Safety and conformity in industrial machine design: a technical and regulatory requirement

Safety standards: a structuring regulatory base

In Europe, the design of industrial machines is governed by CE marking, currently framed by Directive 2006/42/EC (replaced by Machinery Regulation 2023/1230 applicable from January 2027).

"A compliant machine is not one simply equipped with an emergency stop, but one that reduces risk at source, by design."

A safety-integrated design approach

At SEMSO, safety is integrated right from the functional definition phase. Every project goes through a systematic risk analysis according to EN ISO 12100:

• Identification of sources of danger (mechanical, electrical, thermal, ergonomic)
• Evaluation of severity, frequency of exposure, and avoidability
.
• Definition of risk reduction measures through intrinsic design, technical devices and information

Example: on a product stacker/unstacker, safety is ensured by:

• Presence sensors at the bottom of the stroke for immediate stop
.
• Transparent removable housings with electromagnetic locking
• Safe grippers with stop in case of pressure loss

Automation and control: the critical role of functional safety

Functional safety (Safety) is based on the integration of redundant architectures capable of handling failures without danger to the operator. SEMSO uses certified safety PLCs (Pilz, Siemens, Sick) integrated into the communication bus to:

• Continuously monitor access areas
.
• Detect position/speed/time inconsistencies
• Guarantee safe stopping (STO, SS1) according to required PL level

A station with a collaborative robot can thus be equipped with a safety scanner to slow down or stop movement depending on operator distance, in compliance with ISO TS 15066.

Validation, documentation and CE conformity

CE marking is based on a structured technical file. SEMSO systematically provides:

• The user and maintenance manual
• The CE declaration of conformity
• The risk analysis report
• Electrical, pneumatic and mechanical drawings

These documents guarantee the manufacturer traceability, control of compliance in the event of an audit, and regulatory transfer capability in large groups or demanding environments (pharmaceutical, food processing).