Standards and safety in handling technology

What changes from 2027

Machinery Directive 2006/42/EC is replaced by Regulation (EU) 2023/1230, which applies from 20 January 2027. As a regulation it applies directly in all member states without national transposition. Much of the content stays familiar; new elements include requirements for cybersecurity, provisions for machines with self-evolving behaviour and the option of digital instructions – with a paper version still to be supplied on request. For classical handling technology little changes in practice, but the documentation has to be moved onto the new basis.

The standards that actually apply

EN ISO 12100 is the foundation: it describes how a risk assessment is carried out systematically – define limits, identify hazards, estimate risk, evaluate, reduce, re-evaluate. For hand-guided manipulators EN 14238 applies; for non-fixed lifting devices EN 13155. Where control technology with a safety function is involved, EN ISO 13849-1 with its performance level is added.

• EN ISO 12100 – risk assessment and risk reduction
• EN 14238 – hand-guided manipulators
• EN 13155 – non-fixed load lifting attachments
• EN ISO 13849-1 – safety-related parts of control systems
• EN ISO 11228-1 – manual handling: lifting and carrying

The trap: substantial modification

Anyone modifying an existing machine so that a new hazard arises or an existing risk increases carries out a substantial modification – and thereby becomes, in law, the manufacturer of a new machine. That means: own risk assessment, own documentation, own declaration of conformity, own CE marking. A larger gripper, an extended reach or an additional drive can cross that threshold. We therefore document modifications to our units as a matter of course – that is exactly the record that is missing later.

What belongs in the file

The CE mark is the visible tip of documentation that has to be complete: risk assessment, design and manufacturing records, evidence of the standards applied, test reports, operating instructions in the local language and the EU declaration of conformity. These records must be kept for ten years and presented to market surveillance authorities on request. Without them there is no CE – whatever the nameplate says.

Operation is a chapter of its own

The Machinery Regulation governs placing on the market; industrial safety regulations govern operation. As operator you need a risk assessment for the work equipment, defined inspection intervals, a competent person for the inspection, instruction of the operators and the operating instructions at the place of use. These duties do not transfer to the manufacturer, not even under a full-service contract.