Risk Assessment for Robotic Systems: From ISO 12100 to IEC 61508

By Cody Smith

Untitled design (32)
Introduction 

For designers of robotic systems seeking IEC 61508 certification, performing a thorough risk assessment according to ISO 12100 is a crucial first step. This article guides you through the process, providing practical examples relevant to robotic applications. 

Understanding the Relationship 

Before diving into the risk assessment process, it's important to understand how ISO 12100 and IEC 61508 complement each other: 

  • ISO 12100 provides the foundational methodology for identifying hazards and assessing risks 

  • IEC 61508 builds upon this by specifying requirements for electrical/electronic/programmable electronic (E/E/PE) safety-related systems 

The Risk Assessment Process  
Screenshot 2025-05-20 162604

Figure 1: Risk Assessment Process 

Step 1: Define the Limits of the Machinery 

Consider all phases of the robotic system's lifecycle, including: 

  • Physical limits (range of motion, speed, force) 

  • Time limits (expected lifetime, maintenance intervals) 

  • Use limits (intended operation modes, user interactions) 

Example: For a collaborative robot arm in a manufacturing cell: 

  • Physical: 1.4m reach, 15kg payload, 1.5 m/s maximum speed 

  • Time: 10-year expected lifetime, quarterly maintenance 

  • Use: Pick-and-place operations, direct human interaction during teaching 

Step 2: Hazard Identification 

Systematically identify all potential hazards, considering: 

  • Mechanical hazards (crushing, shearing, impact) 

  • Electrical hazards 

  • Thermal hazards 

  • Control system failures 

Example: For our collaborative robot: 

  • Crushing hazard between robot arm and fixed objects 

  • Impact hazard during unexpected movements 

  • Electrical hazard from exposed terminals during maintenance 

  • Control system failure leading to uncontrolled motion 

Step 3: Risk Estimation 

For each hazard, estimate: 

  1. Severity of potential harm 

  2. Probability of occurrence, considering: 

  3. Exposure frequency 

  4. Probability of hazardous event 

  5. Possibility of avoidance 

Example Risk Estimation Matrix: Severity levels: 

  • S1: Minor injury (reversible) 

  • S2: Serious injury (irreversible) 

  • S3: Death 

Probability levels: 

  • P1: Rare 

  • P2: Possible 

  • P3: Likely 

Step 4: Risk Evaluation 

Determine if risk reduction is required based on the estimated risk level. This evaluation will feed directly into your IEC 61508 safety requirements. Example: For a crushing hazard between robot and workpiece: 

  • Severity: S2 (potential for serious injury) 

  • Probability: P2 (possible during normal operation) 

  • Result: Risk reduction required 

Risk Reduction Measures  

Three-Step Method

Inherently Safe Design Measures: 

  1. Eliminate pinch points through design 

  2. Reduce maximum force/speed capabilities 

  3. Implement mechanical stops 

  4. Use fail-safe principles 

Example: For a collaborative robot: 

  • Design rounded edges and smooth surfaces 

  • Limit joint torques through mechanical design 

  • Implement backdrivable joints 

Safeguarding and Complementary Protective Measures: 

  • Guards and protective devices 

  • Emergency stop systems 

  • Safety-rated monitored stop 

  • Speed and separation monitoring 

Example:  

  • Safety laser scanner for presence detection 

  • Pressure-sensitive mats in work area 

  • Two-hand control devices for dangerous operation 

 Information for Use: 

  • Warning signs and signals 

  • Operating procedures 

  • Training requirements 

  • Maintenance instructions 

SIL Determination Process 

Step 1: Consequence Analysis 

Evaluate the consequence of hazardous events: 

  • C1: Minor injury 

  • C2: Serious permanent injury to one or more persons; death to one person 

  • C3: Death to several people 

  • C4: Very many people killed 

Step 2: Frequency and Exposure Time 

Assess frequency of exposure: 

  • F1: Rare to more often 

  • F2: Frequent to continuous 

Step 3: Possibility of Avoiding Hazard 

Consider avoidance factors: 

  • P1: Possible under specific conditions 

  • P2: Scarcely possible 

Step 4: Probability of Unwanted Occurrence 

Evaluate probability: 

  • W1: Very slight probability 

  • W2: Slight probability 

  • W3: Relatively high probability 

SIL Assignment Example 

For a robot emergency stop function: 

  • Consequence: C2 (potential death) 

  • Frequency: F2 (frequent exposure) 

  • Possibility of avoidance: P2 (rarely possible) 

  • Probability: W2 (slight) Result: SIL 2 requirement 

Risk Reduction Verification 

For each implemented measure: 

  1. Verify effectiveness 

  2. Ensure no new hazards introduced 

  3. Document validation results 

  4. Update risk assessment 

Example verification methods: 

  • Functional testing of safety systems 

  • Measurement of stopping times 

  • Validation of safety distances 

  • Testing of protective devices 

Documentation and Implementation 

Required Documentation 

Risk Assessment Report: 

  • Machinery specifications 

  • Hazards identified 

  • Risk estimation results 

  • Risk reduction measures 

  • Residual risks 

Safety Requirements Specification: 

  • Safety functions 

  • SIL requirements 

  • Operating modes 

  • Response times 

  • Error handling 

Validation Plan: 

  • Test specifications 

  • Acceptance criteria 

  • Validation methods 

  • Test results 

Conclusion 

A thorough ISO 12100 risk assessment provides the foundation for IEC 61508 certification. By following this structured approach and maintaining detailed documentation, you'll be well-prepared for the certification process. Remember that risk assessment is an iterative process - continue to monitor and update your assessment throughout the system's lifecycle. 

Interested in our services?

Contact us or learn more about the services CSA provides

Contact us