Machinery · Hazloc Labs

ISO 12100 Risk Assessment for Machinery CE Files

ISO 12100 defines general principles for machinery risk assessment and risk reduction. For EU machinery compliance, a structured risk assessment is not optional paperwork — it drives which standards, safeguards, and residual-risk warnings belong in your file and manual.

The assessment loop

1. Determine machine limits (use, space, time, users)
2. Identify hazards (mechanical, electrical, thermal, noise, ergonomic, control-system, etc.)
3. Estimate and evaluate risk
4. Reduce risk by inherently safe design, safeguarding, and information for use — in that preference order
5. Iterate until residual risk is acceptable

What good documentation looks like

• Hazard list tied to life-cycle phases (transport, installation, operation, maintenance, decommissioning)
• Risk scoring method stated and applied consistently
• Protective measures mapped to specific hazards
• References to type-C standards (e.g. robot, press, conveyor standards) where used
• Residual risks called out in the instructions

Link to self-certification

If you are on a manufacturer conformity route, the ISO 12100-based assessment is often the spine of your defense. See self-certification vs Notified Body and our Machinery Regulation overview.

FAQ

Is a spreadsheet enough?

A clear, maintained spreadsheet can work if hazards, scores, measures, and owners are complete. Vague one-page “risks are mitigated” statements fail audits.

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