Overview
EN ISO 13849-2:2012 - Safety of machinery - Safety-related parts of control systems - Part 2: Validation (ISO 13849-2:2012) specifies the procedures and conditions for validating safety functions, the category, and the performance level (PL) achieved by safety-related parts of a control system (SRP/CS) designed per ISO 13849-1. The standard defines validation by analysis and testing, and includes requirements for planning, documentation and evidence needed to demonstrate compliance and functional safety.
Key topics and technical requirements
- Validation process and principles: Establishes a validation plan, inputs and required records for SRP/CS validation.
- Validation plan and records: Specifies what information to include (scope, methods, acceptance criteria, responsibilities) and how to maintain a validation record.
- Analysis techniques: Guidance on analytical methods for proving behaviour under normal and fault conditions.
- Testing requirements: When and how to perform tests, including measurement accuracy, number of test samples and more stringent test cases.
- Fault lists: Generic and specific fault lists to support systematic validation and fault exclusion reasoning.
- Performance metrics: Validation of MTTFd (mean time to dangerous failure), diagnostic coverage (DC), and common-cause failures (CCF) as they relate to achieving a PL or category.
- Systematic capability: Validation of measures against systematic failures, including validation of safety-related software.
- Combination and integration: Rules for validating combinations of safety-related parts and verifying the achieved PL/category for the whole SRP/CS.
- Environmental and maintenance requirements: Validation of environmental conditions and maintenance provisions that affect SRP/CS performance.
- Informative annexes: Practical validation tools and well-tried components for mechanical, pneumatic, hydraulic and electrical technologies; plus example fault/diagnostic validation.
Practical applications and users
Who uses EN ISO 13849-2:2012:
- Machine designers and OEMs validating SRP/CS designs to achieve a required PL
- Functional safety engineers conducting analysis and testing campaigns
- Control system integrators implementing fault-detection and diagnostic measures
- Regulatory and compliance teams demonstrating conformity with the EU Machinery Directive (2006/42/EC) - Annex ZA links the standard to the Directive
- Notified bodies and assessors evaluating validation evidence for CE marking
- Maintenance and quality teams ensuring ongoing validity after modifications or repairs
Practical value:
- Provides a structured validation workflow (plan → analysis → testing → record) to demonstrate that safety functions meet required PLs and categories.
- Supplies technology-specific guidance (annexes) to streamline validation for mechanical, pneumatic, hydraulic and electrical systems.
Related standards
- ISO 13849-1 - General principles for design of safety-related parts of control systems (partner document)
- ISO 12100 - General principles for risk assessment and design (type‑A foundational standard)
- EU Machinery Directive 2006/42/EC - EN ISO 13849-2 supports presumption of conformity when cited in the Official Journal
Keywords: EN ISO 13849-2:2012, validation, safety-related parts of control systems, SRP/CS, performance level, PL, category, ISO 13849-1, machinery safety, validation by analysis and testing.
