Machine safety

What is machine safety?

Machines concentrate mechanical, electrical, hydraulic, pneumatic, and thermal energies that can cause entrapment, crushing, cuts, projections, burns, electrical contact, and exposure to noise, vibrations, or hazardous substances. Machine safety is based on a principle of integration: risks must be eliminated or reduced in the design phase, then through protection (guards and protective devices), and finally through user training, in that order. Technical standards formalize this in UNE-EN ISO 12100, which describes the process of risk assessment and reduction.

The manufacturer must carry out a risk assessment of the machine, comply with the essential requirements of Annex I of Directive 2006/42/EC, prepare the technical file, draft the instruction manual, sign the EC declaration of conformity, and affix the CE marking. For certain higher-risk machines (Annex IV), conformity assessment requires the involvement of a notified body or the application of harmonised standards that cover all requirements.

The business owner using the machine must verify that it has the CE marking, declaration, and manual, install and use it according to the instructions, maintain it, carry out checks, and train users. Machines manufactured before 1995 or substantially modified require specific analysis: the former must comply with Annex I of Royal Decree 1215/1997, and the latter may be considered new machines for the purposes of marketing regulations.

The new Regulation (EU) 2023/1230

• Nature and application. Regulation directly applicable in all Member States, replacing Directive 2006/42/EC and applying, in general, from 20 January 2027; until then the directive and Royal Decree 1644/2008 remain in force.
• Main updates. Expansion to related products and substantial modifications, cybersecurity requirements and systems with self-evolving behavior (machine learning), possibility of instructions in digital format with conditions, and a new list of high-risk machines in Annex I that requires third-party assessment for some categories.
• Obligations of economic operators. Manufacturers, authorized representatives, importers and distributors have differentiated obligations regarding traceability, information and cooperation with market surveillance authorities.
• Continuity of principles. Essential health and safety requirements, CE marking, declaration of conformity and the role of harmonised standards are maintained.

Machine protection measures

• Guards. Fixed, mobile with interlocking or locking, adjustable and self-adjusting, dimensioned according to the safety distances of the technical standards.
• Protective devices. Two-hand controls, immaterial barriers, sensitive mats, validation and emergency stop devices, with a level of performance or integrity appropriate to the safety function.
• Control and operating mechanisms. Visible, identifiable, safe operation of start-up, general and emergency stop, prevention of accidental start-up.
• Energy and maintenance. Energy separation and dissipation, lockout /tagout , operating modes with reduced protections for adjustment and maintenance under controlled conditions.
• Information and training. Instruction manual, signage, warnings on the machine and specific training for operators and maintenance personnel.

Organizational application: how to manage machine safety

1. Inventory all machines with date of commissioning, CE marking, declaration of conformity, manual and modifications made.
2. Evaluate each machine against Annex I of Royal Decree 1215/1997 and the risks of its actual use, including adjustments, cleaning and maintenance.
3. Adapt machines manufactured before 1995 or without markings with compliant guards and devices, documenting the adaptation.
4. Establish the procedure for purchasing machines with safety requirements, reception and initial check before commissioning.
5. Define the procedures for lockout, permits and maintenance methods, and train operators and maintenance personnel on each machine.
6. Plan periodic checks of safety devices and record the results.
7. Manage machine modifications as changes with prior evaluation, and analyze whether they constitute a substantial modification.

Preventive management software allows you to maintain the inventory of machines with their documentation, checks, associated training and work permits, and link it with risk assessment and change management.

Limits and common mistakes

1. Assuming that the CE marking guarantees safety under any conditions of use; the user must evaluate the specific use.
2. To bypass or circumvent guards and protective devices to increase productivity or facilitate adjustments.
3. Modifying machines without assessing whether the modification is substantial and without updating the documentation.
4. Intervening in machines that are running or without energy allocation during maintenance.
5. Confusing marketing regulations (manufacturer) with usage regulations (business).
6. Apply Regulation (EU) 2023/1230 before its application date or ignore its transitional arrangements.

The specific requirements for each machine depend on its type, the applicable harmonized standards and the risk assessment, and must be verified by competent technicians.

Regulatory framework in Spain and the European Union

• Royal Decree 1644/2008, of 10 October . Rules for the marketing and commissioning of machinery, transposition of Directive 2006/42/EC.
• Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023. Machinery Regulation, generally applicable from 20 January 2027.
• Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006. Machinery Directive in force until the application of the regulation.
• Royal Decree 1215/1997, of July 18. Use of work equipment by workers.
• INSST technical guide on work equipment . Criteria for the application of Royal Decree 1215/1997.

Harmonised technical standards (UNE-EN ISO 12100 series, UNE-EN ISO 13849, UNE-EN ISO 13857, among others) give a presumption of conformity with the essential requirements when applied in full.