Key takeaways:
The text explains the role of standards harmonized with the Machinery Directive 2006/42/EC and the classification into Type A, B, and C standards, together with examples.
- The Machinery Directive 2006/42/EC regulates machinery safety in the EU and supports CE marking.
- Harmonized standards are developed by CEN and CENELEC under a mandate from the European Commission.
- Applying the standards gives rise to a presumption of conformity with the Directive’s essential health and safety requirements.
- Type A standards (e.g. EN ISO 12100:2012) describe general principles for design and risk assessment.
- Type B (B1/B2) and C standards specify the requirements in greater detail; examples include EN 349, EN ISO 13849, and EN ISO 20430.
The Machinery Directive 2006/42/EC is the key legal act governing machinery safety in the European Union. To support the implementation of this directive, harmonised standards have been developed to help manufacturers meet its requirements. These standards ensure that machinery complies with safety requirements, allowing CE-marked equipment to be placed on the market.
Harmonised standards in the context of the Machinery Directive 2006/42/EC
What are harmonised standards?
Harmonised standards are a set of technical standards developed by the European standardisation organisations, such as CEN (European Committee for Standardization) and CENELEC (European Committee for Electrotechnical Standardization). These standards are prepared at the request of the European Commission to support European Union legislation, including the Machinery Directive 2006/42/EC.
The role of harmonised standards
Harmonised standards play a key role in ensuring that machinery complies with the Machinery Directive 2006/42/EC. When these standards are applied, machinery manufacturers may presume that their products meet the essential health and safety requirements set out in the directive. This, in turn, simplifies the process of CE certification of machinery, which is important for placing products on the EU market.
Types of harmonised standards and their application
Type A standards
Type A standards, such as EN ISO 12100:2012, provide the foundation for machinery design and risk assessment. They define general principles that apply to all categories of machinery. They help establish a framework for safe machinery design, but on their own they are not sufficient to provide full presumption of conformity with the Machinery Directive 2006/42/EC. Applying Type A standards is the first step in the conformity process, but it must be supplemented by Type B or Type C standards, which contain more detailed requirements.
Type B standards
Type B standards focus on specific safety aspects or types of safeguards. One example is EN 349:1993+A1:2008, which specifies minimum gaps to prevent crushing of parts of the human body. The use of Type B standards is essential, as it provides a basis for presumption of conformity with the directive’s essential requirements, provided that the technical solutions specified in these standards are appropriate for the specific category of machinery. Type B standards can be divided into two groups:
- B1 standards – covering specific safety aspects (e.g. minimum gaps, noise, vibration).
- B2 standards – covering safeguards (e.g. control devices, guards).
| Standard type | Standard number | Standard title | Description |
|---|---|---|---|
| B1 | EN ISO 13854 | Safety of machinery – Minimum gaps to avoid crushing of parts of the human body | Specifies minimum gaps that prevent parts of the human body from being crushed by moving elements. |
| B1 | EN 547 | Safety of machinery – Human body measurements – Part 1: Principles for determining the dimensions required for openings for whole-body access into machinery | Specifies the dimensions of access openings for the entire human body. |
| B1 | EN 547 | Safety of machinery – Human body measurements – Part 2: Principles for determining the dimensions required for access openings | Specifies the dimensions of access openings for different parts of the body. |
| B1 | EN 614 | Safety of machinery – Ergonomic design principles – Part 1: Terminology and general principles | Specifies the basic ergonomic principles for machinery design. |
| B1 | EN 842 | Safety of machinery – Visual danger signals – General requirements, design and testing | Specifies requirements for visual warning signals on machinery. |
| B1 | EN 894 | Safety of machinery – Ergonomics requirements for the design of displays and control actuators – Part 1: General principles for human interactions with displays and control actuators | Specifies principles for human-machine interaction. |
| B2 | EN ISO 13851 | Safety of machinery – Two-hand control devices – Functional aspects – Principles for design | Specifies requirements for two-hand control devices. |
| B2 | EN ISO 14120 | Safety of machinery – Guards – General requirements for the design and construction of fixed and movable guards | Specifies requirements for the design and construction of guards on machinery. |
| B2 | EN ISO 14119 | Safety of machinery – Interlocking devices associated with guards – Principles for design and selection | Specifies principles for the design and selection of interlocking devices associated with guards. |
| B2 | EN 60204 | Safety of machinery – Electrical equipment of machines – Part 1: General requirements | Specifies requirements for the electrical equipment of machines. |
| B2 | EN ISO 13849 | Safety of machinery – Safety-related parts of control systems – Part 1: General principles for design | Specifies principles for the design of safety-related control systems for machinery. |
| B2 | EN ISO 13850 | Safety of machinery – Emergency stop function – Principles for design | Specifies principles for the design of emergency stop systems on machinery. |
| B2 | EN ISO 14119 | Safety of machinery – Interlocking devices associated with guards – Principles for design and selection | Specifies principles for the design and selection of interlocking devices associated with guards. |
| B2 | EN ISO 14120 | Safety of machinery – Guards – General requirements for the design and construction of fixed and movable guards | Specifies requirements for the design and construction of guards on machinery. |
Type C standards
Type C standards contain specifications for specific categories of machinery. Each machinery category has its own dedicated standard that addresses all safety aspects related to its use. One example is EN ISO 20430 for plastics injection moulding machines. Type C standards may refer to Type A and B standards, indicating which specifications apply to a given machinery category. If there is a conflict between a Type C standard and Type A or B standards, the Type C standard takes precedence.
Harmonised standards: implementation process
Development and publication of standards
The process of developing harmonised standards begins with a mandate from the European Commission to the European standardisation organisations. Once developed, the standards are published in the Official Journal of the European Union, which means they are formally recognised under EU legislation.
Use of standards by manufacturers
Machinery manufacturers may apply harmonised standards on a voluntary basis. Applying these standards helps ensure that their products comply with the essential requirements of the directive. If they do not apply them, the manufacturer must provide other evidence that those requirements have been met.
Harmonised standards: benefits of their use
Simplifying CE certification
Applying harmonised standards significantly simplifies the CE certification process for machinery. By applying the relevant standards, a manufacturer may presume that the product meets all essential requirements of the Directive, which makes it easier to prepare the technical documentation and declaration of conformity.
Improved safety and quality
Harmonised standards ensure a high level of machinery safety, helping to protect users’ health. In addition, applying these standards improves machinery quality and reliability, which is crucial for competitiveness on the market.
Easier market placement
Machinery that complies with harmonised standards can be placed on the EU market more easily. CE marking confirms compliance with health and safety requirements, which is important for product acceptance by customers and market surveillance authorities.
Harmonised standards under the Machinery Directive 2006/42/EC are a key part of the machinery safety system in the European Union. Their use by manufacturers not only simplifies the CE certification process for machinery, but also improves product safety, quality, and competitiveness on the EU market.
Harmonised standards: further information and consultation
Machinery manufacturers can use the services of design offices and companies offering engineering outsourcing to ensure that their products comply with harmonised standards. Where there is any doubt, it is also worth carrying out a safety audit and consulting experts in project management and machinery design.
Harmonised standards are an integral part of today’s machinery market, ensuring the safe and legally compliant operation of machinery. They make it possible to develop innovative and safe products that meet the highest quality and safety standards.
Examples of harmonised standards
EN ISO 13849 – Safety of machinery: safety-related parts of control systems
The EN ISO 13849 standard sets out requirements for the design and integration of machine control systems that affect safety. It covers risk assessment and ensures that control systems are designed and built in a way that minimises the risk of failures that could lead to accidents. This standard is widely used in the machinery industry, especially in industrial automation, where control systems play a key role in ensuring the safe operation of machinery.
EN 60204-1:2018-12- – Safety of machinery: electrical equipment of machines
The EN 60204 standard concerns the electrical safety of machinery. It sets out requirements for machine electrical systems, including their design, assembly, and maintenance. This standard is essential to ensure that machinery is safe to use and does not pose a hazard to operators or other people nearby. Applying this standard is mandatory for machinery manufacturers who want to obtain CE certification.
EN 60204- Safety of machinery: functional safety of electrical, electronic and programmable electronic control systems
The EN 60204 standard sets out requirements for the design, integration, and validation of machine control systems that use electrical, electronic, and programmable electronic components. The purpose of this standard is to ensure an appropriate level of functional safety, which is particularly important in advanced industrial automation systems.
Challenges and the future of harmonised standards
Rapid technological change
Rapid technological development requires harmonised standards to be updated continuously so that they keep pace with new technical solutions and maintain an appropriate level of safety.
Integration of new technologies
The integration of new technologies, such as Industry 4.0, industrial automation, and robotics, requires new standards to be developed or existing ones to be updated so that they cover new safety aspects.
Overview of selected harmonised standards
EN ISO 12100 – General principles for design, risk assessment and risk reduction
The EN ISO 12100 standard is the foundation of machinery safety. It sets out general design principles, risk assessment, and methods for risk reduction. This is a Type A standard, which means it covers basic concepts and design principles applicable to all machinery. The key elements of the standard include:
- Risk assessment: Identifying hazards, evaluating the risks associated with them, and determining appropriate risk reduction measures.
- Design principles: Introducing design principles intended to minimise risk at the concept and design stages.
- Documentation: Defining requirements for technical documentation and machinery operating instructions.
EN ISO 14120 – Guards – General requirements for the design and construction of fixed and movable guards
The EN ISO 14120 standard specifies requirements for the design and construction of machine guards intended to prevent access to hazardous areas. The key elements of the standard include:
- Types of guards: Defining the differences between fixed and movable guards and their applications.
- Design requirements: Principles for designing guards that must be robust, easy to install and remove, and provide adequate protection.
- Testing and certification: Requirements for testing guards to confirm their effectiveness and durability.
EN ISO 13854:2020-01 – Minimum gaps to avoid crushing of parts of the human body
The EN ISO 13854 standard defines minimum gaps that prevent parts of the human body from being crushed by moving machine elements. This is a Type B1 standard covering specific safety aspects. The key elements of the standard include:
- Minimum gaps: Specifying the minimum distances between moving machine parts and parts of the body that must be maintained to prevent crushing.
- Practical applications: Examples of how minimum gaps are applied in different types of machinery and equipment.
EN ISO 13849 – Safety-related parts of control systems
The EN ISO 13849 standard covers the design and assessment of safety-related machine control systems, also referred to in terms of Performance Levels. The key elements of the standard include:
- Risk assessment: Identifying hazards and assessing the risks they pose to control systems.
- Performance Levels (Performance Levels, PL): Defining five Performance Levels (PL a to PL e) that describe the ability of a control system to perform a safety function under specified conditions.
- System architecture: Requirements for the structure of control systems, including redundancy, diagnostics, and fault tolerance.
- Validation: The process of validating control systems to ensure they meet safety and performance level requirements.
Application in industrial practice
Risk assessment and minimum gaps
Applying EN ISO 12100 and EN ISO 13854 is essential at the machine design stage. Machinery manufacturers should carry out a detailed risk assessment according to ISO 12100, identifying all potential hazards and defining the minimum gaps that must be maintained to prevent accidents.
Machine guards
Designing guards in accordance with EN ISO 14120 is essential to ensure that machinery is safe to use. Guards must be designed so that they are difficult to remove without tools, and opening them causes the machine to stop.
Control systems
Applying EN ISO 13849-1 makes it possible to design advanced control systems capable of monitoring and controlling machine safety functions. This makes it possible to achieve a high level of safety and minimise the risk of control system failures.
Harmonised standards under the Machinery Directive 2006/42/EC (see also the Regulation on Machinery 2023/1230/EU) are a key part of the machinery safety framework in the European Union. Applying these standards helps manufacturers streamline CE certification of machinery, improve product safety and quality, and bring products to market more easily. In the future, continuous updates and the integration of new technologies will be essential to maintaining high safety standards and compliance with EU regulations.
The list of harmonised standards is available on the official EU website: https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards/machinery-md_en
Standards Harmonized with the Machinery Directive 2006/42/EC
These are technical standards developed by European standardization organizations such as CEN and CENELEC, at the request of the European Commission. They support compliance with the requirements of the Machinery Directive 2006/42/EC.
Applying harmonized standards allows the manufacturer to presume conformity with the Directive’s essential health and safety requirements. This facilitates placing the machine on the EU market with CE marking.
Type A (e.g. EN ISO 12100:2012) sets out general principles for design and risk assessment for all machinery. Type B covers specific safety aspects or safeguards, while Type C contains requirements for specific categories of machinery.
B1 covers specific safety aspects, such as the minimum gaps to prevent crushing (EN ISO 13854). B2 covers safeguards, such as guards (EN ISO 14120) or emergency stop functions (EN ISO 13850).
In the event of a conflict, the Type C standard takes precedence. This is because it contains specifications for the given category of machinery and takes its specific risks into account.