“Recommended methodology for specification of safety requirements during designing and manufacturing of a machine”.
1. Introduction
Manufacturers have an impact on the occupational risk associated with the use of machines, because, in manufacturing them, different levels of occupational safety and hygiene can be maintained. According to the legal concept in force in the European Union, consisting in ensuring the protection of safety and health, the designers and manufacturers of new machines must cooperate with their users in this respect. In the context of new machines, activities such as design, construction, and their placement into the market and putting into service are applicable.
The basic directives of the new and global approach [1-3], applicable to machines, have been implemented into Polish legislation by way of regulations [4-6]. Thus, before placing a machine on the market or putting it directly into service, manufacturers in Poland and in the European Union are obliged to ensure and provide documentary evidence confirming that all regulations pertaining to it have been satisfied. The employer (user) on the other hand, in the event of purchase of new machinery and other work equipment, to which the essential requirements pertain, has a legal obligation under Article 217 of the Labour Code [7]. The aim of this is to ensure that new equipment meets the requirements pertaining to the conformity assessment.
2. The scope of application of safety requirements during the design and manufacturing of the machine
The provisions of the machine directive 2006/42/EC, apply to machines, which are to be understood as:
a) an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application
b) the assembly, referred to in item a), missing only the components to connect it on site or to sources of energy and motion
c) the assembly referred to in item a) and b), ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure
d) machine assemblies, referred to in items a)–c), or partly completed machines which, in order to achieve a the same end result, are arranged and controlled so that they function as an integral whole
e) an assembly of combined parts or components at least one of which moves, and which are joined together, intended for lifting loads, whose only power source is directly applied human effort.
Moreover, the requirements of the directive pertain to:
· interchangeable equipment (a device that is mounted by the operator to a machine or tractor and put into service in order to change its functionality or to add a new functionality, if the piece of equipment is not a tool)
· safety components (listed in Annexe 1, used to fulfil a safety function and which are placed on the market separately, and whose damage or malfunction endangers the safety of persons, and which are not necessary for the operation of the machine or can be replaced with normal components so that the machine can operate)
· lifting accessories (a component or equipment not linked to the lifting machinery, including slings and their parts that hold the load, placed between the machine and the load or on the load itself, or which can be an integral part of the load, and are placed on the market separately)
· chains, ropes and belts (designed and constructed for lifting purposes, as part of lifting machinery or lifting accessories)
· removable devices for mechanical power transmission (removable components for power transmission between – by combining them at the first fixed bearing – self-propelled machinery or tractors and other machinery; treated as one product when placed on the market with a cover)
· partly completed machinery (groups of elements forming a machine, which can not be used on their own, their only purpose being incorporation into other machinery or connected with other machinery, or partly completed machinery or equipment, in order to form a machine; they also include the drive system)
The provisions of the 2006/42/EC directive apply to:
· manufacturers of new machines and their authorised representatives
· importers of new machinery from the EU and of all, i.e. new, modified and used machines from third countries
The manufacturer is the natural or legal person, who:
· designs or manufactures machines or partly completed machines covered by the provisions of the 2006/42/EC directive
· commissions their design or manufacture and places them on the market, or uses them internally under its own name or brand
· makes modifications to used machines (changes their design so that they have a different purpose, or new hazards are created, or the risk posed by existing hazards becomes higher).
3. Basic requirements applicable to manufacturers of machinery at the stage of machine design and manufacture
The machine manufacturer must take into account all the risks posed by the machine, and the essential requirements (the use of which will provide sufficient risk reduction), included in the directive’s new and global approach, applicable to it.
It must also be ensured that in the process of designing the machine, all adopted restrictions on its parameters are included, and a division of tasks is made between the machine and its operator(s). The manufacturers must also ensure the availability of technical documentation and the display of necessary information on the machine, as well as to prepare and deliver the machine’s instructions.
Thus, the tasks, with reference to new machines at the stage of manufacture and design, include:
· compliance with the essential requirements provided in the 2006/42/EC machine directive [1]
· compliance with the essential requirements contained in other directives of the new and global approach [2-3], applicable to designed and manufactured machines
· the use of specific guidelines, contained in harmonised standards under the 2006/42/EC machinery directive, the use of which provides a presumption that the machinery is in conformity with the essential requirements of the directive
· demonstration of conformity with the essential requirements in a different way than through the use of guidelines contained in harmonised standards
· the use of risk assessment as a basis for the design and manufacture of machinery to ensure the highest possible level of safety and health, taking into account current scientific and technological knowledge
· the use of a fixed hierarchy of application of protective measures in order to reduce the level of risk in the design of machines, i.e. risk reduction: at the source - inherently safe design; through the application of technical protection measures (shields, protective devices) to reduce the risk associated with non-eliminated hazards; and by posting information for users (on the machine and in the manual) - about the residual risks and the need to apply the necessary measures, mainly organizational and technical
· assessing the conformity of machinery with the essential requirements according to established procedures, taking into account the hazards posed and the associated occupational risks
· preparation, if the result of assessment is positive, of the EC declaration and ensuring its enclosure with the machine, and placement of the CE mark on the machine.
4. Sources of information used in determining safety requirements during the design and manufacture of the machine.
Specifying safety requirements during the design and manufacture of the machine is possible – by the identification of hazards and an assessment of the related occupational risks for the specific scope of the machine’s application.
Occupational risk is understood as a combination of the likelihood of occurrence of a physical injury or the deterioration of health, and their severity. The general rules for hazards identification and assessments of the related occupational risks of machine use are defined in the directive [1] and the regulation [4]. They are specified in detail in EN ISO 12100 [8] and in the guidelines [9], which also include examples of application of these rules. In addition, they are presented in ISO TR 14121-2, providing practical guidelines for performing occupational risk assessments with reference to EN ISO 12100 and describing the various methods and tools used at the different stages of the assessment. This document also provides a variety of measures to be applied in order to reduce occupational risks, and can be used in the design, manufacture, installation and modification of machines.
In determining the safety requirements, other standards harmonised with directives are also used [1–4], the use of which enables fulfilment of the essential requirements of these directives (harmonised standards are not laws, but fulfilment of the guidelines of the harmonised standards are considered as equivalent to the fulfilment of the general requirements of the directive – known as “presumption of conformity”). These standards are drawn up at the request of the European Commission, by the European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardisation (CENELEC) or the European Telecommunications Standards Institute (ETSI), and their content is determined on the basis of the requirements approved by the European Commission. In Europe, the list of harmonised standards is provided in the Official Journal of the European Communities http://ec.Europa.eu/enterprise/policies/european-standards/harmonised -standards/index_en.htm, while in Poland it is published at the web site of the Polish Committee for Standardisation (www.pkn.pl) in the notice of the President of the PCS (MP of 2004 No. 7 item 117, as amended).
In addition, other Polish standards are applicable in Poland, covering such issues as:
- electrical machines
- conditions of work and production systems
- tests and general requirements pertaining to equipment and machine parts
- machines and equipment for rubber and plastics
- office equipment and machines
- engineering drawings
- machines for metal working
- machines used in the textile industry.
These standards may be applied in determining the requirements for safety and health protection during the design and manufacture of specific groups of machines, provided that they do not remain in conflict with the essential requirements laid down in the directives of the new and global approach, and the level of technical detail presented therein does not deviate from solutions currently available.
In determining the requirements for safety and health protection during the design and manufacture of machines, a useful resource for manufacturers can be the “Recommendations for Use”. These interpret the requirements of the harmonised standards or the requirements of the 2006/42/EC directive; mainly for the purpose of harmonising the approach of notified bodies of the European Union to the requirements of this directive. Despite the fact that “Recommendations for Use” are not legally binding, they are regarded as an important source of reference, ensuring uniform interpretation and application of the requirements of the directive by notified bodies, after their publication on the European Commission web site. They represent an additional source of information about the requirements of the directive complementing the aforementioned “Guidelines on the applications of the 2006/42/EC directive on machinery.” These recommendations, adopted by the Horizontal Committee of Notified Bodies, are presented for approval by the Working Group on Machines, after which they are published at the web site of the European Union at the following address:
These recommendations contain the guidelines agreed upon as part of Vertical Groups on the technical and organisational measures that can be used by the bodies during the conformity assessment processes they carry out. Recommendations (RfUs) can also have wider application, if they refer to multiple groups of machines or to the requirements of the directive and then obtain the status of “horizontal document” (horizontal Recommendation for Use sheets); but when they refer to one group of machines (e.g. for woodworking), then they obtain the status of “vertical document” (vertical Recommendation for Use sheets). In principle, the recommendations are issued when there are no relevant harmonised standards in a given range, or if the corresponding harmonised standard does not provide detailed responses to emerging questions.
5. Presenting and documenting the safety requirements of the designed and manufactured machines
The 2006/42/EC directive provides methods of presentation and documentation of the safety requirements.
Such information is present in the technical documentation prepared by the manufacturer. The manufacturer should collect the documentation of manufactured machines (which shall be kept for 10 years from the end of manufacture) comprising:
· risk assessment documentation containing a list of essential safety and health requirements applied when designing the machine and a description of measures taken to eliminate the identified threats posed by the machine or reduction of the risk, and an indication of the residual risk related to the machine
· a list of standards and technical specifications (requirements) used
· a copy of the machine instructions
· a declaration of the incorporation of an installed, partly completed machine with adequate instructions for its installation – if applicable.
· copies of the EC declarations of conformity of the machine or other products incorporated into the machine – if applicable
· a copy of the EC declaration of conformity, in case of serial production
· the description of steps taken to ensure that the machine remains consistent with the essential requirements in the field of safety and health protection
All machines should be marked, and the marking shall be visible, legible and indelible. It should contain at least:
· year of machine construction, understood as the year of completion of its production (completion of the production process in the factory takes place at the latest point in time when the machine leaves the factory for delivery to the importer, distributor or user. If final assembly takes place at the user’s location, this process takes place at the moment of completion of installation and the achievement of operational readiness
· appropriate designation of machines intended for use in explosive atmospheres
· full information regarding the type of machine and what is necessary to ensure safety of use (e.g.: the maximum speed of rotating parts, maximum diameter of tools, and data on the mass of the machine and its parts carried during use by means of lifting equipment)
· Additional information arising from the machinery directive for each specific group of machines.
Safety and health protection requirements in the design and manufacture of machinery are also reflected in the instruction manual, which are an integral part of the machine. The instruction manual should include:
Instruction manual should be drawn up in at least one of the 23 official languages of the EU Member States and have the words "Original Instructions" (in the language of the version) on the language version or versions verified by the manufacturer or an authorised representative. If such instructions do not exist in the official language or languages of the Member State in which the machine will be used, a translation into that language or languages is to be supplied by the manufacturer or their authorised representative or by the person introducing the machinery into the language area. Such instructions should have the annotation “Translation of the Original Instructions.” In justified cases, the machine maintenance manual for specialised personnel (designated and authorised) by the manufacturer or their authorised representative may be written only in the language which is spoken by the personnel. Instructions for the user’s personnel are not covered by this exception. The machine placed on the market or put into service should be provided with the “Original Instructions” and, if applicable, with a “Translation of the Original Instructions.” This will allow the user to consult the original in case of doubt.
In the case of a partly completed machine, the assembly instructions of the incomplete machine must contain a description of the conditions to be met in order to incorporate it into the final machinery, so as not to create a hazard to health and safety. Assembly instructions must be written in an official language of the community, approved by the manufacturer of the machine, into which the incomplete machine is to be incorporated, or by their authorised representative.
The declaration of conformity shall be drawn up by the manufacturer or their authorised representative in the languages identical to the user manual language; it must be enclosed with the machine before placing it on the market or putting into use. It should contain:
· full identification of the machine. The machine data should be the same as that affixed to the machine, but in a complete version. The machine must be uniquely identified. The rule is to provide a factory number. For machines produced in large series, a single declaration of conformity can be issued for the whole series, or lot, but then the scope covered by the declaration must be indicated or a declaration must be issued for each of these machines.
· a statement that the machine complies with the machinery directive and other directives applicable to it; all references must be references to regulations published in the official journal of the EU,
· name, address, identification number of the notified body – in the event that there is approval of a complete quality assurance system, as well as type tests and the number of the certificate issued.
· compliance with the harmonised standards and other standards, if they were used in the conformity assessment process (it is assumed that the indicated standards are applied in their entirety, otherwise, the not applied provisions must be indicated)
· first and family name, and signature of the authorised person
· place and date of preparation.
In the case of a partly completed machine, a declaration of incorporation of a partly completed machine (whose content and translations should be drawn up on the same footing as the instruction manual should include:
1) business name and full address of the manufacturer of the partly completed machine and, where appropriate, their authorised representative;
2) the name and address of a person resident or domiciled in the Community, authorised to prepare appropriate technical documentation;
3) description and identification of the partly completed machine, including a general description, function, model, type, serial number and commercial name;
4) a sentence containing a statement stating that essential requirements of this directive are applied and fulfilled and that appropriate technical documentation was prepared, and, where appropriate, a sentence containing a statement of the conformity of the incomplete machine with other Community directives (these references need to be references to texts published in the official journal of the European Union);
5) the undertaking to provide, upon a justified request of the national authorities, relevant information about the partly completed machine. The undertaking includes the method of transmission and does not infringe upon the intellectual property rights of the manufacturer of the partly completed machine;
6) a statement that the partly completed machine must not be put into service until the final machine, in which it is to be incorporated, is granted a declaration of conformity with the provisions of the present directive, where appropriate;
7) place and date of submission of the declaration;
8) the identity and signature of the person authorised to make declarations on behalf of the manufacturer or their authorised representative.
A way to prove and demonstrate conformity of the machine with the essential requirements and also to perform an appropriate procedure that demonstrates compliance with the essential requirements for machines included and not included in Annexe IV to the directive. For machines which are not included in the Annexe, the manufacturer or their authorised representative shall apply the procedure for conformity assessment described in Annexe VIII to the directive [1], together with a method of internal control of machine manufacture, In the case of machinery listed in Annexe IV to the directive, which were not produced in accordance with the relevant harmonised standards (mainly with type C standards) or meet them only partially, or the applied standards do not cover all the essential requirements, or there are no such standards, the manufacturer or their representative may apply:
Finally, in the case of machinery listed in Annexe IV to the directive, manufactured in conformity with the relevant harmonised standards, including all of the essential requirements for the machine, the manufacturer or their representative may apply:
The CE marking on the machine confirms compliance with the essential requirements for safety and health protection. It indicates compliance with all EU regulations that stipulate the CE marking, it should conform with the reference model provided in Annexe III to the directive. It must be placed in the immediate vicinity of the name of the manufacturer or their authorised representative, using the same technique. In the case that full quality assurance in the conformity assessment procedure is applied, the CE marking should be followed by the number of the notified body which provided the certification.
6. Measures to be applied in order to ensure safety and health protection be taken into account when a machine is designed and used
These measures are set out in Annexe 1 to the directive [1] and are divided into requirements that apply to all machines, as well as those relating to specific groups of machines. The essential requirements covering all machines include:
ü reliability, construction, arrangement and operation of controls;
ü starting and stopping (in normal and emergency mode);
ü selection of work type;
ü interference in power supply and in control circuits;
ü software.
ü inadequate stability;
ü breaking up (wires, connections, etc.);
ü falling and ejected objects;
ü surfaces, edges, corners;
ü multifunctionality of the machine;
ü changes of tool speeds;
ü moving parts;
ü incorrect selection of protective equipment;
taking into account the use of covers and protective devices (general requirements and those pertaining to specific types);
ü maintenance;
ü access to work stations and operating positions;
ü isolation from energy sources;
ü other interventions by the operator;
ü cleaning of parts and zones inside the machine;
§ information means and components, including:
ü warning against permanent hazards (pictograms);
ü information;
ü marking;
ü operating instructions (OMM).
7. Examples of Recommendations for Use , published on the website of the European Commission, relating to the essential requirements of the 2006/42/EC directive
Document CNB/M/00.251
It explains the procedure to be followed by the manufacturer and the notified body during type assessment according to the 2006/42/EC directive. It pertains to the procedure followed by a notified body in the event that a modified machine is assessed after an earlier version (before modifications) was assessed by a different notified body. In accordance with the recommendation, the manufacturer making the changes in the machine should ask the notified body assessing the original product whether the type-examination certificate it issued may remain valid with respect to the changed product. If the body informs them that the current certificate is no longer applicable, the manufacturer may uphold their intention to place the modified product on the market but as a new type, requiring a reassessment of the essential requirements. This evaluation can be performed by another notified body, but then that body assumes responsibility for the whole product and acceptance and evaluation of all documents submitted by the manufacturer is up to that body (including previous certificates and test reports)
Document CNB/M/00.251
This pertains to the rule of taking into account all aspects of safety in an EC type evaluation. However, it indicates that in justified cases a departure from this basic principle is possible, if it does not have negative effects on the safety of the product. This document lists the cases of possible departures from the rule of taking into account all aspects of safety in an EC type evaluation; e.g.:
· for machines intended to be used in buildings, the temperature range of tests can be limited to the 0°–50° range,
· if the evaluated machine will be used indoors and is intended to be mounted in an enclosure, e.g. of IP 54 protection (limited protection against dust and against water splashing), then there is no justification for examining the IP code [5] of the machine itself,
· it is possible to omit the tests for immunity of the safety related control system components to electromagnetic interference, if the components are only electromechanical.
However, all departures of this type should be listed in the EC type examination certificate. Of course, the examination safety aspects must not be ignored as part of EC type-examination if there is no guarantee that the requirements for all aspects will be fulfilled.
Document CNB/M/01.087
This pertains to the EC type examination of portable chainsaws with electric battery power supply for tree service, for which there is no harmonised standard, because the standards EN 60745-1 [11] and EN 60745-2-13 [12] pertaining to electrically driven saws and EN ISO 11681-2 [13] pertaining to combustion engine driven chain saws for tree service are not fully applicable to them. The document points to the high risk of performing this type of work using conventional electric saws with power cables. Type examination of electric battery powered chainsaws for tree service should be performed taking into account the applicable sections of the following standards:
· EN 60745-1 and EN 60745-2-13 - for electric requirements and
· EN ISO 11681-2 - for non-electric requirements.
Document CNB/M/04.064
This pertains to detailed requirements for the operation of the emergency stop device in injection molding machines for plastics. In accordance with this recommendation, the activation of this device should not disconnect power from the heating devices, because it will not result in an immediate reduction of the risks associated with the high temperature of the machine components. In addition, temperature reduction can cause additional hazards associated with the ejection of partly cooled and then reheated plastic when the machine is restarted. However, the machine operating instructions should include adequate information regarding the operation of the emergency stop device, including a warning that it does not shut off power to the heating elements
9. Examples of bringing machines into conformity with the essential requirements for safety and health protection
Example 1
The declaration of conformity does not indicate the person responsible for the preparation of the technical documentation.
Failure to comply with the requirement of Annexe 2 A to the 2006/42/EC directive “The EC Declaration of Conformity must indicate the following detailed information: ……..2) the name and address of a person resident or domiciled in the Community, authorised to prepare appropriate technical documentation…”
The declaration of conformity should be supplemented with information about the legal or natural person appointed by the manufacturer, domiciled or resident in the EU, responsible for providing the machine documentation.
Example 2
A control part remaining in the machine in its neutral position is not marked as regards the required direction and effect of its activation.
This fails to comply with item 1.2.2 of Annexe 1 to the 2006/42/EC directive “Control devices must be: — clearly visible and identifiable and appropriately marked with pictograms where necessary, — positioned for safe operation without hesitation or loss of time, and without ambiguity, — designed so that the direction of movement is consistent with its effect,…”.
The control device must be appropriately labelled, indicating the direction of its activation in accordance with the designed and intended effect.
Example 3
The machine was provided with a interlocking movable guard, but when the operator opens it, they have access to a component of the machine moving under the force of inertia.
This fails to comply with item 1.4.2.2 of Annexe 1 to the 2006/42/EC directive “…….When the operator can reach the hazardous zone before the risk connected with the hazardous functions of the machine ceases, moving guard must be connected with a guard locking device supplementing the interlocking device, so as to: — prevent the start of hazardous functions of the machine until the covers are closed and locked, and — keep the guard closed and locked until the risk of injury resulting from hazardous functions of the machine ceases.”
A movable, interlocking guard with a lock must be used instead of a movable interlocking guard. Installation of a guard locking device to supplement the interlocking device is necessary when the operator can reach the hazardous zone before the risk connected with the hazardous functions of the machine ceases. The time during which the guard is kept locked should be sufficient for the hazard to cease. In accordance with the requirement of the machinery directive, the interlocking movable guard must also be designed in such a way that the absence or damage of one of their components prevents starting or stops the hazardous machine functions. This is associated with the fulfilment of the requirements for the safety and reliability of control systems.
Example 4
In a machine with a manual feed, the installed fixed guard does not restrict access to the moving part of the machine.
This fails to comply with item 1.4.2.3 of Annexe 1 to the 2006/42/EC directive “Adjustable guards restricting access to those sections of moving parts that are necessary to perform work must be: — adjustable, manually or automatically, depending on the type of work, and — easily adjustable without the use of tools”
An adjustable guard must be used in a machine where it is impossible to completely prevent access to the hazardous zone near the moving tool. To minimise the risk of contact with the tool, it is important to facilitate the adjustment of the guard according to the dimensions of the processed workpieces. The guard can be designed and made so that its position is adjusted automatically to the dimensions of the workpiece, if it does not cause additional risk. Otherwise, the operator must be able to quickly and easily adjust the position of the guard without the use of tools [9].
7. References
[1] Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC. L 157/24. 9.6.2006
[2] Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to Electrical Equipment designed for use within certain voltage limits. L 374/10. 27.12.2006.
[3] Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC. L 390/24. 31.12.2004.
[4] Regulation of the Minister of Economy of 21 October 2008 on Essentials requirements for machines (Journal of Laws No.199, item 1228, with later. edited)
[5] The Law of 21 April 2007 on electromagnetic compatibility (Journal of Laws No. 82, item 556, with later. edited).
[6] Regulation of the Minister of Economy of 21 August 2007 on essential requirements for electric al equipment (Journal of Laws No.155, item 1089).
[7] The Law of 26 June 1974 – Labour code (Uniform text Laws of 2008 No. 21, item 94, with later edited)
[8] EN-ISO 12100: 2012 Safety of machinery - General principles for design - Risk assessment and risk reduction
[9] Guide to application of the Machinery Directive 2006/42/WE. European Commision. Enterprise and Industry.2nd Edition, Jube 2010. http://ec.europa.eu/enterprise/sectors/mechanical/files/machinery/guide-appl-2006-42-ec-2nd-201006_en.pdf
[10] ISO TR 14121-2:2012 Safety of machinery – Risk assessment – Part 2: Practical guidance and examples of methods
[11] EN 60745-1:2009+A11:2010 Hand-held motor-operated electric tools. Safety. General requirements.
[12] EN 60745-2-13:2009+A1:2010 Hand-held motor-operated electric tools. Safety. Particular requirements for chain saws
[13] Machinery for forestry -- Portable chain-saw safety requirements and testing -- Part 2: Chain-saws for tree service