Comprehensive Guide to Technical Documentation of Machines Under the New 2023/1230 Regulation

Understanding the Technical Documentation of Machines in Light of New Regulations

The technical documentation of machines plays a crucial role in ensuring regulatory compliance and user safety. The new Machinery Regulation (EU) 2023/1230, which replaces the Machinery Directive 2006/42/EC, refines and expands existing requirements. It includes risk analyses that were previously mandated, now broadened to incorporate new technologies and more precisely defined requirements, including autonomous technologies and additional transparency requirements. These changes stem from the need to adapt regulations to increasingly advanced technologies. When the Machinery Directive 2006/42/EC was introduced over 15 years ago, technologies like self-learning systems or autonomous machines were nascent and did not require specific regulations. Today, their development necessitates precise regulations addressing new risks and technical challenges. Technical documentation not only forms the basis for compliance verification but also supports design and production processes, minimizing errors and hazards.

The regulation mandates that technical documentation includes several detailed elements. This article outlines how each of these elements should be structured according to the regulations. We have divided the technical documentation into parts, focusing on content and application.

Technical Documentation of Machines in the Machinery Regulation

Annex IV of the Machinery Regulation 2023/1230 provides a comprehensive list of requirements for how it should appear. Let’s delve into a more precise explanation.

The technical documentation must specify the measures employed by the manufacturer to ensure the machine or related product complies with the essential health and safety requirements outlined in Annex III.

This means the manufacturer must detail the measures used, such as mechanical guards, interlocking systems, safety controls, or functional test procedures. The documentation should include risk analyses identifying hazards and descriptions of how to eliminate or minimize them. Required are also technical diagrams, test results, and references to applied standards, collectively ensuring compliance with the regulation.

a) A full description of the machine or related product and its intended use;

The full description should include detailed information about the machine’s purpose, usage conditions, and any operational limitations. Examples include descriptions of processes the machine will be used in and work environments (e.g., industrial, outdoor). The manufacturer must clearly indicate the machine’s functions and the safety it offers in standard and non-standard applications.

b) Risk assessment documentation presenting the procedure conducted, including:

The manufacturer must present a risk analysis in line with the requirements of Regulation 2023/1230. This analysis includes:

(i) A list of essential health and safety requirements applicable to the machine or related product;

The manufacturer must specify all applicable requirements arising from the Regulation, such as protection against mechanical, electrical, or chemical risks.

(ii) Description of protective measures implemented to meet each applicable requirement and indication of residual risk;

Examples might include mechanical guards, safety interlocks, or detection sensors. The manufacturer should also indicate what risk remains despite the implemented measures and what actions are planned to minimize this risk, such as operator training.

Risk analysis involves identifying potential hazards, such as uncontrolled machine part movement, electric shock risk, or harmful substance emissions. Methods for eliminating these hazards must be specified, such as using mechanical guards or automatic detection systems. The regulation does not require specific standards, but a good example is EN ISO 12100, which describes a proven risk assessment and reduction process. Regulation in Annex IV point f) clearly states that if harmonized standards like EN ISO 12100 are not applied, the manufacturer must demonstrate what other technical specifications or methods were used to meet the requirements. The analysis must also consider residual risks and ways to reduce them, such as additional maintenance procedures or implementing specialized operator instructions.

c) Design and manufacturing drawings and diagrams of the machine or related product and their components, subassemblies, and circuits;

Technical drawings must be detailed, covering both the machine’s construction and its key elements, such as mechanical, electrical, or hydraulic systems. For example, safety circuit diagrams, guard construction, or control element placement. All this information aids in compliance assessment and conducting any repairs or modifications.

d) Descriptions and explanations necessary to understand the drawings and diagrams referred to in point c) and the functioning of the machine or related product;

The documentation should contain clear explanations and descriptions of technical drawings to enable understanding of the machine’s individual elements. For instance, if a diagram shows a control system, the description should explain what processes it controls and what its limitations are. This is particularly important for complex machines, where graphics alone may be insufficient.

e) References to harmonized standards referred to in Article 20(1) or common specifications adopted by the Commission in accordance with Article 20(3) that have been applied for the design and manufacture of the machine or related product. In the case of partial application of harmonized standards or common specifications, the documentation must specify which parts of the standards have been applied;

The manufacturer should clearly indicate which harmonized standards were applied in the machine’s design and production process. If these standards were only partially applied, it should be specified which parts were used and for what purpose. For example, EN ISO 13849-1 may be applied in designing the safety control system but not necessarily in other aspects of the machine.

f) If harmonized standards or common specifications have not been applied or have been applied only partially, descriptions of other technical specifications used to meet all applicable essential health and safety requirements;

If harmonized standards are not applied, the manufacturer must detail alternative technical methods that ensure compliance with essential requirements. An example might be using internal procedures based on a detailed risk analysis. Such a description should be sufficiently detailed to enable compliance assessment by the relevant supervisory authorities.

g) Reports or results of design calculations, tests, inspections, and examinations carried out to verify the machine or related product’s compliance with applicable essential health and safety requirements;

The manufacturer must present test results and calculations confirming compliance with essential requirements. For example, strength analyses of the machine’s structure, verification of the emergency stop system’s effectiveness, or noise emission measurements.

h) Description of measures used by the manufacturer during production of the machine or related product to ensure compliance of the manufactured machine or product with the design specifications;

The documentation should include information on quality control procedures used in the production process. This may include regular sampling tests, checking assembly accuracy, or verifying the functionality of key components.

i) A copy of the operating instructions and information specified in Annex III section 1.7.4;

Every machine must have an operating manual tailored to the language of the country where it is marketed. This manual should cover all aspects of safe machine use, including installation, maintenance, and potential risks during operation.

j) Where applicable, the EU declaration of incorporation of incomplete machinery as specified in Annex V, Part B, and the assembly instructions specified in Annex XI;

If the machine is incomplete, the manufacturer must provide the appropriate declaration and detailed assembly instructions. These documents should enable safe completion and use of the machine in compliance with regulations.

k) Where applicable, copies of the EU declaration of conformity of machines or related products, as well as any products covered by other Union harmonization legislation incorporated into the machine or related product;

The manufacturer must attach declarations of conformity for all machine components subject to other EU regulations, such as electrical devices compliant with the low voltage directive.

l) In the case of machines or related products produced in series, internal measures to be taken to ensure compliance of the machine or related product with the provisions of this regulation;

The manufacturer should specify internal quality control procedures that ensure each machine in serial production meets the same standards as the tested and certified model.

m) Source code or programming logic contained in safety-related software demonstrating compliance of the machine or related product with this regulation, made available upon justified request of the competent national authorities, when necessary for these authorities to verify compliance with the essential health and safety requirements specified in Annex III;

If the machine’s software contains safety functions, the manufacturer must ensure that the source code or programming logic is adequately documented and can be made available upon request by supervisory authorities. The documentation should clearly explain which software functions are responsible for specific safety aspects, such as emergency stop or hazardous area monitoring. The goal is to enable verification that the software operates as intended and that appropriate measures have been taken to minimize risks arising from its operation.

n) In the case of sensor-controlled, remotely operated, or autonomous machines or related products, where safety-related actions are controlled by sensor data, a description of, where applicable, the general characteristics, capabilities, and limitations of the system, data, development, testing, and approval processes applied;

The documentation should include details about autonomous systems and sensors, including a description of their functions, detection capabilities, and limitations. For example, what data sensors collect and how it is processed for decision-making.

o) Results of tests and trials conducted by the manufacturer on components, equipment, or machines or related products to determine whether their design or manufacturing allows for safe assembly and commissioning of the machine.

The manufacturer should present test reports of machine components, such as guards, control systems, or drive mechanisms, to demonstrate that their design complies with safety requirements.

Checklist for Complete Documentation – Do I Have Everything?

How Do the New Requirements Differ from the Machinery Directive?

At first glance, it may seem that little has changed, but we would like to highlight some truly significant differences!

1. Digital Safety

• Directive 2006/42/EC: No specific requirements for digital elements.
• Regulation 2023/1230:
  • Mandates documentation of digital safety elements, including testing procedures, corrective actions, and threat monitoring methods (Annex III, point 4.2).

2. Incomplete Machines

• Directive 2006/42/EC:
  • Required only a general description of design principles and a list of harmonized standards (Annex VII, Part B, Paragraph 1).
• Regulation 2023/1230:
  • Requires detailed information enabling conformity assessment of the machine in the context of its integration into a machine ensemble (Annex III, Paragraph 5.1).
  • Includes digital security and its implementation methods.

3. Harmonized Standards and Alternative Technical Specifications

• Directive 2006/42/EC: Indicated the necessity of using harmonized standards but did not require detailed justification for their absence.
• Regulation 2023/1230:
  • Introduces point f) of Annex IV, which requires manufacturers not using harmonized standards to provide a detailed justification for choosing alternative technical specifications. They must demonstrate that these meet all essential health and safety requirements.
  • This significantly raises documentation requirements for manufacturers opting out of harmonized standards, imposing an obligation to present a full technical analysis and test results confirming the effectiveness of the applied solutions.

FAQ: Technical Documentation of Machines