- Essential safety requirements are defined in Annex I of the Machinery Directive.
- The design takes place via harmonized standards.
- The presumption of conformity is linked to the application of these harmonized standards.
- The application of the standard is voluntary. Deviating solutions are possible.
- Approvals or permits from the authorities for placing the product on the market are basically not necessary.
- The manufacturer produces a declaration of conformity; a third-party certificate is not required.
- The product is designated with the CE mark, not with the test mark.
- There is only an obligation to involve a third party (“notified body”) for certain risk products.
- The role of the state is limited to market surveillance.
What is functional safety?
As a developer and manufacturer of intelligent systems, you face a major challenge. Any system, no matter how well thought out, poses serious risks to its immediate environment. The standards and directives governing functional safety (fusa) ensure reliable protection for people, the environment, and machinery. They describe how to manage risks by means of automated safety systems. The correct application of the safety-related (control) systems and other risk-minimizing measures are crucial for the safety of a system. In this case, if a critical error occurs, the controller initiates the safe state.
Functional safety operates in a legally regulated environment. EN ISO 13849-1 is one of the most important standards for machine building. This regulates which safety requirements a machine must fulfill. The IEC 61511 series of standards governs the application of the functional safety of systems in the process industry. Important parameters for the reliability of safety-related functions are the safety integrity level (SIL) and the performance level (PL).
Machinery Directive Requirements for safety of machinery in the European Economic Area
Do your products fall within the scope of Machinery Directive 2006/42/EC? Do you want to place them on the European internal market? If so, you must observe the requirements of the Machinery Directive. It is only when these requirements are met in full that machines are allowed to bear the CE marking. This marking is required in order for a machine to be placed on the market and operated in the European Economic Area.
Safety of machinery worldwide Legislation in various regions of the world
- Essential obligatory occupational safety laws are described in the OSHA (Occupational Safety and Health Administration) standards which are directed at the operator.
- Requirements for the manufacturers of machinery and safety components result indirectly from the OSHA standards.
- ANSI standards are very often called on for product liability cases in the context of civil law suits.
- Although the application of ANSI standards is not legally mandatory, they have a “quasi obligatory” character due to civil law contracts.
- In many cases, ANSI and UL standards deviate from international or European standards.
- There is no governmental market surveillance in the USA. A test mark from an NRTL (Nationally Recognized Testing Laboratory) is necessary for the commissioning of a plant.
- There is still no pronounced market surveillance, but there are checks by the customs authorities.
- Many international standards have been adopted into the Chinese regulations concerning the safety of machinery, but are not always up to date.
- Machines do not have to be CCC-certified, but this is necessary for central machine components.
- In addition to the national standards and industry standards, there are also numerous regional standards and company-internal standards.
- There exist legal regulations for the import of goods [Lei N° 8078 Art. 8] and indirectly for machinery and components [NR12 § 12.134].
- At the moment, there is no general obligatory certification. Obligatory certification for certain safety products is expected in the future.
- Certifications by European and American institutes and authorities are only accepted in the context of mutual acknowledgments.
- Factory inspections (even unannounced) are possible for control purposes.
- International standards can only be applied if no national standards are available. In some instances, these national standards have more stringent requirements than the international standards.
- If there is an immediate and high risk for workers, an immediate operational and sales ban can be declared.
Process reliability Compliance with current legal requirements
In the process industry, there are different potential hazards for people and the environment. To minimize these hazards, the requirements from IEC 61511 should be met. IEC 61511 provides for functional safety management to prevent systematic errors. To control random errors, the safety functions must be designed correctly. In addition, the requirements of explosion protection must be observed. Increasing confinement by legislation and the growing number of safety regulations require an understanding of the fundamentals of explosion protection.
The way to a safe process plant Implementation of functional safety management
The safety lifecycle illustrates the process:
A detailed and well-documented risk analysis is the foundation for producing a safe process plant. Based on this, the following documents can then be created in the individual phases:
- Safety Requirements Specification
- Design of the hardware and SIL assessment
- Software documentation
- Validation of the safety functions
If these phases are passed through without planning and without a suitable management system, systematic errors can creep in. These errors may go undetected until a hazard occurs. Therefore, the path to a safe process plant starts before the risk analysis (incl. HAZOP). To avoid systematic errors during the individual phases, plant manufacturers and operators need a functional safety management system.
Security consulting From risk assessment to the certified system
For you as a manufacturer, integrating safety functions into machinery and plants involves additional work. Phoenix Contact will lend support here by providing advice tailored to your requirements. Regardless of manufacturer, the TÜV-certified functional safety experts at Phoenix Contact are on hand to assist you with the planning, construction, modification, completion, and operation of machinery throughout the safety lifecycle.
Products for functional safety From the safety switch to the safe controller
Discover our comprehensive range of products and solutions for functional safety. Safety switches, safety relays, and safe controllers enable the easy startup and configuration of your system. This means that you can concentrate on your core capabilities, safe in the knowledge that the statutory requirements will be satisfied and safe operation of your system ensured.