The Machinery Directive 2006/42/EC is a pivotal document governing machine safety within the European Union. To facilitate compliance with this directive, harmonized standards have been developed, aiding manufacturers in meeting the directive’s requirements. These standards ensure that machines meet safety requirements, enabling the introduction of CE-marked devices to the market.
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Harmonized Standards with the Machinery Directive 2006/42/EC
What are Harmonized Standards?
Harmonized standards are a set of technical standards developed by European Standardization Organizations like CEN (European Committee for Standardization) and CENELEC (European Committee for Electrotechnical Standardization). These standards are created at the request of the European Commission to support EU legislation, including the Machinery Directive 2006/42/EC.
The Role of Harmonized Standards
Harmonized standards play a crucial role in ensuring that machines comply with the Machinery Directive 2006/42/EC. By applying these standards, machine manufacturers can presume that their products meet the essential health and safety requirements set out in the directive. This, in turn, simplifies the CE certification process, which is vital for introducing products to the EU market.
Types of Harmonized Standards and Their Application
Type A Standards
Type A standards, such as EN ISO 12100:2010, provide a foundation for machine design and risk assessment. They outline general principles applicable to all categories of machines, helping to create a framework for safe machine design. However, they are not sufficient on their own to ensure full compliance with the Machinery Directive 2006/42/EC. Type A standards are the first step in ensuring compliance but must be supplemented with Type B or C standards, which contain more detailed requirements.
Type B Standards
Type B standards focus on specific safety aspects or types of safeguards. An example is EN 349:1993+A1:2008, which specifies minimum gaps to prevent crushing of body parts. Applying Type B standards is crucial as they provide a basis for presuming compliance with the directive’s essential requirements, provided the technical solutions specified in these standards are adequate for the specific category of machines. Type B standards can be divided into two groups:
- B1 Standards – Addressing specific safety aspects (e.g., minimum gaps, noise, vibrations).
- B2 Standards – Addressing safeguards (e.g., control devices, guards).
| Type of Standard | Standard Number | Title | Description |
|---|---|---|---|
| B1 | EN ISO 13854 | Safety of machinery – Minimum gaps to avoid crushing of parts of the human body | Specifies minimum gaps to prevent crushing of the human body by moving parts. |
| B1 | EN 547 | Safety of machinery – Human body dimensions – Part 1: Principles for determining the dimensions of openings for whole body access into machinery | Specifies dimensions of access openings for the whole human body. |
| B1 | EN 547 | Safety of machinery – Human body dimensions – Part 2: Principles for determining the dimensions of access openings | Specifies dimensions of access openings for various body parts. |
| B1 | EN 614 | Safety of machinery – Ergonomic design principles – Part 1: Terminology and general principles | Specifies basic ergonomic design principles for machinery. |
| B1 | EN 842 | Safety of machinery – Visual danger signals – General requirements, design, and testing | Specifies requirements for visual danger signals on machinery. |
| B1 | EN 894 | Safety of machinery – Ergonomic 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 designing and constructing machine guards. |
| B2 | EN ISO 14119 | Safety of machinery – Interlocking devices associated with guards – Principles for design and selection | Specifies principles for designing and selecting 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 designing safety-related parts of control systems. |
| B2 | EN ISO 13850 | Safety of machinery – Emergency stop function – Principles for design | Specifies principles for designing emergency stop systems on machines. |
| B2 | EN ISO 14119 | Safety of machinery – Interlocking devices associated with guards – Principles for design and selection | Specifies principles for designing and selecting 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 designing and constructing machine guards. |
Type C Standards
Type C standards contain specifications for specific categories of machines. Each machine category has its specific standard that considers all safety aspects related to its use. An example is EN ISO 20430 for plastic injection molding machines. Type C standards may refer to Type A and B standards, indicating which specifications apply to a particular machine category. In case of conflict between a Type C standard and Type A or B standards, Type C standards take precedence.
Harmonized Standards: Implementation Process
Development and Publication of Standards
The development of harmonized standards begins with a mandate from the European Commission, directed to European Standardization Organizations. Once developed, the standards are published in the Official Journal of the European Union, marking their official recognition within EU legislation.
Application of Standards by Manufacturers
Machine manufacturers can voluntarily apply harmonized standards. Using these standards ensures that their products comply with the directive’s essential requirements. In the absence of compliance, the manufacturer must provide other evidence of meeting these requirements.
Harmonized Standards: Benefits of Application
Facilitating CE Certification
Applying harmonized standards significantly simplifies the CE certification process for machines. By using appropriate standards, manufacturers can presume that their product meets all the directive’s essential requirements, simplifying the preparation of technical documentation and the declaration of conformity.
Enhancing Safety and Quality
Harmonized standards ensure a high level of machine safety, contributing to the protection of users’ health. Additionally, applying these standards impacts the quality and reliability of machines, which is crucial for market competitiveness.
Easing Market Entry
Machines compliant with harmonized standards can be more easily introduced to the EU market. CE marking confirms compliance with safety and health requirements, which is essential for product acceptance by customers and market surveillance authorities.
Harmonized standards with the Machinery Directive 2006/42/EC are a key component of the machine safety assurance system in the European Union. Applying these standards by manufacturers not only simplifies the CE certification process for machines but also contributes to improved safety, quality, and competitiveness of products in the EU market.
Harmonized Standards: Further Information and Consultations
Machine manufacturers can benefit from the services of design offices and companies offering engineering outsourcing to ensure their products comply with harmonized standards. In case of doubts, it is also advisable to conduct a safety audit and consult with experts in project management and machine design.
Harmonized standards are an integral part of today’s machinery market, ensuring safe and legally compliant machine operation. They enable the creation of innovative and safe products that meet the highest quality and safety standards.
Examples of Harmonized Standards
EN ISO 13849 – Safety of Machinery: Safety-Related Parts of Control Systems
EN ISO 13849 specifies requirements for the design and integration of machine control systems that impact safety. It addresses risk assessment and ensures that control systems are designed and built to minimize the risk of failures that could lead to accidents. This standard is widely used in the machinery industry, particularly in industrial automation, where control systems play a crucial role in ensuring safe machine operation.
EN 60204-1:2018-12 – Safety of Machinery: Electrical Equipment of Machines
EN 60204 addresses the electrical safety of machines. It specifies requirements for the electrical systems of machines, including their design, installation, and maintenance. This standard is crucial for ensuring that machines are safe to use and do not pose a risk to operators and others nearby. Compliance with this standard is mandatory for manufacturers seeking CE certification.
EN 60204 – Safety of Machinery: Functional Safety of Electrical, Electronic, and Programmable Electronic Control Systems
EN 60204 specifies requirements for the design, integration, and validation of machine control systems that use electrical, electronic, and programmable electronic elements. The aim of this standard is to ensure an appropriate level of functional safety, which is particularly important in advanced industrial automation systems.
Challenges and Future of Harmonized Standards
Dynamic Technological Changes
The rapid development of technology requires continuous updates to harmonized standards to keep pace with new technical solutions and ensure an appropriate level of safety.
Integration of New Technologies
The integration of new technologies, such as Industry 4.0, industrial automation, and robotics, requires the development of new standards or updates to existing ones to cover new safety aspects.
Discussion of Selected Harmonized Standards
EN ISO 12100 – General Principles for Design, Risk Assessment, and Risk Reduction
EN ISO 12100 is a fundamental standard in the field of machine safety. It specifies general design principles and risk assessment and risk reduction methods. As a Type A standard, it covers basic concepts and design principles applicable to all machines. Key elements of the standard include:
- Risk Assessment: Identifying hazards, assessing the risks associated with them, and determining appropriate risk reduction measures.
- Design Principles: Introducing design principles aimed at minimizing risk at the conceptual and construction stages.
- Documentation: Specifying requirements for technical documentation and user instructions for machines.
EN ISO 14120 – Guards – General Requirements for the Design and Construction of Fixed and Movable Guards
EN ISO 14120 specifies requirements for the design and construction of machine guards aimed at preventing access to hazardous areas. Key elements of the standard include:
- Types of Guards: Differentiating 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
EN ISO 13854 defines minimum gaps to prevent crushing of parts of the human body by moving machine elements. As a Type B1 standard, it addresses specific safety aspects. Key elements of the standard include:
- Minimum Gaps: Specifying minimum distances between moving machine parts and body parts that must be maintained to prevent crushing.
- Practical Applications: Examples of applying minimum gaps in different types of machines and equipment.
EN ISO 13849 – Safety-Related Parts of Control Systems
EN ISO 13849 addresses the design and assessment of machine control systems related to safety, also known as Performance Levels. Key elements of the standard include:
- Risk Assessment: Identifying hazards and assessing the risks they pose to control systems.
- Performance Levels (PL): Defining five performance levels (PL a to PL e) that determine a control system’s ability to perform safety functions 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 crucial during the machine design phase. Machine manufacturers should conduct a detailed risk assessment, identifying all potential hazards and specifying 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 machines are safe to use. Guards must be designed to be difficult to remove without tools, and their opening should cause the machine to stop.
Control Systems
Applying EN ISO 13849-1 allows for the design of advanced control systems capable of monitoring and controlling machine safety functions. This enables achieving a high level of safety and minimizing the risk of control system failures.
Harmonized standards with the Machinery Directive 2006/42/EC are a crucial element of the machine safety assurance system in the European Union. Applying these standards by manufacturers simplifies the CE certification process for machines, improves safety and product quality, and facilitates market entry. In the future, continuous updates and integration of new technologies will be key to maintaining high safety standards and compliance with EU regulations.
Harmonized standards are a set of technical standards developed by European Standardization Organizations (CEN, CENELEC) at the request of the European Commission. They support manufacturers in meeting the requirements of the Machinery Directive 2006/42/EC, ensuring machine compliance with safety requirements and enabling CE marking.
Harmonized standards are divided into three main types:
Type A Standards: Define basic design principles applicable to all machine categories.
Type B Standards: Focus on specific safety aspects (B1) or safeguards (B2).
Type C Standards: Concern specific machine categories and their detailed safety requirements.
Applying harmonized standards simplifies the CE certification process, ensures a higher level of machine safety and quality, and facilitates product entry into the EU market. By applying these standards, manufacturers can presume their product meets all directive requirements.
CE certification means that a product meets the essential health and safety requirements set out in the relevant EU directives, including the Machinery Directive 2006/42/EC. CE marking is necessary for legally introducing a machine to the EU market.
Minimum gaps are distances that must be maintained between moving machine parts and the human body to prevent crushing. They are specified in harmonized standards and depend on the machine’s specifics and the type of hazard.
Machine guards must be robust, difficult to remove without tools, and their opening should cause the machine to stop. They should effectively prevent access to hazardous areas and be designed according to harmonized standards.
Performance Levels (PL) define the ability of a machine’s control system to perform safety functions under specified conditions. PLs are classified from PL a (lowest safety level) to PL e (highest safety level).
A machine safety audit allows for the identification of potential hazards, assessment of machine compliance with harmonized standards, and recommendation of corrective actions. Regular audits help maintain a high level of safety and minimize accident risks.
B1 standards address specific safety aspects of machines, such as minimum gaps or noise levels. B2 standards focus on machine safeguards, such as interlocking devices, guards, and emergency stop systems.
Technical documentation must include detailed information about the design, construction, and operation of the machine. It should cover risk assessment results, technical specifications, drawings, schematics, user instructions, and evidence of compliance with harmonized standards. Documentation is crucial for obtaining CE certification.