Instructions for Use for Machinery: Content, Safety, and Checklist
Instructions for use must assist personnel in operating machinery safely and in accordance with its intended use. This information must also remain applicable and accessible when the machinery is transported, installed, maintained, and ultimately decommissioned. Consequently, drafting should begin by analyzing the machinery and the persons who will be operating it.
What tasks are to be performed? Who will perform them? What information does that person require to understand the machinery's functions, residual risks, and protective measures? An operator, installation technician, and service engineer may require different instructions for the same machinery.
In Noex, you can use a predefined chapter structure to develop your instructions for use step-by-step.
Safety is Paramount
Use the machinery's risk assessment as the foundation when planning the content. Address the hazards associated with the intended use as well as reasonably foreseeable misuse. Furthermore, identify the residual risks that remain after protective measures have been implemented.
We recommend dedicating a separate safety chapter to general safety information. This provides the reader with a consolidated overview of residual risks, protective measures, safety signs, and emergency procedures. Noex’s predefined structure includes such a chapter.
Task-specific information must also be integrated directly within the description of that task. If specific protective equipment is required during cleaning, this must be stated where the cleaning procedure is described. The operator must be able to read the instructions and understand how to perform the work safely.
Write in concrete terms. Describe the situation, the hazard, and the action the user must take. Verify that warnings, illustrations, and nomenclature correspond precisely to the specific machinery to which the instructions for use apply.
Use the Checklist While Drafting
A heading merely indicates where information may be located; it does not guarantee that the content is sufficient. You should therefore review the checklist continuously throughout the drafting process. For each item, you must determine its applicability and verify that the required information is actually included in the instructions.
In Noex, the checklist is integrated into the writing support tool. From a checkpoint, the user can navigate directly to the corresponding section of the instructions.
Assess which requirements are applicable to the machinery in question and maintain an overview of completed sections and outstanding tasks.
A checkpoint can be marked as not started, completed, or not applicable.
In Which Languages Must the Instructions Be Provided?
For machinery placed on the market, put into service, or distributed for the first time in an EU Member State, the instructions for use must, under current local machinery regulations, be provided in the local language. If the instructions are a translation, they must be marked "Translation of the original instructions", and the original instructions must accompany them. Under the Machinery Regulation, the instructions for use must be provided in a language easily understood by users, as determined by the Member State concerned. The Regulation will apply from 20 January 2027.
What Changes from the Machinery Directive to the Machinery Regulation?
The national regulations implementing the Machinery Directive 2006/42/EC remain in force until 20 January 2027, when the EU Machinery Regulation (EU) 2023/1230 begins to apply and repeals the Machinery Directive. Both frameworks specify in section 1.7.4.2 the minimum information that the instructions for use must contain, where applicable. Naturally, the Noex manual generator provides these legal requirements as an interactive checklist while you draft your instructions.
Below is a summary of the key differences:
Area | Difference in the Legislative Texts |
|---|---|
Products | The Directive refers to the machinery. The Regulation refers in several points to the machinery or related product. |
Manufacturer Details | The Directive requires the name and address of both the manufacturer and their authorised representative. The Regulation requires the manufacturer's business name and full address and, where applicable, their authorised representative. |
Declaration of Conformity | The Directive requires the EC Declaration of Conformity or a document setting out its contents. The Regulation requires the EU Declaration of Conformity, or the internet address or machine-readable code where it can be accessed in accordance with Article 10(8). |
Adjustment and Maintenance | The wording in point (r) has been amended. The Regulation specifies that the description must take into account the design and use of the product. |
Noise | Point (u) of the Regulation also mentions common specifications in the provision regarding the measurement method. It also includes a provision on assembly and installation instructions for noise-reducing machinery or related products. |
Rescue of Persons | Point (v) of the Regulation specifies information on the necessary precautions, devices, and means for immediate and gentle rescue. |
Non-ionizing Radiation | The requirement is present in both texts: point (v) in the Directive and point (w) in the Regulation. |
Emissions of Hazardous Substances | Point (x) of the Regulation includes details regarding containment, filtration, or discharge devices, as well as the specified options for information on emissions. |
What Must the Instructions Contain - and How Must They Be Delivered?
These are two separate issues under the Machinery Regulation. Annex III, section 1.7.4.2, defines the minimum information that the instructions must contain where applicable (e.g., intended use, residual risks, and maintenance instructions). Article 10(7) governs how the instructions must be provided. They may be provided in digital format, but the user must be informed how to access them, and must be able to print, download, and save them. Consequently, instructions can have the correct content without meeting the delivery requirements of Article 10(7) - and vice versa. Manufacturers must comply with both aspects.
Source: Machinery Regulation (EU) 2023/1230, Article 10(7) and Annex III, section 1.7.4.2.
Checklist: Content of the Instructions for Use
The checklist below is Noex's thematic checklist based on the referenced legislative texts. It is not a literal reproduction of the legislation. Verify which regulatory framework applies to your machinery and consult the detailed provisions in the Machinery Directive or the Machinery Regulation.
Manufacturer and Identification
The Machinery Directive requires the name and full address of both the manufacturer and their authorised representative. The Machinery Regulation requires the manufacturer's business name and full address and, where applicable, their authorised representative.
Name/business name and full address of the manufacturer
The manufacturer's authorised representative in accordance with the above requirements
Designation of the machinery or related product as marked on the product itself, excluding the serial number
Declaration of Conformity
The Machinery Directive requires the EC Declaration of Conformity, or a document setting out the contents of the EC Declaration of Conformity, showing the particulars of the machinery, not necessarily including the serial number and the signature.
The Machinery Regulation requires the EU Declaration of Conformity, or the internet address or machine-readable code where the EU Declaration of Conformity can be accessed, in accordance with Article 10(8).
Declaration of Conformity or the alternative information/access specified in the applicable regulatory framework
Description of the Machinery
A general description of the machinery or related product
The drawings, diagrams, descriptions and explanations necessary for the operation, maintenance and repair of the machinery or related product and for checking its correct functioning
A description of the workstation(s) likely to be occupied by operators
A description of the intended use of the machinery or related product
Warnings concerning ways in which the machinery or related product must not be used that experience has shown might occur
Assembly, Installation, and Commissioning
Assembly, installation and connection instructions, including drawings, diagrams and the means of attachment and the designation of the chassis or installation on which the machinery or related product is to be mounted
Instructions relating to installation and assembly for reducing noise or vibration
Instructions for assembly, commissioning and use and, if necessary, instructions for the training of operators
Residual Risks and Protective Measures
Information on the residual risks that remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted
Instructions on the protective measures to be taken by the user, including, where appropriate, the personal protective equipment to be provided
Tools
The essential characteristics of tools which may be fitted to the machinery or related product
Stability
The conditions under which the machinery or related product meets the requirement of stability during use, transportation, assembly, dismantling, when out of service, testing or foreseeable breakdowns
Transport, Handling, and Storage
Instructions with a view to ensuring that transport, handling and storage operations can be made safely, giving the mass of the machinery or related product and of its various parts where these are regularly to be transported separately
Accidents, Breakdowns, and Blockages
The operating method to be followed in the event of accident or breakdown
If a blockage is likely to occur, the operating method to be followed to enable the blockage to be safely cleared
Adjustment and Maintenance
The Machinery Directive requires a description of the adjustment and maintenance operations to be carried out by the user and the preventive maintenance measures that should be observed.
The Machinery Regulation requires a description of the adjustment and maintenance operations to be carried out by the user and the preventive maintenance measures that should be observed, taking into account the design and use of the machinery or related product.
Adjustment and maintenance operations to be carried out by the user, and preventive maintenance measures, in accordance with the above requirements
Instructions designed to enable adjustment and maintenance to be carried out safely, including the protective measures that should be taken during these operations
Specifications of the spare parts to be used, when these affect the health and safety of operators
Noise Emission
The A-weighted emission sound pressure level at workstations, where this exceeds 70 dB(A)
Where this level does not exceed 70 dB(A), this fact must be indicated
The peak C-weighted instantaneous sound pressure value at workstations, where this exceeds 63 Pa (130 dB in relation to 20 μPa)
The A-weighted sound power level from the machinery or related product, where the A-weighted emission sound pressure level at workstations exceeds 80 dB(A)
Noise values which are either actually measured for the machinery or related product concerned, or established on the basis of measurements made on technically comparable machinery or related products
In the case of very large machinery or related products, the A-weighted emission sound pressure levels at specified positions around the machinery, if this is specified instead of the A-weighted sound power level
Measurement Method for Noise
The Machinery Directive specifies that where harmonised standards are not applied, sound levels must be measured using the most appropriate method for the machinery.
The Machinery Regulation specifies that where harmonised standards or common specifications adopted by the Commission in accordance with Article 20(3) cannot be applied, sound levels must be measured using the most appropriate method for the machinery or related product.
Sound levels measured in accordance with the above requirements
The uncertainty surrounding the specified noise values must be indicated
The operating conditions of the machinery or related product during measurement must be specified
The measurement methods used must be indicated
Where workstations are undefined or cannot be defined, A-weighted sound pressure levels must be measured at a distance of 1 metre from the surface of the machinery or related product and at a height of 1.6 metres from the floor or access platform
The position and value of the maximum sound pressure must be indicated
Where specific Union legal acts lay down other requirements for the measurement of sound pressure levels or sound power levels, those legal acts must be applied, as specified in the Machinery Regulation. The Directive refers here to specific Community Directives.
Noise-Reducing Equipment in Machinery or Related Products
The Machinery Regulation states that the instructions for use must, where appropriate, specify how to correctly assemble and install noise-reducing equipment.
Where appropriate, information on how to correctly assemble and install noise-reducing equipment
Rescue of Persons
Point (v) of the Machinery Regulation specifies the following information:
Information on the necessary precautions, devices, and means for immediate and gentle rescue of persons
Non-ionizing Radiation
This point is included in both frameworks: as point (v) in the Machinery Directive and point (w) in the Machinery Regulation.
Information on the radiation emitted to the operator and exposed persons, where the machinery or related product is likely to emit non-ionising radiation which may cause harm to persons, in particular persons with active or non-active implantable medical devices
Emissions of Hazardous Substances
Point (x) of the Machinery Regulation specifies information where the design of the machinery or related product allows for emissions of hazardous substances.
The characteristics of the containment, filtration or discharge device where such a device is not supplied with the machinery or related product
Any of the following:
The flow rate for emissions of hazardous materials and substances from the machinery or related product
The concentration of hazardous materials or substances around the machinery or related product coming from the machinery or related product or from materials or substances used with the machinery or related product
The effectiveness of the containment or filtration device and the conditions to be observed to maintain its effectiveness over time
Furthermore, for the values specified:
The values must be actually measured for the machinery or related product concerned
or
The values must be established on the basis of measurements made on a technically comparable machinery or related product which is representative of the state of the art
Review the Completed Instructions for Use
Read the instructions as if you were performing the tasks for the first time. Can you clearly identify the correct machinery? Can you locate the relevant instruction when required? Are the hazards and the procedures to follow in the event of a breakdown or blockage clearly described? Do drawings, values, and designations correspond precisely to the machinery to be delivered?
Reproduction from Machinery Directive Annex 1 - 1.7.4.2
1.7.4.2. Contents of the instructions
Each instruction manual must contain, where applicable, at least the following information:
(a) the business name and full address of the manufacturer and of his authorised representative;
(b) the designation of the machinery as marked on the machinery itself, except for the serial number (see section 1.7.3);
(c) the EC declaration of conformity, or a document setting out the contents of the EC declaration of conformity, showing the particulars of the machinery, not necessarily including the serial number and the signature;
(d) a general description of the machinery;
(e) the drawings, diagrams, descriptions and explanations necessary for the use, maintenance and repair of the machinery and for checking its correct functioning;
(f) a description of the workstation(s) likely to be occupied by operators;
(g) a description of the intended use of the machinery;
(h) warnings concerning ways in which the machinery must not be used that experience has shown might occur;
(i) assembly, installation and connection instructions, including drawings, diagrams and the means of attachment and the designation of the chassis or installation on which the machinery is to be mounted;
(j) instructions relating to installation and assembly for reducing noise or vibration;
(k) instructions for the putting into service and use of the machinery and, if necessary, instructions for the training of operators;
(l) information about the residual risks that remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted;
(m) instructions on the protective measures to be taken by the user, including, where appropriate, the personal protective equipment to be provided;
(n) the essential characteristics of tools which may be fitted to the machinery;
(o) the conditions in which the machinery meets the requirement of stability during use, transportation, assembly, dismantling when out of service, testing or foreseeable breakdowns;
(p) instructions with a view to ensuring that transport, handling and storage operations can be made safely, giving the mass of the machinery and of its various parts where these are regularly to be transported separately;
(q) the operating method to be followed in the event of accident or breakdown; if a blockage is likely to occur, the operating method to be followed so as to enable the equipment to be safely unblocked;
(r) the description of the adjustment and maintenance operations that should be carried out by the user and the preventive maintenance measures that should be observed;
(s) instructions designed to enable adjustment and maintenance to be carried out safely, including the protective measures that should be taken during these operations;
(t) the specifications of the spare parts to be used, when these affect the health and safety of operators;
(u) the following information on airborne noise emissions:
— the A-weighted emission sound pressure level at workstations, where this exceeds 70 dB(A); where this level does not exceed 70 dB(A), this fact must be indicated,
— the peak C-weighted instantaneous sound pressure value at workstations, where this exceeds 63 Pa (130 dB in relation to 20 μPa),
— the A-weighted sound power level emitted by the machinery, where the A-weighted emission sound pressure level at workstations exceeds 80 dB(A).
These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced.
In the case of very large machinery, instead of the A-weighted sound power level, the A-weighted emission sound pressure levels at specified positions around the machinery may be indicated.
Where the harmonised standards are not applied, sound levels must be measured using the most appropriate method for the machinery. Whenever sound emission values are indicated the uncertainties surrounding these values must be specified. The operating conditions of the machinery during measurement and the measuring methods used must be described.
Where the workstation(s) are undefined or cannot be defined, A-weighted sound pressure levels must be measured at a distance of 1 metre from the surface of the machinery and at a height of 1,6 metres from the floor or access platform. The position and value of the maximum sound pressure must be indicated.
Where specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels, those Directives must be applied and the corresponding provisions of this section shall not apply;
(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons, in particular persons with active or non-active implantable medical devices, information concerning the radiation emitted for the operator and exposed persons.
Reproduction from Machinery Regulation Annex III - 1.7.4.2
1.7.4.2. Contents of the instructions for use
1. Instructions for use shall contain, where applicable, at least the following information:
(a) the business name and full address of the manufacturer and, where applicable, of its authorised representative;
(b) the designation of the machinery or related product as marked on the machinery or related product itself, except for the serial number (see section 1.7.3);
(c) the EU declaration of conformity, or the internet address or machine readable code, where the EU declaration of conformity can be accessed, in accordance with Article 10(8);
(d) a general description of the machinery or related product;
(e) the drawings, diagrams, descriptions and explanations necessary for the use, maintenance and repair of the machinery or related product and for checking its correct functioning;
(f) a description of the workstation(s) likely to be occupied by operators;
(g) a description of the intended use of the machinery or related product;
(h) warnings concerning the ways in which the machinery or related product must not be used that experience has shown might occur;
(i) assembly, installation and connection instructions, including drawings, diagrams and the means of attachment and the designation of the chassis or installation on which the machinery or related product is to be mounted;
(j) instructions relating to installation and assembly for reducing noise or vibration;
(k) instructions for the putting into service and use of the machinery or related product and, if necessary, instructions for the training of operators;
(l) information about the residual risks that remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted;
(m) instructions on the protective measures to be taken by the user, including, where appropriate, the personal protective equipment to be provided;
(n) the essential characteristics of tools, which may be fitted to the machinery or related product;
(o) the conditions in which the machinery or related product meets the requirement of stability during use, transportation, assembly, dismantling when out of service, testing or foreseeable breakdowns;
(p) instructions with a view to ensuring that transport, handling and storage operations can be made safely, giving the mass of the machinery or related product and of its various parts where these are regularly to be transported separately;
(q) the operating method to be followed in the event of accident or breakdown; if a blockage is likely to occur, the operating method to be followed so as to enable the equipment to be safely unblocked;
(r) the description of the adjustment and maintenance operations that should be carried out by the user and the preventive maintenance measures that should be observed taking account of the design and the use of the machinery or related product;
(s) instructions designed to enable adjustment and maintenance to be carried out safely, including the protective measures that should be taken during these operations;
(t) the specifications of the spare parts to be used, when these affect the health and safety of operators;
(u) the following information on airborne noise emissions:
(i) the A-weighted emission sound pressure level at workstations, where this exceeds 70 dB (A); where this level does not exceed 70 dB (A), this fact shall be indicated;
(ii) the peak C-weighted instantaneous sound pressure value at workstations, where this exceeds 63 Pa (130 dB in relation to 20 μPa);
(iii) the A-weighted sound power level emitted by the machinery or related product, where the A-weighted emission sound pressure level at workstations exceeds 80 dB (A).
These values shall be either those actually measured for the machinery or related product in question or those established on the basis of measurements taken for technically comparable machinery or for a technically comparable related product, which is representative of the machinery or related product to be produced.
In the case of very large machinery or a related product, instead of the A-weighted sound power level, the A-weighted emission sound pressure levels at specified positions around the machinery or related product may be indicated.
Where the harmonised standards or common specifications adopted by the Commission in accordance with Article 20(3) cannot be applied, sound levels shall be measured using the most appropriate method for the machinery or related product.
Whenever sound emission values are indicated, the uncertainties surrounding these values shall be specified. The operating conditions of the machinery or related product during measurement and the measuring methods used shall be described.
Where the workstation(s) are undefined or cannot be defined, A-weighted sound pressure levels shall be measured at a distance of 1 m from the surface of the machinery or related product and at a height of 1,6 m from the floor or access platform. The position and value of the maximum sound pressure shall be indicated.
With respect to noise reduction machinery or related products, the instructions for use shall specify, where appropriate, how to correctly assemble and install that equipment (see also section 1.7.4.2(1), point (j)).
Where specific Union legal acts lay down other requirements for the measurement of sound pressure levels or sound power levels, those legal acts shall be applied and the corresponding provisions of this section shall not apply;
(v) information on the necessary precautions, devices and means for the immediate and gentle rescue of persons;
(w) where machinery or related products are likely to emit non-ionising radiation, which may cause harm to persons, in particular persons with active or non-active implantable medical devices, information concerning the radiation emitted for the operator and exposed persons;
(x) where the design of machinery or related products allows emissions of hazardous substances from the machinery or related product, the characteristics of the capturing, filtration or discharge device if such device is not provided with the machinery or related product, and any of the following:
(i) the flow rate for the emission of hazardous materials and substances from the machinery or related product;
(ii) the concentration of hazardous materials or substances around the machinery or related product coming from the machinery or related product or from materials or substances used with the machinery or related product;
(iii) the effectiveness of the capturing or filtration device and the conditions to be observed to maintain its effectiveness over time.
The values referred to in the first subparagraph shall either be actually measured for the machinery or related product in question or established based on measurements in respect of technically comparable machinery or a technically comparable related product, which is representative of the state of the art.
In which language must the instructions be provided in?
According to the Machinery Directive, the machine must be accompanied by instructions in the official language(s) of the Member State where it is placed on the market or put into service. If the instructions are translated, the original version must also be included. The Machinery Regulation stipulates that the language must be easily understood by users and determined by the Member State concerned. Therefore, check the language requirement for each country where the machine is to be made available.
What must instructions contain?
Annex I of the Machinery Directive and Annex III of the Machinery Regulation specify in section 1.7.4.2 of each document the minimum information that the instructions must contain, where applicable. This includes, among other things, the intended use, residual risks, and instructions for safe use and maintenance.
Do all points in 1.7.4.2 have to be included for every machine?
No. Both regulatory frameworks state that the information must be provided where applicable. It must be assessed for the specific machinery which points are relevant.
Can the instructions be in digital format?
The Machinery Regulation permits digital instructions subject to certain conditions. The manufacturer must, among other things, indicate how they can be accessed and provide them in a format that allows the user to print, download, and save them. The Regulation also contains specific rules regarding access to paper format and safety information for non-professional users.
