, most of the A and B standards have been promulgated, but about 600 technical committees and working groups are still working on the C standards, but the machinery in Annex IV is preferred. Prediction still needs years, C standard can be announced in full. At the same time, through class A and class B standards and the adoption of most general product standards, it is possible to confirm the basic requirements of the regulation. The following are the major coordination standards for mechanical instructions:

    EN, 292-1, -2: Mechanical Safety - basic concepts, general principles of design
EN 1050: Mechanical Safety - risk assessment principles
EN 60204-1: Mechanical Safety - Mechanical and electrical equipment
EN 954-1: Mechanical Safety - Safety parts of control systems
EN 294: Mechanical Safety - Safety Distance
EN 349: to prevent the smallest clearance of the human body
EN 418: Mechanical Safety - emergency shutdown
EN 1088: mechanical safety interlock
EN 775: automatic mechanism

6. mechanical and safety components of the EC type test must be carried out by the public notices
Broadly speaking, mechanical instructions divide machines into two classes: dangerous machines, ordinary machines. High submersible dangerous machinery and selected safety parts are listed in the machinery directive annex IV. Such products should have special regulations. As listed in Appendix I, the manufacturer shall include the participation of the announcement body before adding the CE mark (generally speaking, the issuing organization will issue a EC type test certificate). All other machinery shall comply with the basic health and safety requirements specified in Annex I of the directive, but the manufacturer or importer shall also carry out its conformity assessment on its own. The manufacturer shall then submit technical documentation, qualification statements and posting CE marks.
Following are the mechanical and safety components that must be tested by the public announcement for type EC testing:
A. machinery
1. single or multiple circular sawing machines for wood and similar materials or meat and similar materials
When working, the circular saw blade does not move. The circular sawing machine is made of a fixed bed with manual feeding or removable power feeding;
When working, the circular saw blade does not move, and the circular saw machine is operated by hand operated reciprocating table or bracket;
When working, the circular saw blade does not move. There is a built-in workpiece mechanical feeding device, and a circular saw machine is manually fed and (or) fed;
When working, the circular saw blade moves with a mechanical feeding device and a circular saw machine with manual feeding and / or blanking.
2. hand feeding woodworking planer;
3. hand laid woodworking planer;
4. a band saw machine with a fixed bed or moving bed (a sports car) or a movable carrier, with manual feeding and (or) blanking, for the processing of wood and similar materials or meat and similar materials;
5. combinations of machine tools for wood machine similar materials listed in articles first to 4 and seventh of this section;
6. wood processing, multi knife clamp, hand feed tenon machine;
7. vertical shaft moulding machine for wood machine similar material processing;
8. portable chain saws for woodworking;
9., the movement of stroke greater than 6mm, speed greater than 30mm/s, manual feeding and / or blanking metal cold processing press, including bending trigger;
10. a plastic injection or extrusion machine for hand feeding and / or blanking;
11. hand feeding and / or blanking rubber injection or extrusion molding machine;
The following 12. types of underground machinery: rail vehicles and machinery machine; emergency vehicles; hydraulic roof support machinery; internal combustion engine for underground working machine.
13. an artificial loader equipped with a compression device for collecting household waste;
14. as described in Annex I of 3.4.7, the protective device and the detachable rotating shaft with the universal joint;
15. reusable vehicles;
16. vertical elevation of more than 3m, there is a risk of falling lift;
17. machinery for making fireworks;
B. safety components
1. to ensure the safety of personnel and specially designed electronic sensitive device (non obscuration, sensitive parts, electromagnetic material tester etc.)
2. logic device with two hands control to ensure safety function;
3. automatic movable isolating screen for press protection, as described in part ninth, tenth and eleventh of this appendix A;
4. rollover protection device (ROPS);
5. falling debris protection devices (FOPS).
7. risk analysis and risk assessment
Under the machinery command, the manufacturer's primary responsibility is to perform risk analysis and risk assessment. The hazard analysis is to use the instrument to confirm the hazards of the machine in different life cycles and to take preventive measures when necessary. The so-called risk assessment is a series of logical actions aimed at reducing and eliminating risks. EN 1050 lists several risk assessment methods and techniques. EN 1050, along with EN954-1, describes the performance classification of components for designing safety control systems. EN954-1 not listed should use what security function, when the severity of the potential hazards based on risk assessment, position and frequency, the probability of occurrence, the designer should read the instructions, to learn how to design a safety circuit and how to select the appropriate safety parts. In accordance with the three factors listed above, the manufacturer may determine the relevant safety classifications used by the machinery.
8. mechanical instruction conformity assessment flow chart
Flow chart of mechanical instruction conformity assessment: (safety component does not attach CE mark; all machinery and its safety parts must be accompanied by EC Qualification Statement)
9. add CE mark steps
Procedures for adding CE signs to ordinary machines:
Step 1: achieve the basic safety requirements of instructions;
Step 2: prepare technical documents;
Step 3: prepare the EC qualification statement;
Step 4: apply the CE mark.
Procedures for adding CE marks to dangerous machinery:
Step 1: achieve the basic safety requirements of instructions;
Step 2: prepare technical documents;
Step 3: the announcement body participates in the completion of the conformity assessment process;
Step 4: prepare the EC qualification statement;
Step 5: apply the CE mark.
10. technical documentation (TCF)
Another responsibility of the manufacturer or its authorized representative in the European Union is the establishment of technical records. The file contains data that is mechanically consistent with instructions. Within ten years from the date of mechanical production, the technical archives shall be readily available for inspection by the national market supervision and control units at any time. The technical documentation shall contain relevant design, construction, risk assessment and compliance validation documents (e.g. test data), and related manuals. The number of pages of technical records depends on the nature of the machinery and the chosen means of compliance (e.g., the use of proven engineering practices rather than harmonized standards).
The contents of technical documents shall normally include product design, manufacture and use:

 Mode code   

 Modifications to the basic schema     

 What is added to the basic schema contrast?

 Mode A

 Internal production control

It involves design stage and production stage. The model does not require the participation of the announcement body and is carried out by the manufacturer himself.

ModeB

EC type test

Design phase. The recognized institution (the announcement body) confirms and proves that the sample of the product meets the requirements of the corresponding instruction, and the issuing institution issues the EC type certificate. The model must be used in combination with other modes of conformity assessment at the production stage.

 ModeC

 Conformity statement

Design production phase, after model B. The model does not require the participation of the public notice and the manufacturer warrants that the product is in conformity with the type described in the "EC type test certificate".

ModeD

 Production quality assurance

Involves the production phase, after the model B. The model is based on the quality management system standard EN ISO 9002, and the announcement body is responsible for approving and controlling the manufacturer's production, product final inspection and testing quality management system.

 ModeE

 Product quality assurance

Involves the production phase, after the model B. The model is based on the quality management system standard EN ISO 9003, and the announcement body is responsible for approving and controlling the manufacturer's production, product final inspection and testing quality management system.

 ModeF

Product verification

Design production phase, after model B. The announcement body is responsible for controlling the conformity of the type product described in the EC type test certificate and Issuing the certificate of conformity.

 ModeG

EC single room authentication

Involving design and production phases. Each product is inspected by the public notice organ and issued a certificate of conformity.

 ModeH

 Total quality assurance

Involving design and production phases. The model is based on the quality management system standard EN ISO 9001, and the announcement body is responsible for approving and controlling the manufacturer's design and production. Product final inspection and test quality management system。

    The description of products; design principle, pattern (including general layout, parts diagram, circuit diagram etc.); understand the drawings, charts and products needed; all or part of the list using the standard; do not adopt the standard, to meet the basic requirements specified in the directive measures plan and design calculation; the test results and test report.

11. mechanical equipment related instructions
According to the mechanical instruction, if the machinery is added with the CE mark, it indicates that the machine not only meets the requirements of the mechanical instruction, but also meets the requirements of the relevant and should comply instruction. In other words, mechanical products in conformity assessment, not only to comply with mechanical instructions, but also to follow the other instructions related to it. These instructions can be used to reinforce instructions, such as EMC instructions (89/336/EC), or low voltage instructions (73/23/EC) that overlap with mechanical instructions. In order to comply with the relevant EU directives, machinery manufacturers should consider the following four EU directives:
The elevator directive (95/16/EC) covers new elevators that are permanently installed in buildings and buildings for manned or freight lifts. This instruction shall also apply to certain safety parts listed in Appendix IV of the elevator instructions. The directive does not cover lifts temporarily installed on the site, or machinery mounted hoists, and lifts for use only in mechanical orders.
Noise instruction (2000/14/EC) to regulate the noise value of outdoor equipment in the environment. This directive covers 57 outdoor equipment, which is divided into two categories. A class is listed in the twelfth chapter on noise limits. The other is listed in the thirteenth chapter and applies only to noise markers. Equipment for use in the 57 chambers of the equipment, 22 of which are listed in the twelfth chapter. In this type of equipment, the manufacturer has the obligation to comply with a particular sound pressure value. These values shall be evaluated and confirmed by the designated verification authority.
The ATEX directive (94/9/EC) applies to potentially explosive equipment and protection systems and has been implemented since July 1, 2003. The project's ATEX directive replaces the original three OLD APPROACH instructions, namely, 76/117/EEC and 82/130/EEC.
Product safety directive (92/59/EEC) contains the general definition of security products, "said use and use of any product in the applicable conditions of normal or reasonably foreseeable period, the lowest risk does not appear any risk or the use of the product is deemed acceptable and the personnel safety and health protection has a high degree of consistency. This directive specifies the safety of consumer products within the EU, but does not contain industrial applications.
12., plus CE sign responsible person
If our products are to be put into the EU market and sold and put into use in the EU market, these products will be imported from third countries to the European union. If these products belong to the scope of the New Approach Directives covered so, whether they are new products or old products, must be based on the new method of instruction to the design, manufacturing and quality assessment (if necessary, also need the participation of the third party conformity assessment). Products entering the EU market and delivery, will also be subject to customs, market supervision agencies inspection. In this process, the manufacturer will design the authorized agent of the manufacturer or the manufacturer in the European Union
Put the product into the EU market importers, third parties involved in product quality assessment, etc., then, in this process, they should bear any responsibility?
Manufacturer: as stipulated in the European Union, if a third country manufacturer wants to put its product on the European Union market and deliver it, the manufacturer shall be responsible for the same responsibility as the manufacturer of the member countries that have imported the product. Here refers to the manufacturer for its own interests, on behalf of their own design, manufacture products, and the products to the EU market of natural person or legal person, including those in the name of the manufacturer assembly, packaging, processing products or natural or legal persons applying their own label on the market in the pre goods. In addition, manufacturers include people who change their original use, performance, or update the product (or produce another product on the basis of it) and put it on the market. Manufacturers, whether they design their own products or manufacture their own products or put their products on the market in their own name, are solely responsible for whether their products meet the requirements of the relevant new methods. What are the responsibilities of the manufacturer?
1) design and manufacture products in accordance with the basic requirements of the relevant product instructions;
2) conformity assessment of the product in accordance with the relevant instructions of the product.
Authorized agent: the manufacturer may employ an authorized agent in the European Union to perform certain tasks required by the relevant instructions on behalf of his own interests. In accordance with the requirements of the new method of instruction, these agents must be stationed in the European Union (holding the passport of the member states of the European Union), the agent can exercise the rights of the manufacturer. The task of the authorized agent determined by the manufacturer must be clear, and a written authorization shall be established in writing, in particular, the content of the task and the authority of the agency shall be clearly defined. According to the relevant instructions and procedures for assessment of conformity requirements, delegated permissions should include; ensure and declaration of conformity to product requirements; CE mark for product identification code and announcement of the organization; the drafting and signing the EC declaration of conformity; custody of the EC declaration of conformity and related technical documentation for the national market supervision and inspection institutions. The above-mentioned duties of the authorized agent are actually directed at the member state of the authorized agent, not for the manufacturer. In accordance with the directive, the manufacturer said that the authorized agent's behalf, whose behalf was in the interests of the company, was of a management nature and that the manufacturer was responsible for the act of the authorized agent to which it was established.
The importer (the person in charge of products on the market): if the manufacturer is not in the EU, the EU has not authorized agent, according to the provisions of the new order, the importer (the person in charge of products on the market) must provide the necessary information for the product market supervision mechanism, such as a copy of the EC declaration of conformity and the relevant technical documents. Therefore, the importer shall require the manufacturer to issue a formal written guarantee that the relevant documents are available at the time of the inspection by the market supervision institution. Importers should establish regular contact with manufacturers.
"Third party": means that the new method instruction states that it is qualified to undertake the task of conformity assessment, rather than the general certification body. Notice the mission is stipulated according to the instruction of the manufacturer or its authorized agent identified in the EU to provide conformity assessment services to apply for certification of the quality management system or the products tested, and prove that it meets the requirements. According to the directive, the announcement institutions involved in the conformity assessment procedures are different, tasks and responsibilities are different: it may be a prototype test, may also be inspection, factory product quality is also possible with EN ISO 9000 series of standards based management system.
To sum up, the manufacturer is the sole and ultimate responsible person for the product in line with the requirements of the new method instruction. The manufacturer's authorized agent in the European Union only acts on behalf of its interests, but does not assume final responsibility. In general, importers are manufacturers' contacts in the European union. And the announcement organization only proves whether the manufacturer's product or quality management system meets the requirements.
13. conformity assessment model
Conformity assessment is subdivided into 8 basic models and 8 derived models, which relate to the design phase and / or production phase of the product. Conformity assessment may be made by the first party (manufacturer) and / or the third party (the announcement body). Some patterns are determined on the basis of the EN ISO 9000 series standards.


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