1 General principles

In accordance with the methodology of determining the safety requirements during the design and production of a new machine, in the conformity assessment process the requirements set out in directive 2006/42/EC should be fulfilled with the help of selected scope of harmonized standards. The recommended general algorithm for the procedure is as follows:

1. Will the specific requirement of directive 2006/42/EC be implemented using the type C harmonized standard (standard containing specific requirements for the selected machine or group of machines)? If yes, then the scope of the requirement does not require to carry out a detailed risk assessment, but specific solution associated with the application of specific safety measures from the type C standard needs to be indicated. The fulfilment of the requirements must be documented through appropriate records, and it is advisable to draw up a collective checklist for specific requirements of type C standards covering a specific set of requirements of directive 2006/42/EC. This procedure is recommended in the case of availability of detailed solutions in the application of security measures in the relevant type C standard, provided that the machine designer decides to use proven solutions. In the event of an innovative approach to solve safety issues of the machine, it is recommended to proceed in accordance with point 2 or 3.

2. Will the specific requirement of directive 2006/42/EC be implemented using the EN ISO 12100:2010 harmonized standard Safety of machinery – General principles for design – Risk assessment and risk reduction (type A general standard with basic safety requirements relating to all machines)? If yes, then a risk assessment should be conducted with regard to specific requirements and safety measures should be selected from among the recommended safety measures. Type B standards (thematic safety standards) related to the safety aspects (type B1 standards) or one type of technical safety measures, which can be used in many different machines (type B2 standards), should be used here. Type B1 standards include recommended methods of risk assessment, for example related to the noise, temperatures, requirements of functional safety of safety-related machine control systems, etc. Type B2 standards contain requirements for the construction and use of technical safety measures (protective), for example guards, electrosensitive protective equipment, protective devices sensitive to pressure, two-hand control devices, etc. This procedure is recommended in the case of equipment for which type C standards have not been developed, i.e. unique machines or technological lines composed of a number of different interconnected machines. The fulfilment of the requirements must be documented in a way that shows how to carry out risk assessments and reasons for selection and application of specific security measures.

3. Will the specific requirement of the 2006/42/EC directive be implemented based on the provision of the directive? If yes, then according to this requirement it is necessary to carry out a risk assessment, which in practice is carried out only by checking the application of proven solutions. The use of innovative methods of risk assessment and selection of security measures require careful documentation of their effectiveness and suitability of the considered aspects.

The fulfilment of the essential requirements of the 2006/42/EC directive is carried out based on a prepared checklist, which contains a reference to the risk assessments associated with various hazards and emergencies and to the results of the selection of security measures. The adopted principle of creating such checklists consists in providing an answer (affirmative, “yes”) when the fulfilment of the requirement is confirmed, or, if the question, for some reason, does not apply to the machine or is not considered in the fulfilment of the requirement (inspection), or a negative (“no”) answer if the fulfilment of the requirement cannot be confirmed.

Each question (aspect) on the checklist is a separate (partial) requirement related to all hazardous situations applicable, whose fulfilment or non-fulfilment is subject to independent assessment. If the requirement does not apply to the inspected machine (the hazard does not occur in the machine or its functional properties are not related to the essence of the requirement), then at this point the requirement fulfilment evaluation process is completed and for the collective assessment of compliance with essential requirements a positive result is assumed. This allows to easily carry out a cumulative assessment of compliance with the essential requirements, which is positive if all the partial results are positive. If the checklist contains at least one negative partial result, then the collective assessment of compliance is negative. This means that the assessed machine (or its design) requires action to restore it to the state of compliance with the OSH requirements.

Conducting the assessment of compliance with the essential requirements for machinery based on developed checklists, using support in the form of computer tools, requires the development of an electronic assessment form(s). Such form(s) allows the evaluation result of each partial requirement to be developed in a unified way, and the cumulative result of the assessment to be established, also in a unified way.

In addition to the basic checklist for assessing the fulfilment of the essential requirements, checklists for risk assessment in certain emergency situations will be useful.

1.1 Risk assessment in the conformity assessment process

The fulfilment of a specific essential requirement is associated with performing a specific design operation, which amounts to performing the risk assessment procedure — note that the full execution of all stages of the procedure is not always required. It should be noted that the full procedure for strategy assessment and risk reduction covers (see points 4 and 5 of the EN ISO 12100:2010 standard):

- determining the limitations of the designed machine (see point 5.3 of the EN ISO 12100:2010 standard);

- hazard and hazardous situations identification — in this regard point 5.4 of the EN ISO 12100:2010 standard will be helpful;

- risk estimation and evaluation (see: EN ISO 12100:2010 standard, item 5.5);

- risk evaluation (judging) and decision regarding the use of safety measures (see: EN ISO 12100:2010 standard, item 5.6);

- the use of safe solutions which allow for the elimination of hazards or specific hazardous situations (see point 6.2 of the EN ISO 12100:2010 standard) — in the application of solutions safe by themselves appropriate design solutions are considered, including: taking into account the geometric and physical aspects; taking into account the general technical knowledge in field of machine design; selection of appropriate technology; application of the principle of mechanically forced interaction; taking into account the principles of stability; taking into account the principles of ease of use; taking into account the principles of ergonomics; taking into account solutions which reduce the risks associated with electrical hazards and risks arising from the use of pneumatic and hydraulic equipment; taking into account solutions which reduce risk in control systems and the risk of faulty safety functions; reducing exposure to hazards by the durability of equipment; reducing exposure to hazards by mechanisation or automation of feeding/receiving; reducing exposure to hazards by locating the setup and maintenance stations outside the hazardous area;

- the use of technical security measures to reduce the risk (see point 6.3 of the EN ISO 12100:2010 standard) — in the application of technical security measures the issues of selection and use of guards and protective devices are considered, as well as the requirements for the design of guards and protective devices, the application of technical safety measures which reduce emissions;

- the use of supplementary safety measures to reduce the risk (see point 6.3.5 of the EN ISO 12100:2010 standard);

- development of information on the usage (see point 6.4 of the EN ISO 12100:2010 standard) — including in particular the location and type of information regarding the use, signalling and warning devices, markings, symbols and warning labels, accompanying documentation including user manual.

Identification of hazards and hazardous situations and the use technical and supplementary safety measures are crucial to meet the essential requirements. The residual risks remaining after the machine gets equipped with designed safety measures is essential, as well as the information on safety measures which should be implemented by the machine user after its installation at the production site.

After filling in, the form for assessing compliance with the essential requirements for the machine should be the basic document serving as a proof of proper risk assessment and appropriate selection of security measures. For this reason, its content is tailored to the type of hazards, hazardous situations and safety measures applied. In addition, the form should include information that should be communicated to its future users, that is the information on residual risks, the need to use additional security measures on the side on the employer (e.g. the use of personal protective equipment, organizational measures and proper lighting of the place where the machine is used).

Considering the above demands, the form of assessing compliance with the essential requirements should include the following:

- the symbol of the form — a unique code that identifies the type and subsequent version of the electronic form;

- the machine ID — a unique alphanumeric code associated with the machine;

- date of the electronic form — this date should be the date of the start of evaluation of fulfilment of the essential requirements;

- name of the machine, its type, and, if relevant, information on the series of types;

- description of the machine — a short information about intended uses;

- information about the limitations of the machine;

- information about prohibited methods of operation;

- identification of the essential requirements of the 2006/42/EC directive (in accordance with the points of annex I, the content of the point);

- information whether this requirement concerns the machine — indicate “yes” or “no”;

- information whether this requirement has been fulfilled — indicate “yes” or “no”;

- description of hazardous situation — the hazardous situation should relate to a particular requirement of the 2006/42/EC directive;

- type of expected risk assessment — it is expected that the risk assessment can be carried out: a) in accordance with a type C standard; b) in accordance with the EN ISO 12100:2010 standard and type B standards; c) directly in accordance with the 2006/42/EC directive with the application of proven safety measures;

- basis of risk assessment — an indication of the risk assessment method or document (standard) on the basis of which an assessment of the risk was carried out;

- risk assessment result — presentation of the results of the risk assessment and indication of a document containing detailed information or indication of a declaration of conformity or a declaration of partly completed machine, based on which the fulfilment of the requirements was determined;

- safety measures applied — presentation of safety measures which allow the risk to be reduced to the level required by the 2006/42/EC directive, divided into: solutions safe by themselves, technical safety measures (basic and supplementary), security measures expected to be introduced by the user;

- information about the residual risks — applies to residual risks remaining after the implementation of those safety measures — it can be specified by indicating the document containing it;

- information for the user of the machine — this information should be linked to the merits of the requirement of the 2006/42/EC directive and should include information on the risks, applied safety measures, operational requirements associated with these safety measures (e.g. on the frequency and method of carrying out periodic and ad-hoc inspections), the residual risks, the scope of the required training for employees and others — it can be specified by indicating the document containing it;

- the final result of the assessment of compliance with the 2006/42/EC directive requirements — for each of the requirements;

- the final result of the assessment of fulfilment of the 2006/42/EC directive requirements — representing the summary of the whole evaluation of fulfilment of essential requirements conducted for the machine;

- identification of assessors carrying out the assessment of meeting the essential requirements of the 2006/42/EC directive by the machine;

- a list of related documents (including electronic forms, annexed to the main electronic form of assessment of compliance with the essential requirements of the 2006/42/EC directive).

The form symbol, ID of the machine and the form date together constitute a unique identifier of the assessment of the fulfilment of the essential requirements related to the particular machine. This identifier will be included as part of the name of the file which includes the data from the form. Subsequent assessments of meeting the essential requirements for this machine (made in subsequent stages of the project) will have different form date, provided that the subsequent assessment will be carried out with the use of the same version of the form.

When assessing compliance with the essential requirements of the machine it certainly will be necessary to use additional complementary forms, especially in the conduct of specialized risk assessment for the some of the risks and the selection of related safety measures. The use of these forms should be recorded in the main form. The documentation of risk assessment and meeting the essential requirements will be the main form of assessing compliance with the essential requirements carried out in accordance with the 2006/42/EC directive requirements including any additional forms referenced in the main form.

The risk assessment methods which should be included in the assessment of essential requirements should include quantitative methods (for hazardous aspects that can be measured) or qualitative methods. In the case of quantitative methods for risk assessment, it is always necessary to carry out the measurement with a specific method. In the case of a qualitative risk assessment, the elements of risk should be determined through analysis and the risk should be estimated, first taking into account the situation before applying a safety measure, and then after its application.

1.2 Identification of hazards, hazardous situations and safety measures

The list of hazards, hazardous situations and safety measures should be created for a particular machine. Each of the 2006/42/EC directive requirements must include relevant hazards, hazardous situations and safety measures applied for this purpose in the machine. A given essential requirement may have several types of description assigned, depending on the conditions existing in the machine (a list). In the process of assessing compliance with the essential requirements, the list should be verified for its completeness (whether it covers all hazards and safety measures used in the machine) and suitability (if all listed hazardous situations actually occur). Work situations should also be taken into account when determining hazardous situations.

The reasons for updating the list of hazards, hazardous situations and safety measures applied can be as follows:

‒ upgrade or modification of both the machine and safety measures used within the machine;

‒ change of the assortment of the production;

‒ changes in the environment of the machine;

‒ changes in the perception of hazards and hazardous situations associated with the machine as a result of an accident, a non injury incident and circumvention of the installed safety measures (protective devices);

‒ strengthening of the requirements as a result of the development in the OSH field resulting in the reduction of acceptable risk level, which can be associated with new requirements in terms of risk levels acceptable for already identified hazards and hazardous situations and the need for risk mitigation in the event of hitherto unidentified hazards.

1.3 Hazards and hazardous situations

According to the definition, hazardous situations are events in which a person is exposed to at least one hazard. Human exposure is often the consequence of performing a task at a machine. Hazardous situations include:

a) carrying out the work near moving parts;

b) exposure to ejection of parts;

c) working under a suspended load;

d) working near objects or materials of extreme temperatures;

e) exposure of an employee to hazards caused by noise.

In practice, hazardous situations are often described as tasks or execution of tasks (manual feeding parts to the press and/or receiving parts from the press, troubleshooting under voltage, etc.). It is recommended that the hazardous situations description (the type of hazard, its potential consequences, its source and place of occurrence) be unambiguous and supplemented with other available information (task carried out by an employee, hazardous area description). In practice, hazardous situations are presented by determining the tasks that need to be carried out by the employees (e.g. manual feeding parts to the press and/or receiving parts from the press, troubleshooting under voltage, etc.). This is acceptable provided that such a description of a hazardous situation will be sufficient to estimate the risk.

There is no complete list of hazards that can be related to a machine. Additionally, different work situations can vary in terms of the list of hazards and hazardous situations. Only the basic risks can be provided, which may occur in mutual combinations, thus creating risks of a specific nature, which are usually closely related to the hazardous situation. The use of security measures to reduce the risk also creates a particular hazardous situation associated with a defect in these measures. By defect we understand here the loss of the ability of a safety measure to fulfil its functions. Taking this risk into account is particularly important in the case of safety-based control methods, but it can be important also for all other types of security measures.

It is recommended that a description of a hazardous situation be clear and presented using available information (performed task, hazard, hazardous area).

1.4 The positive result of the assessment of compliance with the essential requirements

The determination of compliance of the machine with the essential requirement of the 2006/42/EC directive (the item in annex I to the directive) ends the assessment process for this requirement.

The non-compliance with a specific essential requirement needs to be removed by looking for further or other safety measures, until the residual risks are brought to an acceptable level. It is difficult to determine the measures required to achieve that objective; there could be, for example, a need to use highly innovative solutions.

Figure 1. Algorithm of conduct during the risk assessment in the conformity assessment process

Before introducing the machine on the market (delivery to the future user), it is required to comply with all the elementary requirements. It is acceptable to derogate from certain requirements, if after exhausting all reasonably possible solutions the achievement of the level of risk which would be consistent with the requirements would be unreasonable because of the very high costs, unacceptable nuisance when operating the machine, high risk of defects of safety measures, and similar causes.

The algorithm for assessing risk in the conformity assessment process is shown in figure 1.

Design of control-based safety measures

The use of control-based safety measures is a commonly used method of reducing the risk when using the machine. In the case of implementing such a safety measure, the checklist for fulfilment of essential requirements includes only the general requirement of the use of an appropriate solution which ensures a certain reliability throughout the lifecycle of the machine, and any fault should not cause a hazardous situation. Achieving such a solution is related to the fulfilment of a number of specific requirements that can be found in the relevant harmonized standards. The level of resistance to faults related to the safety of the control system is determined based on the risk assessment. For this purpose, you can use the methodology of risk assessment and evaluation of fulfilment of specific requirements proposed in the two-part harmonized standard:

- EN ISO 13849-1:2008. Safety of machinery -- Safety-related parts of control systems -- Part 1: General principles for design,

- EN ISO 13849-2:2012. Safety of machinery -- Safety-related parts of control systems -- Part 2: Validation.

1 Design assumptions concerning the safety functions

The first step of the designer is always to determine the limits of the machine. In the case of the control system, it will consist in identifying security functions performed by the control system. Further procedure is carried out independently for each safety function.

Then, each safety function should be described in detail, including the functional parameters. Depending on the complexity of security features and the design of the control system, the designer selects the standards that apply to the risk assessment and the assessment of the resilience of the control system to defects. Further design process depends on the selected standard.

2 The application of EN ISO 13849-1:2008 standard

Algorithm of conduct when using the EN ISO 13849-1:2008 standard is present in fig. 2.

Fig. 2. Algorithm of conduct when using the EN ISO 13849-1 standard.

The general design stage begins with a risk assessment to determine security requirements and the required performance level (PL_w). This will be done using the risk graph shown in Annex A to the EN ISO 13849-1:2008 standard.

Then, the designer selects the method of implementing the requirements related to the required performance level. For this purpose, the designer determines the category of the control system, its structure, performance requirements of reliability, and design assumptions. After the formulation of assumptions, the stage of detailed design commences.

Designing the control system is done using currently available professional software, for example CAD. These activities are carried out outside the system which supports the assessment of compliance. However, the design results are part of the required documentation to be collected.

At the detailed design stage, the achieved performance level should also be evaluated. It requires:

- to calculate the MTTF parameter;

- to determine the DC parameter;

- to determine the CCF parameter;

- measures to prevent systematic defects;

- software assessment.

If the determined performance level (PL) is lower than specified based on the risk assessment (PLw), it will be necessary to return to the formulation of safety assumptions and re-execute the detailed design.

If the result of the PL verification is positive, it will be possible to proceed and prepare detailed design and implement the safety-related control system which will execute the analyzed safety function.

The designed safety function is subject to validation, which should be carried out in accordance with the requirements of the EN ISO 13849-2:2012 standard. For this purpose, the following need to be carried out:

- develop the validation schedule;

- carry out necessary tests and checks;

- prepare the validation report.

The negative result of validation means failure of one of the specific requirements and the need for changes in the project. For this reason, it is recommended that the validation was carried out early at the design stage and continued until a positive final result.

The positive result of the validation process means completion of the design stage and implementation of a safety-related control system which will execute the analyzed safety function. This process should be carried out independently for each safety function (groups of related safety functions).

3 Evaluation of compliance with the EN ISO 13849-1:2008 and EN ISO 13849:2012 standards

The evaluation of compliance with the requirements of EN ISO 13849-1:2008 and EN ISO 13849:2012 standards requires filling in a checklist. In the list, please refer to the following evaluation points:

- risk assessment — determination of the required performance level — requires to determine the severity of damage (S1, S2), the frequency of exposure (F1, F2), and the probability of avoiding damage (P1, P2), and, on this basis, the required performance level PLw (a, b, c, d, e);

- determining the design requirements related to the safety functions — requires to determine the category of the control system (B, 1, 2, 3, 4), the required mean time to dangerous failure MTTF (low, average, high), and the required diagnostic coverage DC (no coverage, low, average, high);

- defining technical and environmental conditions and influence of recycled materials, taking into account the limits of the machine — to be prepared and the documentation to be indicated;

- safety plan — to be prepared and the documentation to be indicated;

- design documentation of safety functions (block, schematic, assembly diagrams of systems, functional description, signals time sequence diagrams) — to be prepared and the documentation to be indicated;

- determining the type of power supply used in safety-related control system — the type of systems required to be indicated;

- software of safety-related control system — optional requirement — must be met if the control system uses programmable elements — the software to be prepared and the documentation to be indicated;

- components used in the design of safety functions — a list of elements to be prepared, and, based on that, the mean time to dangerous failure to be determined, and the documentation to be indicated;

- dangerous defects in the designed safety function implementation — a list of potentially dangerous failures and assessment of diagnostic coverage to be prepared, and the documentation to be indicated;

- safety rules included in the security functions design — the safety principles used to be prepared based on additional checklist, and the documentation to be indicated;

- common cause failures — optional requirement — must be met if the control system uses a multi-channel architecture — requirements fulfilment must be assessed based on a detailed checklist, and the documentation needs to be indicated;

- measures to prevent systematic defects — the assessment of fulfilment of the requirements on the basis of additional checklist needs to be carried out, and the documentation needs to be indicated;

- laboratory tests and prototype tests — documentation from tests needs to be indicated;

- software testing — optional requirement — must be met if the control system uses programmable elements — the documentation confirming the tests results to be indicated;

- other requirements — optional requirement — determine its type and indicate the documentation confirming the fulfilment of requirements;

- description of safety functions for the user and procedures of checking the safety functions — the documentation containing the required information to be indicated;

- determining the achieved performance level (PL) — the performance level (PL) related to the implemented control system executing the safety function to be determined and confirmation that the determined design objective was achieved in terms of requirements related to the risk assessment;

- validation report — the documentation containing the validation protocol to be indicated.

Electric lighting

1 Description of the method of risk assessment

The parameters of the electrical lighting which can decide about the occupational risk are as follows:

· operational illuminance;

· uniformity of illumination;

· occurrence of direct glare;

· occurrence of reflective glare;

· flickering and pulsating light;

· stroboscopic effect;

· colour rendering index.

The method of risk assessment consists in filling in the checklist, the template of which is shown in annex 20, and carrying out the risk assessment based on that. If the response to a question in the checklist is “NO”, then the recommended level of potential risk is indicated next to the item.

When assessing the risk concerning lighting, three-level scale of risk is used: small, average (acceptable, but it is advisable to introduce corrective actions) and high (unacceptable, it is necessary to immediately introduce corrective actions). The basic criterion for risk assessment are the requirements of the lighting standard EN 12464-1:2011. If these requirements are fulfilled, it can be concluded that the risk is small. The final risk level is the highest risk level determined.

In the case of nonconformity, average or high risk, actions to reduce risk need to be taken to reduce it as much as it is technically possible for all individual nonconformities identified in the checklist.

If there is no “NO” response in the checklist, the assumed risk is low.

As a reference, the division into three levels of risks is shown in fig. 3.

Fig. 3. Diagram for determining the level of risk regarding the occurrence of improper electric lighting

In the case of machines in which there are rotating or reciprocating elements (e.g. woodworking machines, lathes, milling machines, drills, grinders, etc.), if improper lighting can lead to an accident at work due to the stroboscopic effect, the risk should be considered high.

Also, when reflective or blinding glare of high intensity caused by excessive luminance of used light sources or improper lighting luminaires occur in the vicinity of the machine, the risk should be considered high.

In the case of occurrence of flickering or pulsating light, which can increase the physiological effects such as headaches, due to installation of faulty ignition systems or light sources designed to illuminate the machine, the risk is considered as average.

2 Requirements for integral lighting of machines.

The machine must be equipped with integral lighting where the absence thereof is likely to cause a risk despite ambient lighting of normative intensity. This is particularly important when the design of the machine and/or used guards make the general lighting not sufficient to illuminate the work area and the areas in which the adjustment, setting and frequent maintenance are carried out. The lighting of the machine can be implemented by means of local luminaire(s) mounted on the machine or inside the machine. The lighting must be designed and constructed so that there is no area of shadow likely to cause nuisance, irritating glares and that there are no dangerous stroboscopic effects on moving parts due to the lighting. If the position of a light source is adjustable, a change of position should not present any risk to people performing the adjustment.

The excessive luminance of lighting can be reduced by covering it with semi-transparent (e.g. opal or mat lampshade) or opaque (e.g. louver) materials. In the design practice, it involves the choice of appropriate luminaries and positioning them so as to prevent the occurrence of discomfort glare. The occurrence of interfering or, especially, blinding glare is unacceptable. It is assumed that the reduction of discomfort glare reduces the possibility of occurrence of interfering glare.

Prevention of flickering of the luminous flux emitted by gas-discharge light sources should be carried out at the design stage of the lighting. This is particularly important in the case of lighting the machines with rotating or reciprocating parts. These include, in particular, the prevention of the stroboscopic effect, which may cause accidents at work, especially upper limb injuries. Therefore, already in the design phase, this phenomenon must be taken into account by the use of electronic ignition systems (which increase the frequency of the pulse ignition) in the case of discharge sources (lamps), or the use of glow sources (halogen lamp) or LED sources.

Local luminaires installed on the machine or inside the machine should be designed to minimize the accumulation of dirt on the lamps and optical systems and premature aging of optical components. Additionally, they should be hermetic (corresponding IP level in relation to factors occurring in the machine (coolant, dust, etc.) and should be resistant to, for example, vibrations (use of appropriate light sources, e.g. LED), or optical radiation). The luminaire should be mounted in a place that has no impact on the tasks performed and the hazards towards the operator.

3 Risk evaluation

3.1 Illuminance

Operational illuminance is defined as the lowest value of average illuminance, which should be maintained in a specific area during the whole time of lighting use. The PN-EN 12464-1:2012 Polish standard determines detailed requirements for operational illuminance depending on the type of activity.

Occupational risk assessment analysis due to the occurrence of a factor of negative impact — electrical lighting — the illuminance level requires the measurement of the illuminance in the task area, i.e. in the area in which an employee carries out a visual work related to the operation of the machine. Then the average illuminance E_avg should be determined in accordance with the formula (1).

E_avg = (E₁+ E₂+ ... + E_n)/n (1)

where:

E₁, E₂,....E_n — illuminance values at individual measurement points of the task area

n — the number of measurement points.

In order to assess occupational risks associated with illuminance, proceed as follows:

· measure the illumination at points uniformly distributed in the task area of the tested machine;

· calculate the average illuminance in the task area;

· check the PN-EN 12464-1:2012 standard for requirements related to operating light intensity for a given activity;

· compare the value of the average illuminance values which constitute the criterion of assignment to a certain degree of risk, as presented in annex 21.1;

· in accordance with the criteria set out in annex 21.1, determine the degree of occupational risks associated with illuminance;

· in the case of determining a few task areas for the assessed machine, repeat the above steps, and assume the higher level of risk as the final result of the risk assessment.

3.2 Uniformity of illumination

The numerical value of this parameter determines whether there are dimly lit areas in a given area. The uniformity values take the value ranging from 0 to 1; the closer they are to 1, the higher the uniformity. Dimly lit areas or shadows of the elements of equipment in the visual task area cause unevenness of illumination.

The PN-EN 12464-1:2012 standard sets out minimum values of uniformity of illumination in the task area depending on the type of activity carried out, and in the communication zones in work rooms.

Occupational risk assessment analysis due to the occurrence of a factor of negative impact — electrical lighting — the uniformity level parameter requires calculation in accordance with the formula 2. Uniformity of illumination (U₀) in a given area is the quotient of the smallest measured illuminance value (E_min) occurring in the area and the average illuminance in the area (E_avg).

U₀ = E_min/E_avg(2).

In order to assess occupational risks associated with the uniformity of illumination, proceed as follows:

· based on the measurements of illuminance calculate, in accordance with the formula 2, the uniformity of illumination;

· compare the determined values of the uniformity with the values provided in table 3;

· in accordance with the criteria set out in annex 21.2, determine the degree of occupational risks associated with uniformity of illuminance;

· check the PN-EN 12464-1:2012 for requirements for operating uniformity of illumination for a given activity (U_0PN);

· in the case of determining a few task areas for the assessed machine, repeat the above steps, and assume the higher level of risk as the final result.

3.3 Glare

Glare is a process (state) of view, where there is a feeling of discomfort or reduced ability to recognize objects, or both, as a result of improper luminance distribution or excessive contrasts in space or in time.

The assessment for glare at work stations should be carried out by means of measurement of luminance of sources of glare, which occur in the field of view of the employee during the execution of common tasks while operating the machine. In order to assess occupational risks associated with glare, proceed as follows:

· measure the luminance of the source/sources of light, which occur in the field of view of the employee during the execution of common tasks while operating the machine; the measurements should be carried out in the place corresponding to the position of the eyes of the employee;

· choose the maximum value of the measurement of luminance.

Occupational risk assessment analysis due to the occurrence of a factor of negative impact — electrical lighting — glare parameter consists in the comparison of the maximum luminance values with the values provided in annex 21.3, and, based on that, determining the level of occupational risk associated with glare.

3.4 Quality of lighting

Colour rendering properties of light sources are characterized by the so-called colour rendering index (R_a), which is a measure of the degree of colour of an object illuminated with a particular light source, with an impression of colour of the same object illuminated by a source of reference under certain conditions. The maximum possible value of this indicator is 100 and it is taken for sunlight and glow sources (including halogen). The required precision of colour rendering in the electric lighting conditions depends on the type of work performed on a specific work station and is clearly defined in the PN-EN 12464-1:2012 standard.

If works carried out at the machine require the colour rendering index value R_a³ 90, and the determined value is R_a < 90, then the average risk exists. Such a risk is assumed because of the losses that may arise due to incorrect colour discrimination. If the value R_a ³ 90, the risk is low (table 5).

If works carried out at the machine require the colour rendering index value R_a ³ 80, and the determined value is R_a < 80, then the average risk exists.

Detailed criteria for assessing the risk in carrying out works for which a certain value of colour rendering index R_a, is required, is presented in annex 21.4.

The colour of the light emitted by a source is determined by a colour temperature index, which is expressed in Kelvin. The colour temperature of modern light sources falls within the range of c.a. 2,700 K to 6,500 K. Sources emitting white colour light can be divided, depending on the closest colour temperature, into three groups:

• Tc ≥ 5,300 K - colour: cold, blue and white, daylight,

• 5,300 K > Tc ≥ 3,300 K - colour: indirect, neutral white, cold white,

• Tc < 3,300 K - colour: warm, red white, warm white.

A warm colour, or neutral colour temperature of light falling within the range from 2700 to 4000 K is recommended for machines lighting.

3.5 Flickering, pulsating and stroboscopic effects

Flickering lights — visual impression of instability caused by a light source whose brightness varies over time, usually due to voltage fluctuations. Above a certain threshold flickering becomes tedious. Nuisance grows very rapidly with increasing amplitude fluctuations.

Pulsating lights — regular, periodical variation in time of the luminous flux caused by a natural variation of non-interference nature of the alternating voltage supply of the light source. Pulsation frequency is twice the value of the frequency of the mains (100 Hz for Poland). The cause of pulsation is an insufficient inertia in the process of producing light by a lamp. The perception of flickering light by the sight organ occurs when the frequency of luminous flux over time is less than the so-called fading frequency (the fading frequency is the frequency of succession of images reaching the retina, above which the difference in the luminance is no longer perceived). The problem of pulsating light occurs especially when using discharge lamps, particularly fluorescent lamps. Especially dangerous situations can be caused by stroboscopic effect consisting in perceiving rotating and/or reciprocating elements of the machine as still.

Even with properly designed and constructed lighting flickering lights can be perceived; usually, it is caused by faulty or depleted light source or a failure in the stabilizing and igniting system of the light source. This phenomenon is very tiring for the eyesight and should always be eliminated.

Occupational risk assessment analysis due to the occurrence of a factor of negative impact — electrical lighting — flickering, pulsating and stroboscopic effect parameter:

- in the case of the machine lighting — consists in determining if flickering/pulsating is perceived and checking if luminaires are equipped with an anti-stroboscopic system or an electronic stabilizing and igniting system;

- in the case of facility lighting - consists in both in visual inspection if the flickering/pulsating is perceived, and in checking in the documentation of the electrical installation of the facility lighting if the luminaires are sectioned and powered from three-phases mains and equipped with an anti-stroboscopic system or an electronic stabilizing and igniting system.

Risk evaluation is carried out in accordance with annex 21.5.

3.6 Power supply

For the employee safety reasons, it is important to assess the power supply system of the local luminaire which illuminates areas inside the machine. This is particularly important in the case of powering the luminaires with mains power (230 V). Risk evaluation is carried out in accordance with annex 21.6.

3.7 Functionality of luminaires

For the employee safety reasons, it is important to assess the functionality of a luminaire mainly consisting in checking how to adjust the position of the luminaire, especially the part with the light source. Risk evaluation is carried out in accordance with annex 21.7.

4 Risk assessment results

If average or high risk has been determined for any of the lighting parameters, necessary actions to improve visual working conditions should be taken. These may involve changing the position of a luminaire in a machine or changing the source of light to a new one (e.g. of higher colour rendering index, more luminous flux), and upgrading the lighting or power supply of the luminaires — especially in the cases of high risk. The risk assessment results need to be documented in accordance with the checklist.

Risk assessment related definitions

Hazard — it is a potential source of any damage. Usually the term “hazard” is detailed and provides the origin (e.g. mechanical hazard, electrical hazard) or the nature of the potential damage (e.g. the risk of electric shock, cuts, poisoning, fire). In accordance with this definition, hazard:

· always exists with the correct use of the machine (e.g. the movement of hazardous moving parts, electric arc when welding, unhealthy posture, noise emission, high temperature), or

· can occur unexpectedly (e.g. explosion, crushing hazard due to unintended/unexpected start, ejection of a part as a result of rupture, falling as a result of acceleration/retardation).

Existing hazard — a hazard identified in the machine, i.e. present in the machine or associated with it. Hazard identification is the result of risk assessment. Existing hazards are indicated in type B and C standards.

Significant hazard — a hazard identified as existing, for which the designer is required to take special measures in order to eliminate or reduce the risk in accordance with risk assessment. Type B and C standards set out significant hazards and determine necessary safety measures.

Hazardous event — an event that can cause damage. Hazardous event can last for a short time or a long time.

Hazardous situation — a situation in which a person is exposed to at least one hazard. The hazardous situation is related to a place where there is a hazard. In order to fully determine the hazardous situation, provide the type of hazard, potential consequences, its source and location (e.g. a mechanical hazard of being caught and crushed by rotating elements of drive transmission, risk of electrical burns resulting from an electric arc in the circuits of power to the machine actuators, etc.).

Hazardous area (area of occurrence of danger, dangerous area) — any area inside and/or in the vicinity of the machine in which a person may be exposed to danger.

Damage — physical injury or deterioration of health.

Injury — damage to tissues or organs of the human body by an action of an external factor.

Risk estimation — determination of severity of a damage and likelihood of its occurrence.

Risk analysis — a combination of specified limitations related to a machine, hazard identification and risk estimation.

Risk evaluation — the judgment based on the risk analysis, whether the objectives to reduce the risk have been achieved.

Risk assessment – the overall process, which includes both risk analysis and risk evaluation.

Sufficient decrease (risk reduction) — reducing the risk to a level that — taking into account the current state of science and technology — is at least at the level required by the law.

Residual risk — the risk remaining after the application of:

· protective measures by the designer;

· any other protective measures.

Protective measure — a measure designed to reduce the risk, used by a designer and/or a user.

Task — specific action on the machine or in its vicinity, performed during its lifetime, by one or more persons.

Intended use of the machine — the use of the machine in accordance with the information concerning its operation contained in the instruction.

Foreseeable misuse — the use of the machine not as intended by the designer, which may result from an easy to predict human behaviour.

Product definition

In order to define the evaluated product, the following information needs to be collected:

· requirements for users;

· description of various phases in the machinery lifecycle;

· design drawings;

· required power supply methods and the ways of implementation;

· available documentation related to earlier design of similar machines;

· available information related to the use of the machine;

· applicable regulations, applicable standards and other documents (e.g. technical requirements, relevant safety-related provisions);

· history of accidents and non injury incidents;

· descriptions of malfunctions of the same or similar machines;

· descriptions of harmful effects of various agents emitted by machines on the health of their users;

· experience of users of similar machines or potential users of designed and manufactured machines;

· other.

Relevant aspects of use of the machines

For the purposes of risk assessment, collect the following information about the following aspects of use of the machine:

Persons subject to hazard

o operators

o other bystanders

o time of exposure

o need of access to the hazardous area (feeding/receiving the material and various objects, setting, teaching, changes or adjustments of process, cleaning, maintenance and defects finding)

o other

Necessary turning off of the operation of protective measures

o service works

o maintenance works

o other

The relationship between exposure to the risk and its consequences

o data on accidents

o experience with the use of other machines

o other

Human factor

o interpersonal relationships

o human-machine interaction

o stress

o ergonomic aspects

o awareness of the risk (depends on training, experience, skills)

o fatigue

o limitations (disability, age, illness)

o other

Usefulness of protective measures planned to be used

o slowing down production or collision with another activity or user preference

o difficult to use

o involvement of persons other than the operator

o protective measure is not recognized by the user as appropriate to fulfil its functions

o protective measure is not accepted by the user as appropriate to fulfil its functions

o other

Durability of protective measures used

o during work, protective measures may be easily maintained in good condition necessary to provide the required level of protection (a user can attempt to thwart their operation or circumvent them in order to ensure continuous operation of machines)

o other

Other

Harmonized standards and methods for risk assessment related to the essential requirements

Characteristics in accordance with items of annex I to directive 2006/42/EC	No of the Polish Standard	No of the EU Standard	Risk assessment method
Essential requirements for the protection of health and safety
General principles
Definitions	PN-EN ISO 12100:2012	EN ISO 12100:2010	Not applicable
Principles of safety integration	PN-EN ISO 12100:2012	EN ISO 12100:2010	Qualitative
Materials and products	PN-EN ISO 12100:2012	EN ISO 12100:2010	Qualitative Quantitative
Lighting	PN-EN ISO 12100:2012 PN-EN 1837+A1:2009	EN ISO 12100:2010 EN 1837:1999+A1:2009	Measurement and verification of characteristics
Design of machinery to facilitate its handling	PN-EN ISO 12100:2012	EN ISO 12100:2010	Qualitative
Ergonomics	PN-EN ISO 12100:2012 PN-EN 547-3 +A1:2010 PN-EN 614-1+A1:2009 PN-EN 614-2+A1:2010 PN-EN 894-1+A1:2010 PN-EN 894-2+A1:2010 PN-EN 894-3+A1:2010 PN-EN 894-4+A1:2010 PN-EN 1005-1+A1:2010 PN-EN 1005-2+A1:2010 PN-EN 1005-3+A1:2009 PN-EN 1005-4+A1:2009 PN-EN ISO 14738:2009 PN-EN ISO15536-1:2009 PN-EN ISO 7731: 2009	EN ISO 12100:2010 EN 547-3:1996+A1:2008 EN 614-1:2006+A1:2009 EN 614-2:2000+A1:2008 EN 894-1:1997+A1:2008 EN 894-2:1997+A1:2008 EN 894-3:2000+A1:2008 EN 894-4:2010 EN 1005-1:2001+A1:2008 EN 1005-2:2003+A1:2008 EN 1005-3:2002+A1:2008 EN 1005-4:2005+A1:2008 EN ISO 14738:2008 EN ISO 15536-1:2008 EN ISO 7731:2008	Measurement and verification of characteristics
Operating positions	PN-EN ISO 12100:2012	EN ISO 12100:2010	Qualitative
Seating	PN-EN ISO 12100:2012 PN-EN 13490:2010 EN 30326-1:2000 +A1:2008+A2:2012	EN ISO 12100:2010 EN 13490:2001+A1:2008 PN EN 30326-1:2000 +A1:2008+A2:2012	Qualitative Quantitative
Control systems
Safety and reliability of control systems	PN-EN ISO 12100:2012 PN EN ISO 13849-1:2008 PN EN ISO13849-2: 2013 PN-EN 62061:2008	EN ISO 12100:2010 EN ISO 13849-1:2008+AC:2009 EN ISO 13849-2:2012 EN 62061:2005	In accordance with EN ISO 13849-1:2008 + AC:2009
Control devices	PN-EN ISO 12100:2012 PN-EN 60204-1:2010 PN-EN 61310-3:2010	EN ISO 12100:2010 EN 60204-1:2006+A1:2009 EN 61310-3:2008	Verification of properties
Starting	PN-EN ISO 12100:2012 PN-EN ISO 13849-1:2008 PN-EN 60204-1:2010 PN-EN 1037 +A1:2010	EN ISO 12100:2010 EN ISO 13849-1:2008 EN 60204-1:2006+A1:2009 EN 1037:1995+A1:2008	In accordance with EN ISO 13849-1:2008 + AC:2009
Stopping
Normal stop	PN-EN ISO 12100:2012 PN-EN ISO 13849-1:2008 PN-EN 60204-1:2010	EN ISO 12100:2010 EN ISO 13849-1:2008 EN 60204-1:2006+A1:2009	In accordance with EN ISO 13849-1:2008 + AC:2009
Operational stop	PN-EN ISO 12100:2012	EN ISO 12100:2010	In accordance with EN ISO 13849-1:2008 + AC:2009
Emergency stop	PN-EN ISO 12100:2012 PN-EN ISO 13849-1:2008 PN-EN 60204-1:2010 PN-EN ISO 13850:2012	EN ISO 12100:2010 EN ISO 13849-1:2008 EN 60204-1:2006+A1:2009 EN ISO 13850:2008	In accordance with EN ISO EN ISO 13850:2008
Assembly of machinery	PN-EN ISO 12100:2012	EN ISO 12100:2010	Qualitative
Selection of control or operating modes	PN-EN ISO 12100:2012 PN-EN 60204-1:2010	EN ISO 12100:2010 EN 60204-1:2006+A1:2009	In accordance with EN ISO 13849-1:2008 + AC:2009
Failure of the power supply	PN-EN ISO 12100:2012 PN- PN-EN 60204-1:2010 PN-EN ISO 13849-1:2008	EN ISO 12100:2010 EN 60204-1:2006+A1:2009 EN ISO 13849-1:2008	In accordance with EN ISO 13849-1:2008 + AC:2009
Protection against mechanical hazards
Risk of loss of stability	PN-EN ISO12100:2012	EN ISO 12100:2010	Qualitative
Risk of break-up during operation	PN-EN ISO12100:2012	EN ISO 12100:2010	Qualitative
Risks due to falling or ejected objects	PN-EN ISO 12100:2012	EN ISO 12100:2010	Qualitative
Risks due to surfaces, edges or angles	PN-EN ISO 12100:2012	EN ISO 12100:2010	Qualitative
Risks related to combined machinery	PN-EN ISO 12100:2012 PN EN ISO 11161: 2007 +A1:2010	EN ISO 12100:2010 EN ISO 11161:2007 +A1:2010	Qualitative
Risks related to variations in operating conditions	PN-EN ISO 12100:2012 PN-EN ISO 13849-1:2008	EN ISO 12100:2010 EN ISO 13849-1:2008	Qualitative
Risks related to moving parts	PN-EN ISO 12100:2012	EN ISO 12100:2010	Qualitative
Choice of protection against risks arising from moving parts	PN-EN ISO 12100:2012 PN-EN 349+A1:2010 PN-EN 547-1+A1:2010 PN-EN 547-2+A1:2010	EN ISO 12100:2010 EN 349:1993+A1:2008 EN 547-1:1996+A1:2008 EN 547-2:1996+A1:2008	Qualitative
Moving transmission parts	PN-EN ISO 12100:2012 PN-EN 349+A1:2010 PN-EN 547-1+A1:2010 PN-EN 547-2+A1:2010	EN ISO 12100:2010 EN 349:1993+A1:2008 EN 547-1:1996+A1:2008 EN 547-2:1996+A1:2008	Qualitative
Moving parts involved in the process	PN-EN ISO 12100:2012 PN-EN 349+A1:2010 PN-EN 547-1+A1:2010 PN-EN 547-2+A1:2010	EN ISO 12100:2010 EN 349:1993+A1:2008 EN 547-1:1996+A1:2008 EN 547-2:1996+A1:2008	Qualitative
Risk related to uncontrolled movements	PN-EN ISO 12100:2012	EN ISO 12100:2010	Qualitative
Required characteristics of guards and protective devices
General requirements	PN-EN ISO 12100:2012	EN ISO 12100:2010	Qualitative
Special requirements for guards
Fixed guards	PN-EN 12100:2012 PN-EN 953+A1:2009 PN-EN 60529:2003 PN-EN ISO 13857:2010 PN-EN 349+A1:2010 PN-EN 547-1+A1:2010 PN-EN 547-2+A1:2010	EN ISO 12100:2010 EN 953:1997+A1:2009 EN 60529:1991 EN ISO 13857:2008 EN 349:1993+A1:2008 EN 547-1:1996+A1:2008 EN 547-2:1996+A1:2008	Qualitative
Interlocking movable guards	PN-EN 12100:2012 PN-EN 953+A1:2009 PN-EN ISO 13857:2010 PN-EN 349+A1:2010 PN-EN 547-1+A1:2010 PN-EN 547-2+A1:2010	EN ISO 12100:2010 EN 953:1997+A1:2009 EN ISO 13857:2008 EN 349:1993+A1:2008 EN 547-1:1996+A1:2008 EN 547-2:1996+A1:2008	Qualitative
Adjustable guards restricting access	PN-EN 12100:2012 PN-EN 953+A1:2009 PN-EN 60529:2003 PN-EN ISO 13857:2010 PN-EN 349+A1:2010 PN-EN 547-1+A1:2010 PN-EN 547-2+A1:2010	EN ISO 12100:2010 EN 953:1997+A1:2009 EN 60529:1991 EN ISO 13857:2008 EN 349:1993+A1:2008 EN 547-1:1996+A1:2008 EN 547-2:1996+A1:2008	Qualitative
Special requirements for protective devices	PN-EN 12100:2012 PN-EN 61496-1:2014 PN-EN ISO 13855:2010	EN ISO 12100:2010 EN 61496-1:2013 EN ISO 13855:2010	In accordance with EN 61496-1:2013
Risks due to other hazards
Electricity supply	PN-EN 12100:2012 PN-EN 60204-1:2010 PN-EN 60529:2003	EN ISO 12100:2010 EN 60204-1:2006+A1:2009 EN 60529:1991	In accordance with EN 60204-1:2006+A1:2009
Static electricity	PN-EN 12100:2012	EN ISO 12100:2010	In accordance with EN 60204-1:2006+A1:2009
Energy supply other than electricity	PN-EN 12100:2012 PN-EN ISO 4414:2011 PN EN ISO 4413:2011	EN ISO 12100:2010 EN ISO 4414:2010 EN ISO 4413:2010	Qualitative
Errors of fitting	PN-EN 12100:2012	EN ISO 12100:2010	Qualitative
Extreme temperatures	PN-EN 12100:2012 PN EN ISO13732-3:2009 PN EN ISO 13732-1: 2009	EN ISO 12100:2010 EN ISO 13732-3:2008 EN ISO 13732-1:2008	Qualitative
Fire	PN-EN 12100:2012 PN-EN 13478+A1: 2008	EN ISO 12100:2010 EN 13478:2001+A1:2008	Qualitative
Explosion	PN-EN 12100:2012 PN-EN 1127-1:2011 PN-EN 15967: 2011	EN ISO 12100:2010 EN 1127-1:2011 EN 15967:2011	Qualitative
Noise	PN-EN 12100:2012 PN-EN ISO 3741: 2011 PN-EN ISO 3743-1:2011 PN-EN ISO 3743-2:2010 PN-EN ISO 3744:2011 PN-EN ISO 3745: 2012 PN-EN ISO 3746:2011 PN-EN ISO 3747: 2011 PN-EN ISO 4871:2012 PN-EN ISO 5136: 2009 PN-EN ISO 7235: 2009 PN-EN ISO 9614-1: 2010 PN-EN ISO 9614-3: 2010 PN-EN ISO 11200: 2011 PN-EN ISO 11201:2012 PN-EN ISO 11202: 2012 PN-EN ISO 11203: 2010 PN-EN ISO 11204: 2010 PN-EN ISO 11205:2010: PN-EN ISO 11546-1: 2010 PN-EN ISO 11546-2: 2010 PN-EN ISO 11554: 2010 PN-EN ISO 11688-1: 2010 PN-EN ISO 11691: 2009 PN-EN ISO 11957: 2010	EN ISO 12100:2010 EN ISO 3741:2010 EN ISO 3743-1:2010 EN ISO 3743-2:2009 EN ISO 3744:2010 EN ISO 3745:2012 EN ISO 3746:2010 EN ISO 3747:2010 EN ISO 4871:2009 EN ISO 5136:2009 EN ISO 7235:2009 EN ISO 9614-1:2009 EN ISO 9614-3:2009 EN ISO 11200:2009 EN ISO 11201: 2010 EN ISO 11202:2010 EN ISO 11203:2009 EN ISO 11204:2010 EN ISO 11205:2009 EN ISO 11546-1:2009 EN ISO 11546-2:2009 EN ISO 11554:2008 EN ISO 11688-1:2009 EN ISO 11691:2009 EN ISO 11957:2009	Quantitative
Vibrations	PN-EN 12100:2012 PN-EN 1032+A1:2010 PN-EN 1299+A1:2010 PN-EN 1299+A1:2010 PN EN ISO 20643: 2009+A1:2012 PN EN 30326-1:2000 +A1:2008+A2:2012	EN ISO 12100:2010 EN 1032:2003+A1:2008 EN 1299:1997+A1:2008 EN 1299:1997+A1:2008 EN ISO 20643:2008+ A1:2012 EN 30326-1:1994+A1:2007 +A2:2011	Quantitative
Radiation	PN-EN 12100:2012 PN-EN 12198-1+A1:2010 PN-EN 12198-2+A1:2010 PN-EN 12198-3+A1:2010	EN ISO 12100:2011 EN 12198-1:2000+A1:2008 EN 12198-2:2002+A1:2008 EN 12198-3:2002+A1:2008	Quantitative
External radiation	PN-EN 12100:2012	EN ISO 12100:2010	Quantitative
Laser radiation	PN-EN 12100:2012 PN EN ISO 11145:2010 PN-EN 12254: 2011	EN ISO 12100:2010 EN ISO 11145:2008 EN 12254:2010+AC:2011	Quantitative
Emissions of hazardous materials and substances	PN-EN 12100:2012 PN-EN 626-1+A1:2010 PN-EN 626-2 +A1:2010 PN-EN1093-1: 2009 PN-EN1093-2 +A1:2008 PN-EN1093-3 +A1:2008 PN-EN1093-4 A1:2010 PN-EN1093-6+A1:2010 PN-EN1093-7+A1:2010 PN-EN1093-8+A1:2010 PN-EN1093-9 A1:2010 PN-EN1093-11 A1:2010	EN ISO 12100:2010 EN 626-1:1994+A1:2008 EN 626-2:1996+A1:2008 EN 1093-1:2008 EN 1093-2:2006+A1:2008 EN 1093-3:2006+A1:2008 EN 1093-4:1996+A1:2008 EN 1093-6:1998+A1:2008 EN 1093-7:1998+A1:2008 EN 1093-8:1998+A1:2008 EN 1093-9:1998+A1:2008 EN 1093-11:2001+A1:2008	Quantitative
Risk of being trapped in a machine	PN-EN 12100:2012	EN ISO 12100:2010	Qualitative
Risk of slipping, tripping or falling	PN-EN 12100:2012	EN ISO 12100:2010	Qualitative
Maintenance
Machinery maintenance	PN-EN ISO 12100:2012	EN ISO 12100:2010	Qualitative
Access to operating positions and servicing points	PN-EN ISO 12100:2012 PN-EN ISO14122-1:2005+A1:2010 PN-EN ISO14122-2:2005+A1:2010 PN-EN ISO14122-3:2005+A1:2010	EN ISO 12100:2010 EN ISO 14122-1:2001 EN ISO 14122-2:2001+A1:2010 EN ISO 14122-3:2001+A1:2010	Qualitative
Isolation of energy sources	PN-EN ISO 12100:2012	EN ISO 12100:2010	In accordance with EN 60204-1:2006+A1:2009
Operator intervention	PN-EN ISO 12100:2012	EN ISO 12100:2010	Qualitative
Cleaning of internal parts	PN-EN ISO 12100:2012	EN ISO 12100:2010	Qualitative
Information
Information and warnings on the machinery	PN-EN ISO 12100:2012 PN-EN 61310-2:2010	EN ISO 12100:2010 EN 61310-2:2008	Qualitative
Information and information devices	PN-EN ISO 12100:2012 PN-EN 60204-1:2010 PN-EN 61310-1:2010 PN-EN 61310-2:2010 PN-EN 61310-3:2010	EN ISO 12100:2010 EN 60204-1:2006+A1:2009 EN 61310-1:2008 EN 61310-2:2008 EN 61310-3:2008	Qualitative
Warning devices	PN-EN ISO 12100:2012 PN-EN 60204-1:2010 PN-EN 61310-1:2010 PN EN 842+A1:2010 PN EN 981+A1:2010	EN ISO 12100:2010 EN 60204-1:2006+A1:2009 EN 61310-1:2008 EN 842:1996+A1:2008 EN 981:1996+A1:2008	Qualitative
Warning of residual risks	PN-EN ISO 12100:2012	EN ISO 12100:2010	Qualitative
Marking of machinery	PN-EN ISO 12100:2012 PN-EN 60204-1:2010	EN ISO 12100:2010 EN 60204-1:2006+A1:2009	Qualitative
Instructions	PN-EN ISO 12100:2012 PN-EN 60204-1:2010	EN ISO 12100:2010 EN 60204-1:2006+A1:2009	Qualitative
General principles for the drafting of instructions	PN-EN ISO 12100:2012 PN-EN 60204-1:2010	EN ISO 12100:2010 EN 60204-1:2006+A1:2009	Qualitative
Contents of the instructions	PN-EN ISO 12100:2012 PN-EN 60204-1:2010	EN ISO 12100:2010 EN 60204-1:2006+A1:2009	Qualitative

Examples of tasks which may be related to hazardous situations

Transportation → tasks (potentially hazardous situations)

o lifting

o loading

o packing

o transportation

o unloading

o unpacking

o other

Assembly, installation and commissioning → tasks (potentially hazardous situations)

o setup of the machine and its components, and assembly of the machine

o connection to the discharge system (e.g. exhaust ventilation system, septic system)

o connection to the power supply system (e.g. electricity supply, compressed air supply)

o demonstration of the machine

o feeding the material or objects

o filling in

o addition of auxiliary liquids (e.g. oil, grease, glue)

o fencing

o fixing

o anchoring

o preparing to installation (e.g. foundation, vibration dampers)

o operation of the machine with no load

o tests

o tests with load or maximum load

o other

Adjusting, teaching, programming and/or change of the process of the machine → tasks (potentially hazardous situations)

o adjustment and setting of the protective devices and other components

o adjustment and setting or checking of functional parameters of the machine (e.g. speed, pressure, force, movement boundaries)

o fixing workpieces, feeding

o filling, placing the raw material

o testing functional parameters

o tests, fixing or replacing tools

o setting up tools

o testing the software

o checking the machine

o other

Operation of the machine → tasks (potentially hazardous situations)

o fixing workpieces

o check/inspection

o starting the drive

o riding the machine

o feeding

o filling in

o placing the raw material

o manual feeding/receiving

o minor adjustments and setting of the functional parameters of the machine (e.g. speed, pressure, force, movement boundaries)

o minor adjustments during operation (e.g. removal of waste, eliminating jams, local cleaning)

o operating manual control actuators

o restarting the machine after stop/break in operation

o supervising and checking the machine

o other

Cleaning and maintenance of the machine → tasks (potentially hazardous situations)

o adjustments

o cleaning

o disinfecting

o disassembly/removal of parts, components, elements of the machine devices

o ongoing cleanliness and order

o disconnection of power supply and energy dissipation

o oiling and lubricating

o replacing tools

o replacing worn parts

o resetting (re-adjusting)

o replacing fluids to the appropriate level

o checking parts, components, elements of the machine devices

o other

Fault detection and troubleshooting of the machine → tasks (potentially hazardous situations)

o adjustments

o disassembly/removal of parts, components, elements of the machine devices

o detecting faults

o disconnection of power supply and energy dissipation

o restoring normal state after the removal of faults in the control system and protective devices

o restoring normal state after the removal of jams

o repairing and replacing parts, components, elements of the machine devices

o releasing and rescuing trapped people

o resetting (re-adjusting)

o checking parts, components, elements of the machine devices

o other

Decommissioning and deinstallation of the machine → tasks (potentially hazardous situations)

o disconnection of power supply and energy dissipation

o disassembly

o lifting

o loading

o packing

o transportation

o unloading

o other

Other phases of use of the task (potentially hazardous situations)

Hazard: sources and potential consequences

Hazards (sources and potential consequences of hazards) should be identified using the following list. Hazards should be determined for all tasks (hazardous situations) identified for all phases of machine use.

Mechanical → sources

· acceleration

· retardation

· parts with sharp edges

· approach of a moving element to a fixed part

· cutting parts

· elastic parts

· falling objects

· gravitational force

· height from the ground level

· high pressure

· lack of stability

· kinetic energy

· mobility of machines

· moving elements

· rotating elements

· uneven surface

· slippery surface

· sharp edges

· accumulated energy

· vacuum

· other

Mechanical → potential consequences of hazards

· being run over

· being thrown

· crushing

· cutting or cutting off

· being pulled into or seized

· entanglement

· abrasion

· hit

· injection

· ejection

· cutting

· slipping

· tripping and falling

· puncture

· perforation

· suffocation

· other

Electrical → source

· electric arc

· electromagnetic phenomena

· electrostatic phenomena

· live parts

· insufficient distance form live parts under high voltage

· overvoltage

· parts which became live due to a fault

· electrical short circuit

· heat radiation

· other

Electrical → potential consequences of hazards

· burns

· chemical effects

· effects related to medical implants

· electric shock

· falling

· being thrown

· fire

· ejection of molten parts

· concussion

· shock

· other

Thermal → sources

· explosion

· flame

· high or low temperature of objects or materials

· radiation from heat sources

· other

Thermal → potential consequences of hazards

· burns

· dehydration

· discomfort

· frostbite

· injuries resulting from the radiation from heat sources

· burns

· other

Noise → sources

· cavitation phenomenon

· exhaust system

· gas flow at high speed

· production process (pressing, cutting, etc.)

· moving parts

· scrapping the surface

· unbalanced rotating parts

· noisy pneumatic systems

· worn parts

· other

Noise → potential consequences of hazards

· Discomfort

· loss of consciousness

· loss of balance

· permanent hearing impairment

· stress

· hum in ears

· fatigue

· others (e.g. mechanical, electrical) resulting from interference in oral communication or audible signalling

· other

Mechanical vibrations → sources

· cavitation phenomenon

· misalignment of moving parts

· movable equipment

· scrapping the surface

· unbalanced rotating parts

· vibratory equipment

· worn parts

· other

Mechanical vibration → potential consequences of hazards

· discomfort

· diseases around the loins

· neurological diseases

· bone and joint diseases

· spine injuries

· vascular diseases

· other

Radiation → sources

· source of ionizing radiation

· low frequency electromagnetic radiation

· optical radiation (infrared, visible and ultraviolet light, and laser)

· radio frequency electromagnetic radiation

· other

Radiation → potential consequences of hazards

· burns

· injuries to the eyes and skin injuries

· negative impact on reproduction

· genetic mutations

· headache

· insomnia

· other

Materials and substances → sources

· aerosols

· biological and microbiological agents (viruses or bacteria)

· combustible materials

· dust

· explosive materials

· fibre

· combustible materials

· fluids

· fumes

· exhaust gases

· vapours

· gases

· fog

· oxidants

· other

Materials and substances → potential consequences of hazards

· difficulty in breathing

· choking

· cancer

· corrosion

· negative impact on reproduction

· explosion

· fire

· infection

· mutation

· poisoning

· allergy

· other

Non-observance of ergonomics principles → sources

· access

· construction or location of indicators and monitors

· design, location or recognition of the control devices

· effort

· mental overload or underload

· unhealthy posture

· repeatable activities

· visibility

· other

Non-observance of ergonomics principles → potential consequences of hazards

· discomfort

· fatigue

· disorders of the musculoskeletal system

· stress

· other consequences (e.g. mechanical, electrical) resulting from human error

· other

Machine’s work environment → sources

· dust and fog

· electromagnetic interferences

· atmospheric discharges

· humidity

· environment pollution

· snow

· temperature

· water

· wind

· lack of oxygen

· other

Machine’s work environment → potential consequences of hazards

· burns

· mild ailments

· slipping

· falling

· choking

· other resulting from effects caused by hazard sources related to machines or their parts

· other

Combination of hazards → sources

· repetitive actions and exertion combined with high ambient temperatures

· other

Combination of hazards → potential consequences of hazards

· dehydration and loss of consciousness, and heatstroke

· other

Hazardous events

source of risk associated with the shape and/or finishing of the surfaces of accessible parts of the machines

Hazardous events:

o touching rough surfaces

o touching sharp edges and corners

o touching protruding parts

o other

source of risk associated with moving parts of the machine

Hazardous events:

o touching moving parts

o touching exposed ends of rotating parts

o other

source of risk associated with kinetic and/or potential (gravity) energy of the machine, its parts, tools and materials used, processed or moved

Hazardous events:

o falling objects

o ejection of objects

o other

source of risks associated with the stability of the machine

Hazardous events:

o loss of stability

o other

source of risk associated with mechanical strength of machine parts and tools

Hazardous events:

o damage during operation

o other

source of risk associated with pneumatic and hydraulic equipment of the machine

Hazardous events:

o change of position (moving) of moving parts

o ejection of liquids under high pressure

o uncontrolled movements

o other

source of risk associated with electrical equipment of the machine

Hazardous events:

o direct access

o complete discharge

o electric arc

o fire

o indirect access

o short circuit

o other

source of risk associated with the control system of the machine

Hazardous events:

o fall or ejection of moving part of the machine or the workpiece

o inability to stop a moving part

o operation of the machine resulting from stopping the operation of protective devices (thwarting action or failure)

o uncontrolled movements (including speed change)

o unintended/unexpected start-up of the machine

o other dangerous events resulting from damage or improper design of the control system

o other

source of risk associated with materials and substances or physical factors

Hazardous events:

o touching objects of high or low temperature

o emissions of substances that may be harmful

o emission of noise levels that may be harmful

o emission of noise levels that may cause disturbances in oral communication or audible signalling

o emission of mechanical vibration at levels that may be harmful

o emissions of radiation that can be harmful, harsh environmental conditions

o other

source of risks associated with the design of work station and/or work process

Hazardous events:

o overexertion

o human error / improper behaviour (unintentional and/or intentional, resulting from design solutions)

o loss of sight of the working area, the positions of the body that cause pain and fatigue

o frequent repetitive actions

o other

Qualitative risk estimation

Estimate the risk elements: the severity of damage and the probability of its occurrence, taking into account the aspects taken into consideration in the case of evaluation. Estimate the risk taking into account the estimated risk elements.

1. Severity of the damage

Aspects taken into consideration in the case of evaluation:

Estimating the severity of injury or health deterioration:

o minor

o fatal

o severe

Estimating the severity of the damage

o one person

o many people

Example of the estimate of the severity of the damage

o high

o average

o low

2. Probability of the occurrence of damage

Aspects taken into consideration in the case of evaluation:

Exposure of people to danger

o need for access to the hazardous area

o access nature

o the time of presence in the hazardous area

o access frequency

o other

Hazardous event occurrence

o historical data

o statistical data

o reliability data

o other

Technical and human possibilities to avoid or mitigate the damage

o knowledge of operators

o experience and skills of operators

o individual possibility of avoiding or reducing damage

o warning signals sent before the hazardous event

o the rate of occurrence of damage by a specific hazardous situation

o other

An example of the estimate of the probability of damage

o high

o average

o low

3. An example of matrix for qualitative risk evaluation

		Probability of the occurrence of damage
		low	average	high
Severity of the damage	low	low risk	low risk	average risk
	average	low risk	average risk	high risk
	high	average risk	high risk	high risk

Quantitative risk estimation

Estimate the risk taking into account the results of measurement of the measurable factors emitted by the machine.

In the case of the risks posed by measurable factors, to determine the severity of consequences, the risk can be evaluated in accordance with table 1.

Table 1. Example of estimating occupational risks associated with emission by the machine of measurable factors

Value defining exposure	Occupational risk evaluation
P > P_max	HIGH
P_max≥ P ≥ 0.5 P_max	AVERAGE
P < 0.5 P_max	LOW

P_max is the exposure limit value generally determined based on relevant standards and directives, and if they are missing, based on the comparison with commercially available similar machines. Such factors may include vibration, noise, emitted chemical substances.

In the case of noise and vibration, the manufacturer does not specify acceptable risk associated with these factors. In accordance with regulation on essential requirements for machines, the manufacturer is required to provide only information about the emission only if certain values are exceeded, or inform that these values are not exceeded.

Evaluation of risk — risk acceptability criteria

Evaluate the risk taking into account the following criteria:

o all types of work and all ways of user interaction taken into account

o all hazards eliminated or risks caused by them reduced to the lowest level possible in practice

o all new hazards that have emerged along with the protective measures were properly demonstrated and appropriate protective measures were used,

o users have been fully informed and warned of the residual risks

o adopted protective measures are compatible

o consequences that may arise for the risk resulting from the machine’s design for professional or industrial use have been reasonably taken into account,

o protective measures taken do not adversely affect the working conditions of the operator or the usefulness of the machine

Risk evaluation — comparison with other similar machinery

Evaluate the risk taking into account the following criteria for other similar machinery:

o meeting the type C standard (standards) requirements

o misuse and intended use

o design and construction

o hazards and risk elements

o technical requirements

o use conditions and differences

o other