Machinery Directive Compliance in European Union (EU / EEA)
Essential Requirements
| Article | Requirement |
|---|---|
| Essential Requirements | Harmonised standards |
Conformity Assessment
Module A for machinery not listed in Annex IV. Annex IV machinery requires Module B+C, D, E, F, G, or H — Notified Body mandatory for Annex IV.
Harmonised Standards
Applying these standards creates a presumption of conformity with the applicable essential requirements.
| Standard |
|---|
| EN 415-3 |
| EN 474-1 |
| EN 60204-1 |
| EN ISO 10218-1 |
| EN ISO 12100 |
| EN ISO 13849-1 |
| EN ISO 13849-2 |
| EN ISO 13850 |
| EN ISO 13856-1 |
| EN ISO 13857 |
| EN ISO 14120 |
| EN ISO 19085-1 |
| EN ISO 4254-1 |
Required Testing & Evidence
Industrial robot safety
Industrial robot standards (ISO 10218 series) require specific safety function and risk assessment for robotic systems.
Typical artifacts: Robot safety design file, collaborative operation assessment, validation of robot-specific safety functions.
Machinery electrical safety
Machinery standards (EN 60204-1) specify electrical equipment safety requirements.
Typical artifacts: Electrical safety test reports, wiring diagrams.
Machinery risk assessment
Machinery standards (ISO 12100) require a documented risk assessment process.
Typical artifacts: Risk assessment report, risk reduction records.
Machinery safety-related control systems
Machinery standards require design and validation of safety-related control system functions.
Typical artifacts: Safety function design file, validation report, PL/SIL calculations.
Co-Applicable Legislation
Products in scope of this legislation may also need to comply with the following:
Data sourced from official EU legislation and the Official Journal. Verify current status before placing products on the market.
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