An operational view of the documents, safety functions and validation points to prepare when a machine is modified or integrated.
Regulation (EU) 2023/1230 on machinery will apply from 20 January 2027 and replace Directive 2006/42/EC. The practical challenge is not to “do CE” at the end, but to build safety, documentation and validation into the project from the concept stage.
1. Start from intended use and real interventions
Safety work should reflect the real machine lifecycle: production, setup, cleaning, jam clearing, changeover, maintenance, troubleshooting and recovery after faults. Many hazards appear in transient modes rather than during the nominal automatic cycle.
2. Document the risk assessment
ISO 12100:2010 remains a central reference for hazard identification, risk estimation and risk reduction methodology. The expected output is not just a hazard list, but a traceable chain from identified risk to reduction measure, safety function where relevant, and validation evidence.
3. Define safety functions before wiring
For safety-related parts of control systems, ISO 13849-1:2023 provides design and integration methodology. In practice each safety function should state the trigger, expected safe state, restart conditions, required performance, architecture and validation method.
4. Treat electrical design as part of the safety system
IEC 60204-1:2016+A1:2021 covers general requirements for the electrical equipment of machines. A robust file depends on consistency between drawings, wire marking, protection, control circuits, emergency stops, drives and maintenance documentation.
- Updated risk assessment
- Safety-function list and restart conditions
- PLr / architecture / validation where applicable
- Electrical drawings consistent with the cabinet
- Component and cable identification
- Documented FAT / SAT tests
- Updated instructions and safety information
5. CE marking is not a “quality certificate”
Under the Machinery Regulation, the manufacturer must establish technical documentation, apply the relevant conformity-assessment procedure, draw up the EU declaration of conformity and affix the CE marking. A CE logo on an individual component therefore does not demonstrate conformity of the final integration.
Official references
- Regulation (EU) 2023/1230 — EUR-Lex ↗
- ISO 12100:2010 — ISO ↗
- ISO 13849-1:2023 — ISO ↗
- IEC 60204-1:2016+A1:2021 — IEC ↗
General technical scoping note. Regulatory applicability, performance and responsibilities must be confirmed project by project.
