Key takeaways:
The article discusses the main requirements of EN-ISO 11161 for designers and integrators, focusing on the system approach, documentation, and validation of safety measures.
- EN-ISO 11161 describes the safety of integrated manufacturing systems as a whole, taking machine interactions into account.
- It requires a risk assessment at the level of the entire system and the implementation of protective measures covering the interfaces between the machines.
- It is essential to define the system boundaries and functionality and to prepare the functional documentation and procedures
- The standard indicates the need to define and mark task zones and to provide automatic, manual, and service modes.
- Before commissioning, the protective measures must be validated (tests, inspections, audits), which is important, among other things, for the CE marking.
ISO 11161 is a fundamental standard for ensuring safety in integrated manufacturing systems. Its purpose is to ensure that complex production systems made up of multiple interacting machines are designed and operated safely for both operators and the surrounding environment. The key aspects of this standard that are particularly important for machine designers and industrial automation integrators are outlined below.
A holistic approach to safety
ISO 11161 emphasizes that an integrated manufacturing system should be treated as a whole rather than as a collection of individual elements. Risk assessment and the implementation of protective measures must cover the entire system, including the interactions between individual machines. This approach ensures comprehensive protection and minimizes risks arising from unforeseen interactions between different system components. In integrated manufacturing systems, risk may result not only from the operation of individual machines, but also from the way they interact with one another. For that reason, risk assessment must be carried out at the level of the entire system, not just its individual components.
Safety of Integrated Manufacturing Systems: Defining system boundaries
Defining the boundaries and functionality of the manufacturing system is essential for proper risk assessment and ensuring safety. System boundaries include physical and operational limits, as well as interfaces between machines. This specification makes it possible to determine precisely which system elements must be included in the risk assessment process. Functional documentation should include detailed descriptions of all machines and equipment within the system, their interfaces, as well as operating and maintenance procedures. This approach ensures that all safety aspects are addressed at the system design stage.
Risk assessment must cover all machines and equipment that form part of the integrated manufacturing system, taking into account the interactions between them.
Identifying and marking task zones
Defining task zones in which operators can safely perform their duties is a key requirement of the standard. These zones must be clearly marked and equipped with appropriate protective measures, such as machine guards, presence detection systems, interlocks, and related safety functions in industrial automation. Defining task zones supports effective risk management by allowing operators to carry out their tasks safely without exposure to hazards associated with machine operation.
Different operating modes
The standard requires different operating modes, such as automatic, manual, and service mode, to enable various tasks to be performed safely within the manufacturing system. Each operating mode must be properly designed and equipped with protective measures to ensure operator safety. Operating modes are especially important in complex manufacturing systems, where switching between different modes is necessary depending on the task being performed.
Safety of Integrated Manufacturing Systems: Comprehensive documentation
Providing detailed technical documentation is essential so that system users can operate, maintain, and repair the integrated manufacturing system safely and effectively. The documentation should include information on all aspects of the system, including safety procedures, operating instructions, maintenance plans, and descriptions of interfaces between machines. Comprehensive documentation ensures that everyone involved in operating the system is aware of potential hazards and knows how to perform their tasks safely. It is a key element of risk management and of demonstrating compliance with safety requirements, including the EU Declaration of Conformity for machinery.
Safety of Integrated Manufacturing Systems: Validation of protective measures
Before the system is commissioned, all protective measures must be verified and confirmed as effective in reducing risk to an acceptable level. This validation should include functional testing, documentation reviews, and compliance audits against harmonized standards. Validation of protective measures is critical because it confirms that all safeguards perform as intended and effectively protect operators from hazards. This is necessary to obtain the CE marking and demonstrate compliance with legal requirements, including new CE nameplate requirements.
System-level safeguards
Protective measures must be implemented not only at the level of individual machines, but also across the entire production system to ensure comprehensive machine safety. Safeguards must cover the interfaces between machines and provide protection in the event of a system failure. System-level safeguards include elements such as emergency stop systems, operator presence detection, and machine condition monitoring systems. All of these elements must be integrated in a way that ensures they operate effectively throughout the entire system.
Technical documentation should include detailed descriptions of operating procedures, maintenance procedures, and interfaces between machines to ensure full compliance with the standard’s requirements.
Safety of Integrated Production Systems: Muting and Blanking
Muting is the temporary automatic suspension of safety systems, such as presence sensors or light barriers, to allow materials to pass through a protected zone without triggering alarms or stopping the machine. This is particularly useful in automated production lines, where regularly interrupting machine operation would be inefficient.
Key features of muting:
- Temporary nature: Muting is always time-limited and is intended to allow materials to pass through a protected zone under specific, controlled conditions.
- Automation: The muting process is automatically controlled by the control system, which monitors conditions such as movement speed and the presence of objects to ensure that muting is applied only when it is safe to do so.
- Safety: Muting is implemented in a way that minimizes risk to operators. For example, muting may be applied only when the operator is not present in the hazard zone, and presence detection systems must remain active to prevent an operator from accidentally entering the hazardous area.
Example of muting in use: Imagine a production line where a conveyor transports raw materials through various stages of production. To maintain continuity of operation, the system can temporarily suspend a light barrier while the conveyor carries material through the protected zone. Once the material has passed through, the light barrier automatically returns to active mode, protecting operators from entering the hazardous area.
Blanking is the disabling of part of a presence detection system (e.g. sensors or light curtains) in specific areas to allow the machine to operate normally without interruption. Blanking is particularly useful in situations where certain machine components or transported materials may pass through the detection zone but do not pose a risk to operators.
Key features of blanking:
- Selectivity: Blanking involves disabling only specific sensors or parts of them, which makes it possible to maintain protective functions in other areas.
- Control: The blanking process is tightly controlled and monitored by the control system, which ensures that the disabled areas do not create a hazard.
- Adaptability: Blanking can be adjusted to different production situations, allowing flexible safety management.
- Key features of blanking:
- Selectivity: Blanking involves disabling only specific sensors or parts of them, which makes it possible to maintain protective functions in other areas.
- Control: The blanking process is tightly controlled and monitored by the control system, which ensures that the disabled areas do not create a hazard.
- Adaptability: Blanking can be adapted to different production situations, allowing flexible safety management under changing operating conditions. In industrial automation safety functions, this adaptability is crucial because it enables protective systems to be dynamically adjusted to changing production scenarios.
| Function | Muting | Blanking |
|---|---|---|
| Definition | Temporary suspension of safety systems | Disabling part of the presence detection system in specific areas |
| Example of use | Passage of materials through a protected zone in an automated production line | Normal machine operation without interruption when certain elements can pass through the zone |
| Key features | Temporary nature, automation, minimizing risk to operators | Selectivity, control, adaptability to different production situations |
ISO 11161 highlights the key aspects of ensuring safety in integrated manufacturing systems. A holistic approach to risk assessment, defining system limits, establishing task zones, accounting for different operating modes, comprehensive documentation, validation of protective measures, system-level safeguards, and advanced mechanisms such as muting and blanking are all fundamental to effective safety management.
Machine designers and industrial automation integrators must take these guidelines into account to ensure the safe and efficient operation of complex manufacturing systems in line with the highest safety standards and legal requirements. Compliance with ISO 11161 not only improves safety, but also optimizes production processes by reducing the risk of downtime and failures, which in turn leads to higher production quality and greater customer satisfaction.
In the context of the Machinery Directive 2006/42/EC and the Machinery Regulation 2023/1230, implementing ISO 11161 is an important part of achieving regulatory compliance and obtaining CE certification for machinery. As a result, manufacturing systems can be used safely on the European market while meeting all applicable safety and health requirements. For a broader regulatory overview, see the Machinery Regulation 2023/1230/EU.
Industrial automation is a key element of modern production lines, enabling greater operational efficiency and safety. Machine assemblies integrated through advanced control systems such as SCADA and PLC programming allow production processes to be monitored and controlled with precision. As digital integration expands, cybersecurity in automation also becomes an important consideration in maintaining safe and reliable operation.
The integration of production process automation and advanced technologies such as industrial robots and SCADA and PLC systems requires careful project management and regular safety audits. Engineering outsourcing and cooperation with an experienced design office can significantly improve the efficiency and safety of production automation projects. This is especially relevant for a machine manufacturer operating under the new regulatory framework.
Ultimately, applying appropriate protective measures and systematically monitoring and controlling the condition of manufacturing systems in line with the guidelines of ISO 11161 helps create safe and reliable production lines that meet the highest quality and safety standards. Where existing equipment is involved, adapting machines to minimum requirements may also be an important step in improving overall system safety.
Safety of Integrated Production Systems
Standard EN-ISO 11161 covers the safety of integrated manufacturing systems consisting of multiple interacting machines. Its purpose is to ensure safe design and operation for operators and the surrounding environment.
Because hazards may arise not only from the operation of individual machines, but also from their interaction. The standard emphasizes a holistic approach: risk assessment and protective measures must cover the entire system.
This means defining the system’s physical and operational limits and the interfaces between machines. It is essential for proper risk assessment and for designing appropriate safeguards.
So that operators can perform tasks in clearly defined, marked, and protected areas. These zones should be equipped with appropriate protective measures, such as guards, presence detection, and interlocks.
This verifies whether the safeguards effectively reduce risk to an acceptable level, including through functional testing, documentation review, and compliance audits against harmonized standards. It is identified as an essential element, among other things, for obtaining the CE mark.