1. New machinery
  2. General info
  3. Conformity assessment procedures

A. Dąbrowski

Characteristics of conformity assessment procedures as per Directive 2006/42 / EC and rules for the application of the RfU of the Notified Body for Machinery.


 

Table of contents

1. Introduction. 3

2. Definitions. 5

3. Obligations of the manufacturer or his authorized representative. 7

4. The content of the technical documentation prepared by the manufacturer. 8

5. Machine marking. 9

6. Operating instructions for the machine. 10

7. EC Declaration of Conformity.. 12

8. Procedures for conformity assessment of machines. 13

9. Marking â € žCEâ € ?? machinery. 17

10. The use of harmonized standards in the assessment of conformity of machines with the essential requirements of occupational health and safety. 18

11. Compatibility assessment for a non-finished machine 19

12. Rules for the application of the RfU of the Organization of Notified Bodies for Machinery. 22

13. Bibliography. 27

 

 

1. Introduction

The European Directives of the New and Global Approach (the so-called economic directives) concern the liability of producers who place on the market or put into service products subject to these directives. Examples of the above Directives are given in Table 1.

Table 1. Selected EU economic directives

Directive

number

symbol

subject

2006/42 / EC

MD

machines and security elements

2006/95 / EC

LVD

low voltage electrical equipment

2004/108 / EC

EMC

energy compatibility

87/404 / EEC

90/488 / EEC

93/68 / EEC

SPV

simple pressure tanks

94/9 / EC

ATEX

equipment
used
in potentially
explosive atmospheres

2000/14 / EC

NOISE

noise emission in the environment by equipment intended for outdoor use

Typically, products powered by electricity should comply with the requirements of the Low Voltage Directive (LVD). However, this practice has changed in the case of machines and it has been recognized that their electrical safety is ensured when the requirements of the Machinery Directive are met. Typically, machines should also comply with the Machinery Directive, other directives that apply to them. A wood circular saw that can also be used on open ground should meet the requirements of the directives (Table 1): MAD, NOISE, EMC and the painting booth: MAD
and ATEX.

Adopt by The European Parliament and the Council of the European Union on 17 May 2006, Directive 2006/42 / EC [1] on machinery, aimed to: allow free movement of machinery within the internal market and harmonization at EU requirements for health and safety in the design and construction of machines. An obligation imposed on Member States to ensure the proper application, as set out in that Directive, of requirements for the protection of the health and safety of persons. Machinery Directive 2006/42 / EC specifies the essential safety requirements for machines placed on the European Union market in the strict (basic) sense, as well as for interchangeable equipment, safety components, accessories here for lifting, chains, ropes and belts, detachable devices for mechanical power transmission and for unfinished machines. At the same time, it imposes on the manufacturers of these products the responsibility to ensure the safety of their use. Responsibility may also be imposed on other entities participating in the supply chain of these products - ie authorized representatives of producers, importers or distributors. Every machine that is placed on the market in the European Union must meet the essential safety requirements. This means that it must comply with the relevant requirements of the Directive. ABOUT Responsibility may also be imposed on other entities participating in the supply chain of these products - ie authorized representatives of producers, importers or distributors. Any machine that is placed on the market in the European Union must meet the essential safety requirements. This means that it must comply with the relevant requirements of the Directive. ABOUT Responsibility may also be imposed on other entities participating in the supply chain of these products - ie authorized representatives of producers, importers or distributors. Every machine that is placed on the market in the European Union must meet the essential safety requirements. This means that it must comply with the relevant requirements of the Directive. ABOUTthe price of compliance with the directive is therefore an action to show that a given machine, device or other product or manufacturing process is in compliance with the essential requirements set out in that directive. In order for manufacturers to comply with the essential requirements, they must:

  • identify relevant directives,
  • identify the relevant harmonized standards
  • use C-type standards in the machine design process (using, on their basis, the presumption of conformity of the machine with the essential requirements of the directive) or essential requirements (taking into account own solutions or specified in other standards)
  • check (whether alone or with the participation of a notified body) compliance with the essential requirements
  • document the conformity of the machine by collecting appropriate technical and construction documentation
  • prepare a declaration of EC conformity
  • place the CE marking on the machine
  • provide the instruction manual, together with the declaration of conformity, to the user

2. Definitions

In connection with the conformity assessment process according to Directive 2006/42 / EC, the basic deadlines listed below apply.

Authorization - qualification by the minister or head of the central office, due to the subject of conformity assessment, of the reporting unit or laboratory to the notification process [2].

Certification - operation of a certification body that demonstrates that a duly identified product or manufacturing process is in compliance with the essential or specific requirements [2].

Certificate of conformity - a document issued by a notified certification body confirming that the product and the manufacturing process comply with the essential requirements [2].

Declaration of conformity - declaration of the manufacturer or his authorized representative, stating on his exclusive responsibility that the product complies with the essential requirements [2].

New Approach Directives - European Community Directives, adopted in accordance with the principles contained in the Resolution of the Council of the European Union of May 7, 1985, on a new approach to technical harmonization and standardization [2].

Certification body - a unit independent of the manufacturer, its authorized representative or importer, who certifies [2].

Machine [1]

(a) a      team, equipped or intended to be equipped
with a drive mechanism other than directly using the force of human or animal muscles, consisting of fused Or elements, at least one of which is mobile, connected in a whole with a specific application

b) the      team referred to in point (a), without elements intended for its connection at the workplace or for connection to sources of energy and power

c) the       team referred to in points a) and b), ready to be installed and able to function only after being mounted on means of transport or installed in a building or on a structure

d)      assemblies of machines referred to in items a) - c), or incomplete machines that have been set up and controlled in order to achieve a specific end effect such a way that they work as an integrated whole

(e) a set of      coupled parts or components, of which at least one is movable, connected in full, intended for lifting loads whose sole source of power is directly > Average use of the strength of human muscles.

Completed machine - a unit that is almost a machine, but can not serve a specific application by itself. The drive system is an incomplete machine. The sole purpose of an incomplete machine is to connect to or join another machine or other non-ending machine or equipment, thus creating a machine to which Directive 2006 applies / 42 / WE [1]

Safety element - an element that serves to fulfill the safety function and which is placed on the market separately, and whose damage or malfunction threatens the safety of persons, and is not necessary the machine can be run or it can be replaced with ordinary elements so that the working equipment can work. These are, therefore, all kinds of protective shields and protective devices placed on the market or used independently, i.e. not together with the machine. An indicative list of safety components is given in Annex V to Directive 2006/42 / EC [1]

Machine manufacturer - a natural or legal person who designs or manufactures infinite machines or machines covered by the Directive and is responsible for the conformity of a machine or machine not fully compliant with Directive 2006/42 / EC, with note its placing on the market, under its own name or trademark or for your own use. In the absence of a manufacturer corresponding to the above definition, the manufacturer is considered a natural or legal person who places on the market or puts into service an incomplete machine or machinery covered by Directive 2006/42 / EC [1].

Authorized representative - a natural or legal person or an organizational unit without legal personality having its registered office in the territory of a Member State of the European Union or a Member State of the European Free Trade Agreement (EFTA) - parties to the agreement on the European Economic Area, authorized by the producer in writing to act on his behalf [2].

Notification - notification to the European Commission and the EU Member States of the certification and controlling bodies as well as authorized laboratories competent to perform the activities specified in the conformity assessment procedures [2] .

Harmonized standards - European standards developed and approved by European standardization organizations on the basis of a mandate given by the European Commission, the numbers and titles of which have been published in the Official Journal of the European Union [2].

Putting into use - the first in the territory of the European Union member state or the EFTA member state - parties to the European Economic Area Agreement, the intended use of a product that has not been placed on the market [2 ].

Conformity marking - marking confirming the conformity of the product with the essential requirements [2].

Marketing - made available by the manufacturer, his authorized representative or importer, free of charge or for a fee, for the first time in the territory of a Member State of the European Union or a Member State of the European Union Free Trade Agreements (EFTA) - parties to the Agreement on the European Economic Area, a product for the purpose of its use or distribution [2].

Essential requirements - requirements in terms of product characteristics, its design or manufacture, specified in the new approach directives [2].

Safety mark - a sign created by a combination of a geometric shape, a hue and a graphic or pictorial symbol (pictogram) or text, conveying specific information related to security or its threat [ 3].

3. Obligations of the manufacturer or his authorized representative

In accordance with the requirements of Directive 2006/42 / EC, the manufacturer or his authorized representative should ensure and document the conformity of the machine with its essential requirements.

Before placing the machine on the market or putting it into use, it has:

·            Ensure that it meets the relevant essential requirements in terms of safety and health. To this end, it is to ensure that in the design process of the machine (taking into account the adopted limitations, its parameters and the division of tasks between the machine and its operator), all threats and essential requirements posed in the aforementioned legal acts, the use of which will ensure sufficient risk reduction

·            Ensure that technical documentation is available (Annex VII to the Directive)

·            Provide the necessary information, in particular the machine instruction (Annex 1, point 1.7.4 of the Directive)

·            Carry out proper conformity assessment procedures (Annex VIII, IX and X of the Directive)

·            Draw up the EC declaration of conformity and ensure that it is attached to the machine (Annex II of the Directive)

·            Place the CE marking on the machine (Annex III of the Directive).

The manufacturer or his authorized representative should ensure that a machinery meeting the provisions of Directive 2006/42 / EC and other related directives of the new approach is provided, together with:

· A            declaration of conformity according to the range provided earlier

·            Full marking (including CE) according to the previously specified requirements

·            Operating instructions (DTR) according to the previously specified requirements

·            Basic special equipment and equipment that allows it to be adjusted, maintained and used without creating hazards.

4. The content of the technical documentation prepared by the manufacturer

The producer should collect the documentation of the machines produced, containing in accordance with And it's done. VII to Directive [1]:

â € ¢ general machine description

â € ¢ assembly drawing together with control circuit diagrams

â € ¢ detailed drawings of elements affecting the security and health protection together with the attached calculations and results of tests (measurements, analyzes, checks, etc.), necessary to check the conformity of the machine with the essential requirements in the field of safety and health protection

• risk assessment documentation containing:

- a list of the essential safety and health requirements applied when designing the machine

- a description of the measures used to eliminate the identified hazards posed by the machine or to reduce the risk and indicate residual risks associated with the machine

â € ¢ A list of applicable technical standards and specifications (requirements)

â € ¢ a copy of the machine's instructions

â € ¢ reports (reports) containing the results of all surveys

â € ¢ other technical reports, certificates and approvals provided by competent units or laboratories and required certificates of material and component suppliers

â € ¢ declaration of incorporation of a fixed unfinished machine with appropriate assembly instructions - if applicable

â € ¢ a copy of the EC declaration of conformity for machines or other products incorporated into the machine - if applicable

â € ¢ copy of the EC declaration of conformity

â € ¢ in the case of serial production: a description of the steps taken to ensure that the machine remains in compliance with the essential safety and health requirements;

This documentation should be kept for 10 years from the end of machine production.

5. Machine marking

All machines should be marked in a visible, legible and durable manner. It should, in accordance with point 1.7.3. I to Directive [1], contain at least:

â € ¢ the name and full address of the manufacturer and his authorized representative (if any)

â € ¢ defining the machine (usually the name of the machine, it is recommended to comply with the harmonized standard)

â € ¢ CE marking

â € ¢ designation of a series or type of machine

â € ¢ serial number (if there is one),

â € ¢ year of machine construction understood as the year of completion of its production:

- the production process is completed in the manufacturer's factory at the latest when the machine leaves the plant for delivery to the importer, distributor or user

- in the case of final assembly at the user, this process ends at the moment of assembly completion and readiness to work (anti-or post-loading is prohibited)

â € ¢ designation of machines intended for use in potentially explosive atmospheres

â € ¢ complete information on the type of machine and necessary to ensure safety of use (eg: maximum speed of rotating components, maximum diameter of the tools used, machine weight and its parts carried during use by lifting devices, additional information given in points 3.6.2, 4.3.2, 4.3.3 and 6.5 of Annex I to Directive [1]).

6. Operating instructions for the machine

The requirements for the operating instructions for all machines are included in point. 1.7.4. Zaa,. And to the Directive [1]. The manual should contain:

· The name and full address of the manufacturer or his authorized representative

· Data included in the label, excluding the serial number

· EC Declaration of Conformity or a document presenting its content,

· General description of the machine

· Drawings, diagrams, descriptions and explanations necessary for the use, maintenance and repair of the machine and checking the correctness of its operation

· Description of the position or work positions that operators can occupy

· Description of the intended use

· Warnings regarding unauthorized use

· Instructions for assembly, installation and connection, including drawings, diagrams

· Information on installation and assembly to reduce noise or vibrations

· Information on commissioning and operation and, if necessary, instructions on operator training

· Information on existing risk (residual)

· Information on protective measures that must be applied by the user in appropriate cases, including the delivery of personal protective equipment

· Basic characteristics of the tools used

· Conditions in which the machine meets the requirements of stability during use, transport, assembly, stopping, testing and anticipated failures

· Information specifying safe conditions of transport, handling and storage with the mass of the machine and the weight of its parts, if they are to be transported separately

· How to proceed in case of accident or breakdown; if a blocking function has been used in the machine, methods for safe unlocking must be given

· Description of regulatory and maintenance activities to be performed by the user and preventive maintenance measures (a list of regularly checked items and parts, inspection intervals, inspection equipment, replacement or repair criteria, and safety conditions during the exchange, as well as access to exceptional repairs)

· Instructions to ensure the safety of adjustment and maintenance, including protective measures to be taken in the course of these activities

· Specifications of spare parts to be used if they affect the health and safety of operators

· Information on the noise emitted and data on actual values ​​given below the parameters determined as a result of measurements made on a given machine or technically comparable:

- equivalent sound pressure level at the workplace, corrected by the A characteristic, when it exceeds 70 dB (A). If the sound level does not exceed 70 dB (A), it must be confirmed in the instructions

- peak instantaneous sound pressure level at workplaces, corrected by the C-curve, when it exceeds 63 Pa (130 dB) in relation to 20 Pa

- the sound power level of the machine, where the equivalent sound pressure level at workplaces, corrected by the A-characteristic, exceeds 80 dB (A).

For individual machine groups, the information provided in point. 2.2.1.1, 2.2.2.2, 3.6.3, 4.4 add. 1 of the Directive [1].

The instructions should be drawn up in at least one of the 23 official languages ​​of the EU Member States and have the inscription "Original instructions" ?? (in the language of the version)

on versions or language versions verified by the manufacturer or an authorized representative. If such instructions do not exist in the official language or languages ​​of the Member State in which the machine will be used, the translation into that language or languages ​​should be provided by the manufacturer or its authorized representative representative or by the person bringing this machine into the language area concerned. This instruction should have the inscription "Translation of the original instruction". Equipment of the machine being placed on the market or put into service in "Original installation" and (if applicable) in the "Translation of the original manual", it allows the user to check its formulations when in doubt.

7. EC Declaration of Conformity

The Declaration of Conformity is issued by the manufacturer or his authorized representative in languages ​​identical to the instructions for use. Must be attached to the machine before placing it on the market or putting it into service.

This declaration according to point And it's done. II to Directive [1] contains:

· The name and full address of the manufacturer or authorized representative

· Name and address of a person residing in the EU, authorized to prepare technical documentation (natural or legal person, based in the EU, which the manufacturer entrusted with the task of completing and making available the relevant elements of technical documentation in response to the request of the market surveillance authority of one of the Member States). Please note that this person is not responsible for designing, making and assessing the conformity of the machine, applying the CE marking or issuing a declaration of conformity. Every machine manufacturer must point to this person:

- in the case of a producer established in the Community, such a person may be the producer himself, an authorized representative, a contact person among staff (eg signing a declaration of conformity or another natural or legal person whose the manufacturer has entrusted this task)

- in the case of a producer from outside the Community, it may be any natural or legal person entrusted by the manufacturer with this task, as well as an authorized representative - irrespective of other tasks

· Full identification of the machine ( machine data should be as marked on the machine, but in full version):

- the machine must be clearly identified and the principle is to give the serial number,

- for machines produced in large series, you can issue one declaration of conformity for the entire series or batch, but then you must give the scope covered by the declaration or issue declarations for each of these machines

· Statement that the machine ensures compliance with the machinery directive and other related directives

· Name and identification number of the notified body that has approved the full quality assurance system

· The name and identification number of the notified body that carried out the EC type examination and the number of the EC type-examination certificate

· Compliance with harmonized and other standards, if used in the conformity assessment process (it is assumed that the indicated standards have been applied in full, otherwise unapplied provisions should be given)

· Name, surname and signature of the authorized person

· Place and date of preparation.

8. Procedures for conformity assessment of machines

In order to assess the conformity of machines with the essential requirements of the Machinery Directive [1], procedures have been established to distinguish between machines that have been caught and not worn. IV to the Directive [1]. For machinery not mentioned in the annex, the manufacturer or his authorized representative uses the conformity assessment procedure connected with the internal control of machine production provided for in the annex. VIII to the Directive [1].

The second group are machines included in Annex IV of the Directive, which may be assessed by the manufacturer himself or in special cases (eg the lack of a harmonized or total standard or a part of the assessment of conformity with the essential requirements). Inconsistency of the machine with such a standard) manufacturer with the participation of a notified body.According to Annex IV, the categories of machines to which one of the conformity assessment procedures applies is circular saws for cutting wood or meat and similar materials, planer planers and planers woodworking thicknessers, machines for underground locomotives and brake carts and hydraulic powered roof supports, lifts for servicing vehicles, equipment for lifting persons or persons and goods, posing a risk of falling from a height greater than 3 m, portable assembly machines and other impact machines activated by means of cartridges, protective devices designed to detect the presence of persons .

The conformity assessment procedures that must be carried out by machinery manufacturers listed in Annex IV have particular importance for ensuring machine safety. In particular, it is necessary to pay attention to these procedures, which must be carried out with the participation of a notified body - i.e. EC type examination (according to Annex IX) and the full quality assurance procedure > (Provided for in Annex X). INall machines are subject to the so-called conformity assessment. The conformity assessment may be combined with internal control at the machine execution stage, it may be an EC type examination (examination of a specific type of machine by the authorized entity) or so-called full quality assurance (when the notified body assesses and approves the quality system of the machine manufacturer and monitors its use).

The conformity assessment combined with the internal control at the machine design stage is the procedure according to which the manufacturer (or his authorized representative) ensures and declares that the machine meets the essential requirements. The producer must carry out, among others appropriate tests and trials of component parts, accessories or ready-made machines to determine whether their design or construction allows safe assembly and putting the machine into service. Reports and results of these tests are included in the technical documentation.
The technical documentation should be available for a period of at least 10 years from the date of manufacture of the machine, and in the case of serial production - from the date of manufacture of the last copy.

EC type examination is the procedure according to which the notified body examines, states and certifies that a representative model of the machine ("type"), fulfills the essential requirements. EC type examination by a notified body follows the application of the manufacturer, who encloses the technical documentation and a copy of the machine whose type will be examined by the notified body. If the test shows that the machine type meets the essential requirements, the notified body issues the "EC type examination certificate" to the applicant. The manufacturer and the notified body are required to keep a copy of this certificate, technical documentation and all relevant documents for 15 years from the date of issue of the certificate. The manufacturer is obliged to inform the notified body of any changes to the approved type and observe that the produced machine is in accordance with the current state of technical knowledge. Therefore, EC type-examination is the procedure according to which the notified body examines, states and certifies that a representative model of the machine meets the essential requirements.

Full quality assurance is the procedure by which the notified body assesses and approves the quality system of the machinery manufacturer referred to in Annex IV to the Directive [1] and monitors its application. The manufacturer must have an approved quality system, subject to supervision, for design, manufacture, final inspection and testing, as required. On the basis of the certificate held, the manufacturer provides the buyer with a written declaration of conformity. In the declaration, the manufacturer provides and declares that the machine corresponds to the type described in the EC type examination procedure. In confirmation of this manufacturer, he additionally marks the machine with the CE conformity mark. Figure 1 presents the procedures for assessing EC conformity of machines according to Directive 2006/42 / EC.When choosing assessment procedures, one should be guided by both the principles discussed and the competencies of the personnel. The manufacturer may always, at his own discretion, apply to an external unit, preferably notified in the relevant area of ​​the Machinery Directive, for testing and evaluation, or only for consultation .

Figure 1. Procedures for assessing EC conformity of machines according to Directive 2006/42 / EC

9. Marking â € žCEâ € ?? machinery

By affixing the CE marking to the machine, the manufacturer declares compliance with all applicable directives. In other words, the CE marking is a visual signal to the buyer and the relevant authorities that it has been designed, manufactured and tested to meet the requirements of the directives and that there is a person responsible for placing the machine on the market . The CE marking may not be affixed to the product before completion of the conformity assessment procedure and verification of product conformity with all provisions of the relevant directives.The affixing of the CE marking confirms on its own responsibility that the machine meets the provisions of European Union directives, including the machinery directive. When affixing the CE marking, the following rules (specified in Annex III of Directive 2006/42 / EC) must be met:

  • the CE marking consists of letters in graphic design and keeping the proportions given in Annex III
  • the marking should not be less than 5 mm (for machines of small size, a distance is allowed)
  • the marking should be placed in the immediate vicinity of the name of the manufacturer or his authorized representative, using the same printing technique
  • in the case of a full quality assurance procedure, the CE marking must be affixed with the identification number of the notified body

The product can not be marked with the CE symbol if it is not covered by a directive requiring the affixing of such a mark. The obligation to affix the CE marking applies to all products that are covered by directives providing for such marking and that are to be placed on the Union market. This also applies to products that are being put into use in this market for the first time. The CE mark must be placed on:

  • all new products manufactured in Member States or third countries,
  • all products used and products from the second hand imported from third countries
  • significantly modified products subject to directives as new products.

A manufacturer based in or outside the EU is the person ultimately responsible for the conformity of the product with the provisions of the directive and for affixing the CE marking. To implement this commitment, the manufacturer may designate a representative (authorized) representative established in the Community.

The CE mark can not be removed from the product without leaving marks visible under normal conditions. However, this does not mean that the CE marking must be an integral part of the product. The CE marking and the identification number of the notified body may not necessarily be affixed to an article within the EU. For example, a marking operation may take place in the third country, if the product has been manufactured therein and the notified body applied the conformity assessment procedure there according to the provisions of the directive.

10. The use of harmonized standards in the assessment of conformity of machines with the essential requirements of occupational health and safety

European harmonized standards are standards that have been developed at the request of the European Commission by the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC) or the European Telecommunications Standards Institute (ETSI), and their content has been a determined on the basis of requirements approved by the European Commission. Harmonized standards are adopted in accordance with CEN / CENELEC / ETSI regulations and are officially transmitted to the Commission after approval. The recommended and easiest way to demonstrate conformity with the Directive is to demonstrate compliance with the relevant harmonized standards. The health and safety requirements in these legal acts are quite general. Therefore, according to the so-called the new approach, detailed technical requirements are recognized in the European harmonized standards. In Poland, their lists are included in the announcements of the President of the Polish Committee for Standardization, published in the Polish Monitor, as well as on the websites of PKN. Ensuring compliance with the requirements of the harmonized standards for the particular machine is considered as a presumption of fulfillment of its essential requirements, if these standards cover the whole, relating to a given machine, the scope of the requirements In the directives. Harmonized standards, although not obligatory, are most often used to demonstrate conformity of machines with essential requirements. This does not exclude the possibility of demonstrating this conformity in a different way, which must ensure an even worse level of security. European standards for the safety and ergonomics of machines are divided into:

â € ¢ Type A norms - including basic terms, design principles and general aspects applicable to all machines (eg PN-EN ISO 12100)

â € ¢ Type B standards - thematic, regarding one aspect of safety or one type of protective equipment that can be used in many different machines.

Stand out:

- type B1 standards - for specific security aspects (eg distance

security - PN-EN ISO 13857, PN-EN 349, PN-EN 999)

- B2 type standards - for protective devices (eg two-hand control devices - PN-EN 574, blocking devices - PN-EN 1088, Pressure sensitive - PN-EN 1760-1, 2 and 3, shield - PN-EN 953)

- C-type norms - standards containing detailed safety requirements for a specific machine or a narrow group of machines (eg PN-EN 1870 standard for circular saws consists of from 17 parts considering different construction solutions of these machines).

11. Compatibility assessment for a non-finished machine

Before placing a spare-paper machine on the market, the manufacturer or his authorized representative shall ensure that the procedures for ensuring compliance with the essential requirements have been completed. The manufacturer or his authorized representative may place the machine on the market in a child-less condition, provided that he makes a declaration of incorporation (stating that the unfinished machine is intended to be another machine or assembling with another machine incomplete to create a machine). Before placing a child on the market, the manufacturer or his authorized representative shall ensure:

  • development of appropriate technical documentation for the infinite machine, in accordance with Annex VII B of the Directive [1]
  • preparation of assembly instructions in accordance with Annex VI of the Directive [1]
  • drafting the declaration of incorporation in accordance with Annex II B of the Directive [1].

The procedure for assessing the EC conformity of a machine which is not completed in accordance with Directive 2006/42 / EC is shown in Figure 2.

 

Figure 2. EC conformity assessment procedure for the machine not compliant with Directive 2006/42 / EC

Instructions for assembling an incomplete machine should include a description of the conditions to be met in order to properly incorporate it into the final machine, so as not to pose a threat to health and safety. The assembly instructions should be written in an official EU language approved by the manufacturer of the final machine or by his authorized representative. The assembly instructions and the declaration of incorporation remain attached to the incomplete machine until they are included in the final machine and are then part of the machine's technical documentation. The technical documentation for the machine should meet the following requirements:

  • it should indicate which regulatory requirements are applied and fulfilled.
  • it should cover the design, manufacture and operation of the incomplete machine to the extent necessary to assess compliance with the essential health and safety requirements applied.
  • it should be prepared in at least one of the official languages ​​of the European Union.
  • it should include a construction documentation containing:

- assembly drawing of an incomplete machine with control circuit diagrams

- detailed drawings, including attached calculations, test results, certificates, etc., necessary to check the conformity of an incomplete machine with the essential health and safety requirements applied

- risk assessment documentation presenting:

· The          applied procedure, including: a list of applied and fulfilled essential requirements in the scope of health and safety protection,

·          Description of preventive measures implemented to eliminate identified hazards or reduce risks and indicate residual risk, if applicable,

·          Applied standards and other technical specifications, indicating the essential health and safety requirements covered by these standards,

- all technical reports giving the results of all tests carried out by the manufacturer or by an entity chosen by the manufacturer or his authorized representative,

- a copy of the instructions for assembling the incomplete machine.

- in the case of series production, the inter-planting measures to be taken to ensure that the incomplete machine complies with the essential health and safety requirements applied.

The manufacturer should carry out appropriate tests and attempts at component parts, fittings or incomplete machines to determine whether their design or construction allows for safe assembly and use. Relevant reports and results are included in the technical documentation. The technical documentation should be available for a period of at least 10 years from the date of manufacture of the incomplete machine or, in the case of serial production, from the date of manufacture of the last copy and on request submitted to the market surveillance authorities. Technical documentation does not have to be in the territory of the European Union Member State and does not have to be permanently available in material form. It should be possible to complete it and submit it to the market surveillance authorities by the person designated in the declaration of incorporation.

12. Rules for the application of the RfU of the Organization of Notified Bodies for Machinery

Notified bodies take part in conformity assessment processes as "expert experts", mainly in "difficult cases", i.e. in the case of the above-mentioned entities. machinery listed in Annex IV of the Directive for which no harmonized standards have been established or where the machinery is partly or totally incompatible with such standards. The unification and assurance of appropriate quality of practical activities carried out in this field by various notified bodies operating in the European Union is of particular importance. On the one hand, the aim is to ensure impartial and equal treatment of producers, and on the other hand to ensure the same high level of safety introduced on the market of machinery, confirmed by notified bodies in issued certificates. Notified bodies take part in conformity assessment processes as "expert experts", mainly in "difficult cases", i.e. in the case of the above-mentioned entities. machinery listed in Annex IV of the Directive for which no harmonized standards have been established or where the machinery is partly or totally incompatible with such standards. The unification and assurance of appropriate quality of practical activities carried out in this field by various notified bodies operating in the European Union is of particular importance. On the one hand, the aim is to ensure impartial and equal treatment of producers, and on the other hand to ensure the same high level of safety introduced on the market of machinery, confirmed by notified bodies in issued certificates. The exchange of experience between notified bodies is organized as part of the European coordination of notified bodies for machinery (NB-M). The goal of NB-M is to discuss problems arising during the conformity assessment procedures and to harmonize the practice of notified bodies. Participation in coordination activities is one of the criteria for notification of an individual. The European coordination of notified bodies in the area of ​​the Machinery Directive 2006/42 / EC is divided into a series of so-called Vertical Groups dealing with various categories of machines listed in Annex IV (currently there are 12 such groups). As part of the European coordination of notified bodies in the area of ​​the Machinery Directive (designation NB-M in Fig. 1), there is a Horizontal Committee, which oversees and coordinates the work of these Vertical Groups and deals with issues related to the activity of all notified bodies [4]. The European Commission supports the functioning of NB-M, financing the technical secretariat, which prepares the work of the Horizontal Committee, as well as the administrative secretariat, which organizes meetings and manages the flow of documents. NB-M accepts the so-called "Recommendations for use", which contain agreed answers to questions discussed within the Vertical Groups. In principle, these recommendations are issued if there is no relevant harmonized standard or if the relevant harmonized standard does not provide a sufficiently detailed answer to some of the questions. In the event of the adoption of the relevant harmonized standard or the corresponding amendment of the harmonized standard, recommendations shall be withdrawn. "Recommendations for use" ?? adopt the NB-M Horizontal Committee, which then presents them to the Working Group on Machinery for approval. Recommendations approved by the Working Group on Machinery are published on the Commission's website - EUROPA. considered as an important reference source ensuring the uniform application of the Machinery Directive by notified bodies. Meetings of the Horizontal Committee take place periodically (most often twice a year) with the participation of delegates representing notified bodies of the EU member states and the countries of the European Economic Zone (EEA). In addition, the Chair of Vertical Groups and other invited participants appearing as observers are present at KH meetings, e.g. members of the standardization committees (CEN, CENELEC), government representatives from individual member states take part participating in the work of the Committee on Machinery, representatives of the European Confederation of Trade Unions and representatives of notified bodies from countries applying for membership in the European Union. Bearing in mind that the directive specifies "only" ?? essential requirements in the field of health and safety of common use (supplemented by a number of more detailed requirements for certain categories of machines) harmonized standards are being developed to help manufacturers prove compliance with these requirements essential and to enable this compliance to be monitored. In this context, the Horizontal Committee also cooperates with standardization committees, providing them with their comments on standards harmonized with Directive 2006/42 / EC (ie those in which they are included) That the directive defines "only" ?? essential requirements in the field of health and safety of common use (supplemented by a number of more detailed requirements for certain categories of machines) harmonized standards are being developed to help manufacturers prove compliance with these requirements essential and to enable this compliance to be controlled. In this context, the Horizontal Committee also cooperates with standardization committees, providing them with their comments on standards harmonized with Directive 2006/42 / EC (ie those in which they are included) That the directive defines "only" ?? essential requirements in the field of health and safety of common use (supplemented by a number of more detailed requirements for certain categories of machines) harmonized standards are being developed to help manufacturers prove compliance with these requirements essential and to enable this compliance to be controlled. In this context, the Horizontal Committee also cooperates with standardization committees, providing them with their comments on standards harmonized with Directive 2006/42 / EC (ie those in which they are included)detailed technical solutions regarding the fulfillment of the essential requirements of the directive in the field of health and safety) .It strives to ensure that the requirements included in the harmonized standards properly and fully reflect the requirements of the directive, which, unlike standards, is a registered law and issue a declaration of conformity attesting to CE With the requirements of the directive, when this is not the case, it is a punishable declaration of untruth. Due to the fact that one of the tasks of the Horizontal Committee is to deal with the problems faced by notified bodies during the conformity assessment process of machinery with the essential requirements of Directive 2006/42 / EC, the Horizontal Committee ensures the possibility of > Consultations and mutual arrangements between representatives of notified bodies taking part in its meetings (including fast informing notified bodies about difficult issues discussed about their activities), and also adopts the so-called recommendations for use / recommendations (Recommendations for Use). These recommendations include guidelines agreed within the work of the Vertical Groups for technical and organizational measures that may be used by notified bodies during their conformity assessment processes. Recommendations (RfUs) may have wider application, if they concern many groups of machines or refer to the requirements of the directive - then they obtain the status of so-called horizontal document (horizontal Recommendation for Use sheets); These recommendations include guidelines agreed within the work of the Vertical Groups for technical and organizational measures that may be used by notified bodies during their conformity assessment processes. Recommendations (RfUs) may have wider application, if they concern many groups of machines or refer to the requirements of the directive - then they obtain the status of so-called horizontal document (horizontal Recommendation for Use sheets); These recommendations include guidelines agreed within the work of the Vertical Groups for technical and organizational measures that may be used by notified bodies during their conformity assessment processes. Recommendations (RfUs) may have wider application, if they concern many groups of machines or refer to the requirements of the directive - then they obtain the status of so-called horizontal document (horizontal Recommendation for Use sheets); while when they refer to one group of machines (eg for woodworking), then they obtain the status of so-called vertical document (vertical Recommendation for Use sheets). Recommendations (issued principally when there are no relevant harmonized standards in the given scope or if existing standards insufficiently specify the requirements for machines) adopted by the Horizontal Committee are submitted for approval to the Working Group on Machines, and then they are published on the website of the European Commission [5]. Despite that "recommendations for use" ?? they are not legally binding, after publication on the EC website they are considered as an important source of reference, ensuring uniform interpretation and defining the same rules of applying requirements of the directive by notified bodies. They provide an additional source of information about the requirements of the directive in relation to the "Guide to the application of Directive 2006/42 / EC on machinery" [4]. Despite the fact that the "recommendations for use" are addressed primarily to notified bodies, the interpretation and interpretation of particular aspects related to the implementation of machine conformity assessment procedures adopted by the Horizontal Committee may be used both manufacturers and machine users. This is all the more important because it allows producers access to information that allows to explain particularly difficult problems related to meeting the safety requirements of the products they manufacture. That the "recommendations for use" are addressed primarily to notified bodies, from the interpretation and interpretation of individual aspects developed and applied by the Horizontal Committee, related to the implementation of conformity assessment procedures, both manufacturers can use, as well as machine users. This is all the more important because it allows producers access to information that allows to explain particularly difficult problems related to meeting the safety requirements of the products they manufacture. That the "recommendations for use" are addressed primarily to notified bodies, from the interpretation and interpretation of individual aspects developed and applied by the Horizontal Committee, related to the implementation of conformity assessment procedures, both manufacturers can use, as well as machine users. This is all the more important because it allows producers access to information that allows to explain particularly difficult problems related to meeting the safety requirements of the products they manufacture.

In summary, you can say that "Commendation for Use sheets" ?? serve the following main purposes:

  • help in the interpretation of the requirements of standards
  • supplement information on essential requirements that are not covered by the Machinery Directive or the relevant harmonized standards [6] (indicate possible solutions)
  • provide information on additional ways to meet the essential requirements of the Machinery Directive (in an alternative way), in addition to those indicated in the harmonized standards, in the case of machines placed on the market or in use [7,8]

13. Bibliography

[1] Directive 2006/42 / EC of the European Parliament and of the Council of 17 May 2006 on the unification of machinery regulations, amending Directive 95/16 / EC. OJ L 157, 26, 9/06/2006.

[2] Act of 30 August 2002 on the compliance assessment system. (Ie Journal of Laws 2010, No. 138, item 935, as amended).

[3] Ordinance of the Minister of Labor and Social Policy of September 26, 1997 on general health and safety regulations. (T. j. Journal of Laws 2003, No. 169, item 1650, as amended). Implements into Polish legislation Directive 89/391 / EEC of June 12, 1989 on the introduction of measures to improve the safety and health of workers at work. OJ L 183, 24/05/1989.

[4] Guide on the application of Directive 2006/42 / EC on machinery. European Commission. Enterprises and industry. Second edition, June 2010.

[5] Directive 2006/42 / EC - list of recommendations for Use: http://ec.europa.eu/enterprise/sectors/mechanical/documents/legislation/machinery/notified-bodies/index_en.htm

[6] List of applicable standards harmonized with Directive 2006/42 / EC: http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/machinery

[7] Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 laying down requirements for accreditation and market surveillance regarding the conditions for the marketing of products and repealing the Regulation (EEC) No 339/93

[8] The Blue Guide on the implementation of EU products rules. European Commision, 2014.