Creation of validation plans,
Analysis and evaluation of the performance level
Verification & Validation
Verification according to EN ISO 13849-1
A further point of the required CE documentation is the computational proof of the functional safety of a machine.
We will be pleased to support you in the design of safety functions and take over the verification according to DIN EN ISO 13849-1 for you using the software tool SISTEMA provided by the DGUV.
Validation according to EN ISO 13849-2
In addition to verification, we also offer the validation of functional safety according to EN ISO 13849-2.
Irrespective of the documentation to be supplied, the manufacturer must at all times provide evidence of the functional safety tests according to EN ISO 13849-2. For this purpose, the effort for verification EN ISO 13849-1 (e.g. with the SISTEMA tool) must be done in advance.
We will also be able to take over the validation of the functional safety for you. To be available to you for the acceptance of safety robots (KUKA / ABB), we have also completed appropriate qualification courses.
Retrofit & Changes
In the case of retrofitting or modifications, the question often arises which documentation is required, or even whether the machine must pass through a new EC-conformity procedure. A good tool here is the risk assessment. It allows to evaluate whether new hazards have arisen at all as a result of a conversion and whether a "significant change" has occurred.
If the risk assessment shows that there is no "significant change" it can be used as an applicable document.
If it is a "significant change", the complete machine or assembly must be rebuilt according to the current state of the art and an EC conformity procedure must be carried out in accordance with the Machinery Directive 2006/42/EC, at the end of which a CE marking is awarded.
Interlinking & Integration
In the case of interlinking and integration, there is often confusion at the different parties involved as to which requirements the documentation must fulfil and how areas of responsibility can be clarified.
We will be able to help you with this problem by providing an integration assessment. It is used for hazard identification in the area of "interlinking of machinery". The integration assessment takes into account the requirements resulting from the EC Machinery Directive 2006/42/EC (Machinery Directive) for the consideration of interlinking.
Only when the integration assessment shows that a "assembly of machinery" exists, a complete conformity procedure must be initiated.
Considerations regarding interlinking are based on DIN EN ISO 11161 and DIN EN ISO 12100.
Support during the contract phase
Early agreements of responsibility, documentation requirements and protection concepts ensure a smooth project flow. This creates a fair basis for manufacturers and operators, avoiding project delays during acceptance procedures and high modification costs.
These points should also be included in the tender specifications and performance specifications during the purchasing process. We will be pleased to support you in this.