Machinery
Development of machines, controls and mobile machinery, from concept to CE marking
Machines and plants combine mechanics, drives, electronics and software, from production machines to construction and agricultural machinery. The control system takes on more and more safety functions, and with each function the scope of development grows.
Fixed requirements apply. ISO 13849 and IEC 62061 govern the safety of machine controls, ISO 25119 that of agricultural machinery and ISO 19014 that of earth-moving machinery. The Machinery Regulation replaces the Machinery Directive and additionally requires protection against tampering.
Which requirements apply in machinery
Standards and regulations to be met for machines and their controls.
Safety of the control system
ISO 13849 rates safety functions with performance levels from a to e, IEC 62061 with safety integrity levels. Both require the architecture, diagnostics and reliability of the control system to be demonstrated.
More on functional safety →Mobile machinery
ISO 25119 governs the functional safety of tractors and agricultural machinery, ISO 19014 that of earth-moving machinery. Both work with their own safety levels and their own requirements for development and testing.
More on functional safety →Machinery Regulation
Regulation (EU) 2023/1230 replaces the Machinery Directive. It requires a risk assessment in line with the state of the art, a conformity assessment and CE marking.
More on functional safety →Cybersecurity
Connected machines must be protected against tampering. The Machinery Regulation requires safety-related functions to be secured against it.
More on cybersecurity →When support makes sense
Typical triggers in machinery.
CE marking is coming up
A machine is to be placed on the market, and the risk assessment and the evidence for the safety functions are incomplete.
Performance level open
The required performance level for a safety function has not been determined, and the control system is not designed for it.
Switch to the Machinery Regulation
Existing machines have to be adapted to the new regulation, and the need for changes to the control system and documentation is unclear.
Machine is connected
A machine is connected to a network or a cloud, and the protection against tampering has not been assessed.
What we take on in machinery
Three service areas that can be combined as the task requires.
Engineering
Requirements and control architecture for machines, safety functions and risk assessment to ISO 12100, plus a feasibility assessment before the decision.
More →Management
Project and safety management, quality management and coordination between development, production and conformity assessment.
More →Development and testing
Control software, design of the safety functions to ISO 13849 and IEC 62061, verification and validation, and the technical documentation.
More →Approach and work products
The work follows four steps.
Define machine and use
Intended use, operating environment and limits of the machine are defined, together with the applicable standards and regulations.
Assess risks
The risk assessment determines the safety functions and the required performance level or SIL. Assumptions are documented.
Derive requirements and architecture
The targets lead to safety requirements, control architecture and software requirements, traceable through to testing.
Show the evidence
The safety functions are validated and the technical documentation for the conformity assessment is prepared.
This produces, among other things, the risk assessment, the specification of the safety functions with performance level or SIL, the control architecture, the software requirements, validation reports and the technical documentation. The declaration of conformity and CE marking remain the manufacturer's responsibility, and an assessment by a notified body is not part of it.
Frequently asked questions
What is the difference between ISO 13849 and IEC 62061?
Both standards deal with the functional safety of machine controls. ISO 13849 works with performance levels from a to e, IEC 62061 with safety integrity levels. Which fits better depends on the technology and design of the control system.
What is a performance level?
The performance level (PL) is the level from a to e that states how reliably a safety function must work when a hazard occurs. It follows from the risk assessment and sets the requirements for architecture, diagnostics and components.
What does the Machinery Regulation change?
Regulation (EU) 2023/1230 replaces the Machinery Directive and applies directly in the member states. It adds requirements, for example on protection against tampering and on machines with learning behaviour.
Do ISO 25119 and ISO 19014 apply only to agricultural and construction machinery?
ISO 25119 deals with the functional safety of tractors and agricultural machinery, ISO 19014 with that of earth-moving machinery. ISO 13849 or IEC 62061 apply to other machines.
Does cybersecurity play a role in machinery?
Yes, as soon as a machine is connected. The Machinery Regulation requires safety-related functions to be protected against tampering, and the risk assessment has to take this into account.
Does safety have to be reassessed after a change?
Yes, in the case of substantial modifications to a machine. Whether a change is substantial depends on the individual case and is clarified in the risk assessment.
Clarify your project in a call
In the call we clarify the trigger, which standard applies and which deadline has to be met.