What is work equipment and why is it regulated?
Machinery and equipment are the source of a significant number of serious and fatal accidents: entrapments, crushing injuries, cuts, electrical contacts, rollovers, falls from elevated equipment, and projectiles. The European Union regulated this matter with a dual approach: marketing regulations, aimed at manufacturers, which ensure that new machinery is designed and manufactured safely and bears the CE marking; and operating regulations, aimed at employers, which ensure that equipment, whether new or old, is selected, installed, used, and maintained safely throughout its useful life. Royal Decree 1215/1997 is the Spanish standard for operating machinery.
The concept of work equipment is deliberately broad to ensure that no means of work are excluded. The standard establishes general obligations (Article 3), checks (Article 4), information and training (Article 5), and consultation of workers (Article 6), and two annexes: Annex I with the minimum provisions applicable to equipment (general, mobile, and lifting equipment) and Annex II with the provisions relating to its use (general, mobile equipment, lifting equipment, and temporary work at height, the latter incorporated by Royal Decree 2177/2004).
Equipment marketed with CE marking is presumed to comply with the requirements of Annex I; equipment manufactured before 1995 should have been adapted to these minimum requirements before 1998, and retrofitting older equipment remains one of the most frequent preventive tasks in industry. The INSST Technical Guide for the assessment and prevention of risks related to the use of work equipment, updated in 2021, provides the application criteria.
Main obligations of the employer
- Appropriate choice. Select equipment taking into account the conditions and characteristics of the work, the risks present at the site and the additional risks that the equipment itself may generate, and adapt the equipment when full safety cannot be guaranteed.
- Compliance with Annex I. Ensure that the equipment meets the minimum requirements: safe operating mechanisms, emergency stop, protection against moving parts, falls and projections, stability, lighting, temperatures, alarms, energy isolation and signaling.
- Checks. Initial check after installation and before commissioning, periodic checks and tests when safety depends on installation conditions or deterioration, and check after exceptional events (transformations, accidents, long periods of inactivity), documented and kept.
- Maintenance. Keep equipment in safe condition throughout its useful life, according to the manufacturer’s instructions, with records and a maintenance log where available.
- Use in accordance with Annex II. Installation and use in accordance with the instructions, prohibition of unforeseen uses, rules for self-propelled mobile equipment, for lifting loads and people, and for temporary work at height.
- Information and training. Understandable written instructions on conditions of use, abnormal situations and lessons learned; specific training and, where applicable, authorization for workers using equipment with specific risks.
- Consultation and participation. Consultation with workers on the choice of equipment and conditions of use, in accordance with Law 31/1995.
Relationship with machinery regulations
- CE marking and declaration of conformity. Manufacturers must comply with the essential health and safety requirements, prepare the technical file and the declaration of conformity, affix the CE marking and provide the instruction manual (Royal Decree 1644/2008; Regulation (EU) 2023/1230 applicable from January 2027).
- Presumption of conformity. Equipment with CE marking is presumed to conform to Annex I of Royal Decree 1215/1997, without prejudice to the employer’s duty to verify its suitability for use and location.
- Substantial modifications. Anyone who substantially modifies a machine or builds one for their own use assumes the obligations of the manufacturer.
- Older machinery. Equipment manufactured before the Machinery Directive must comply with Annex I through documented technical adaptation, without CE marking.
- Harmonized standards. The UNE-EN ISO 12100, UNE-EN ISO 13849 standards and the type C standards for machine families guide the design and adaptation.
Organizational application: how to manage work equipment
- Inventory all equipment with its data (manufacturer, year, CE marking or suitability, manual, location, users) and classify them according to their risks.
- Evaluate the suitability of each piece of equipment to Annex I and its intended use, and plan the adaptation of old or modified equipment with priority according to risk.
- Define the program of initial, periodic and after exceptional events checks, with competent responsible parties and records.
- Establish preventive maintenance according to the manufacturer’s instructions and the energy lockout/tagout procedure for interventions.
- Prepare instructions for use by equipment and train and authorize users of equipment with specific risks (trucks, platforms, overhead cranes, dangerous machines).
- Integrate the purchase and modification of equipment into change management, with consultation with representatives and verification of manufacturer documentation.
- Investigate equipment incidents and review assessments and instructions when failures or unintended uses are detected.
Preventive management software allows you to maintain an inventory of equipment with its documentation, plan and record checks and maintenance, manage usage authorizations, and link incidents to each piece of equipment.
Limits and common mistakes
- Assuming that the CE marking guarantees safety in any use and place, without evaluating the suitability of the equipment for the job.
- Maintaining use of old equipment without documented compliance with Annex I.
- Disabling or bypassing safety guards and devices, or modifying equipment without assessing the consequences.
- Skipping periodic checks or failing to retain the results.
- Allowing the use of equipment with specific risks by personnel without training or authorization.
- Lack of energy allocation procedures for maintenance and cleaning interventions.
Detailed requirements can be found in the annexes of Royal Decree 1215/1997 and in the INSST technical guide; this sheet is for informational purposes only.
Practical example
Situation: A plastic processing company with 70 injection molding machines, extruders and peripherals from different eras wants to organize its equipment management.
- Inventory. It records the 70 machines with year, CE marking or absence, available manuals and users, and detects twelve injection molding machines prior to 1995 without evidence of suitability.
- Adaptation. Evaluate the twelve machines against Annex I with the support of the prevention service and an installer, prioritize by risk of entrapment in molds and carry out the adaptation (interlocked guards, emergency stop, signage) with a documented report.
- Operation. Instructions for use per machine, lockout procedure for mold changes and cleaning, operator training and authorization, and periodic check plan.
- Monitoring. Recording of checks, maintenance and incidents in the management system and annual review of the inventory and pending adjustments.
Regulatory and reference framework
- Royal Decree 1215/1997, of July 18. Minimum health and safety requirements for the use of work equipment by workers.
- Royal Decree 2177/2004, of November 12. Amendment of Royal Decree 1215/1997 regarding temporary work at height.
- Royal Decree 1644/2008, of 10 October . Rules for the marketing and commissioning of machinery (transposition of Directive 2006/42/EC).
- Technical guide for the assessment and prevention of risks related to the use of work equipment (INSST, 2021) . Criteria for the application of Royal Decree 1215/1997.
- ISO 12100:2010 . Safety of machinery: General principles for design, risk assessment and reduction.
Directive 2009/104/EC codifies Directive 89/655/EEC on the use of work equipment; Regulation (EU) 2023/1230 on machinery will replace Directive 2006/42/EC from January 2027.
