CE Marking
Support, Risk Assessment & Technical File
SST supports manufacturers, integrators and machine designers throughout the entire CE conformity process, ensuring compliance with the essential safety requirements defined by Directive 2006/42/EC and the new Regulation (EU) 2023/1230.
The transition to the new regulations presents an opportunity to make business processes safer, more efficient and more competitive.
Find out howRegulatory compliance analyses
In accordance with Directive 2006/42/EC and the new Regulation (EU) 2023/1230:
- Identification of applicable Directives and Technical Standards (harmonised and non harmonised).
- Review of existing technical documentation (drawings, layouts, manuals, component certificates).
- Detection of non conformities and definition of corrective actions.
On site machine inspection
Both during the design phase and the finalisation phase:
- Verification of fixed and movable guards, protective devices and interlocks.
- Analysis of control systems and installed safety devices.
- Collection of technical data required for risk assessment and Technical File preparation.
Risk Assessment
In accordance with the provisions of the UNI EN ISO 12100 standard:
- Identification of mechanical, electrical, thermal, ergonomic and functional hazards.
- Risk estimation (severity, frequency, possibility of avoidance).
- Definition of inherent, technical and organisational protective measures.
- Evaluation of residual risks and recommendations for their mitigation through procedures and training.
Technical File
Prepared or incorporated in accordance with the requirements of the Directive and the Regulation, including:
- General description of the machine.
- Drawings, diagrams and layouts.
- Risk assessment.
- Calculations, verifications and test results.
- Instruction manual.
- Component declarations and certificates.
- Documentation produced during the conformity assessment.
Safety Functions
In accordance with the provisions of the UNI EN ISO 13849-1 standard (PL, PLr and CCF):
- Determination of required Performance Levels (PLr) for each safety function.
- Modelling of control circuits using Sistema software and calculation of achieved PL.
- Verification of MTTFd, DCavg, categories and architectures.
- Evaluation of Common Cause Failure (CCF) measures according to Annex F.
- Delivery of a complete technical report.
Tackle the new Machinery Regulation
with the right support.
We analyse your needs and work with you to identify the most effective approach for your business, through
targeted training and specialist consultancy.