ENBRA - Ingeniería en Automatización y Seguridad Industrial

Machine Safety

Specialized services in functional safety of industrial machinery according to current European standards.

EN ISO 12100:2010EN ISO 13849-1:2015EN 62061:2021Directive 2006/42/EC

Specialized Services

Complete coverage of your machinery lifecycle, from initial assessment to final certification.

EN ISO 12100:2010

Risk Assessment and Hazard Analysis

Systematic and personalized analysis in compliance with Machinery Directive 2006/42/EC. Structured evaluation of hazards in all phases of the machine lifecycle, from design to decommissioning.

Metodología: We apply iterative methodology in 3 phases: systematic identification, quantitative estimation and residual risk evaluation.

Características técnicas:

Determination of machine limits and applicable standards
Systematic identification of hazards and hazardous situations
Risk estimation (damage severity + probability of occurrence)

Entregables:

Structured Risk Assessment Report
Quantified risk matrix with priority levels
Prioritized list of risk reduction measures
Ver Detalles
EN ISO 13849-2:2012

Safety System Validation

Complete technical validation of safety-related parts of control systems (SRP/CS) through documentary analysis, physical inspection and functional testing according to EN ISO 13849-2 principles and methods.

Metodología: Structured process: planning → validation by analysis → validation by testing → documentation.

Características técnicas:

Validation by analysis: technical review of documentation and design
Validation by testing: functional tests and fault behavior
Verification of safety parameters (MTTFd, DC, CCF, etc.)

Entregables:

Detailed and specific validation plan
Test protocols and documented results
Complete technical validation report
Ver Detalles
EN ISO 13849-1:2015

Performance Level (PL/PLr) Calculation

Precise determination of required Performance Level (PLr) according to risk analysis and calculation of achieved Performance Level (PL) through quantitative methods for safety systems.

Metodología: Quantitative approach: PLr determination → architecture design → PL calculation → compliance verification.

Características técnicas:

PLr determination using risk matrix (S, F, P)
Analysis and design of safety architectures (Cat. B, 1, 2, 3, 4)
Quantitative calculation of achieved PL (simplified and detailed methods)

Entregables:

Detailed PLr calculation according to EN ISO 13849-1 methodology
Safety block diagrams with categories
Technical parameter tables (MTTFd, DC, CCF)
Ver Detalles
Directive 2006/42/EC

CE Marking - Machinery Directive

Complete process for CE marking of machinery in compliance with Directive 2006/42/EC. Preparation of technical file, declaration of conformity and documentation for commercialization in the European market.

Metodología: Systematic process: applicability analysis → technical file → CE declaration → marking.

Características técnicas:

Analysis of directives and regulations applicable to the machine
Preparation of technical file according to Annex VII
Drafting of CE Declaration of Conformity

Entregables:

Complete technical file according to Machinery Directive
Signed CE Declaration of Conformity
Instruction manual in required languages
Ver Detalles

Our Process

Structured methodology that ensures regulatory compliance and optimization of your safety systems.

01

Initial Analysis

Detailed study of your machinery, processes and applicable standards.

02

Technical Assessment

Systematic hazard identification and quantitative risk evaluation.

03

Implementation

Development and implementation of optimized safety measures.

04

Validation

Complete verification and documentation for regulatory compliance.

Why Choose ENBRA?

Over 15 years of experience in machine safety with a technical and personalized approach.

Regulatory Framework

EN ISO 12100:2010

General principles for design. Risk assessment and risk reduction.

EN ISO 13849-1:2015

Safety-related parts of control systems. General principles for design.

EN 62061:2021

Functional safety of electrical, electronic and programmable electronic control systems.

Application Sectors

Automotive
Energy
Food
Pharmaceutical
Construction
Packaging

Our Guarantees

100% regulatory compliance
Complete technical documentation
Post-delivery support
Certified technical expertise
Guaranteed delivery times