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Understanding ISO 13849: The Foundation of Functional Safety in the Machinery Sector

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The Essential Guide to Requirements Management and Traceability

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The Essential Guide to Requirements Management and Traceability

Chapters
  • 1. Requirements Management
    • Overview
    • 1 What is Requirements Management?
    • 2 Why do you need Requirements Management?
    • 3 Four Fundamentals of Requirements Management
    • 4 Adopting an Agile Approach to Requirements Management
    • 5 Status Request Changes
    • 6 Conquering the 5 Biggest Challenges of Requirements Management
    • 7 Three Reasons You Need a Requirements Management Solution
  • 2. Writing Requirements
    • Overview
    • 1 Functional requirements examples and templates
    • 2 Identifying and Measuring Requirements Quality
    • 3 How to write system requirement specification (SRS) documents
    • 4 The Fundamentals of Business Requirements: Examples of Business Requirements and the Importance of Excellence
    • 5 Adopting the EARS Notation to Improve Requirements Engineering
    • 6 Jama Connect Advisor™
    • 7 Frequently Asked Questions about the EARS Notation and Jama Connect Advisor™
    • 8 How to Write an Effective Product Requirements Document (PRD)
    • 9 Functional vs. Non-Functional Requirements
    • 10 What Are Nonfunctional Requirements and How Do They Impact Product Development?
    • 11 Characteristics of Effective Software Requirements and Software Requirements Specifications (SRS)
    • 12 8 Do’s and Don’ts for Writing Requirements
  • 3. Requirements Gathering and Management Processes
    • Overview
    • 1 Requirements Engineering
    • 2 Requirements Analysis
    • 3 A Guide to Requirements Elicitation for Product Teams
    • 4 Requirements Gathering Techniques for Agile Product Teams
    • 5 What is Requirements Gathering?
    • 6 Defining and Implementing a Requirements Baseline
    • 7 Managing Project Scope — Why It Matters and Best Practices
    • 8 How Long Do Requirements Take?
  • 4. Requirements Traceability
    • Overview
    • 1 What is Traceability?
    • 2 Tracing Your Way to Success: The Crucial Role of Traceability in Modern Product and Systems Development
    • 3 Change Impact Analysis (CIA): A Short Guide for Effective Implementation
    • 4 What is Requirements Traceability and Why Does It Matter for Product Teams?
    • 5 Key Traceability Challenges and Tips for Ensuring Accountability and Efficiency
    • 6 Unraveling the Digital Thread: Enhancing Connectivity and Efficiency
    • 7 The Role of a Data Thread in Product and Software Development
    • 8 How to Create and Use a Requirements Traceability Matrix
    • 9 Traceability Matrix 101: Why It’s Not the Ultimate Solution for Managing Requirements
    • 10 Live Traceability vs. After-the-Fact Traceability
    • 11 How to Overcome Organizational Barriers to Live Requirements Traceability
    • 12 Requirements Traceability, What Are You Missing?
    • 13 Four Best Practices for Requirements Traceability
    • 14 Requirements Traceability: Links in the Chain
    • 15 What Are the Benefits of End-to-End Traceability During Product Development?
  • 5. Requirements Management Tools and Software
    • Overview
    • 1 Selecting the Right Requirements Management Tools and Software
    • 2 Why Investing in Requirements Management Software Makes Business Sense During an Economic Downturn
    • 3 Why Word and Excel Alone is Not Enough for Product, Software, and Systems Development
    • 4 Application lifecycle management (ALM)
    • 5 Is There Life After DOORS®? 
    • 6 Checklist: Selecting a Requirements Management Tool
  • 6. Requirements Validation and Verification
    • Overview
    • 1 Requirements Verification and Validation for Product Teams
    • 2 Best Practices for Verification and Validation in Product Development
  • 7. Meeting Regulatory Compliance and Industry Standards
    • Overview
    • 1 Understanding ISO Standards
    • 2 Understanding ISO/IEC 27001: A Guide to Information Security Management
    • 3 What is DevSecOps? A Guide to Building Secure Software
    • 4 Compliance Management
    • 5 What is FMEA? Failure Modes and Effects Analysis
    • 6 TÜV SÜD: Ensuring Safety, Quality, and Sustainability Worldwide
  • 8. Systems Engineering
    • Overview
    • 1 What is Systems Engineering?
    • 2 The Systems Engineering Body of Knowledge (SEBoK)
    • 3 What is MBSE? Model-Based Systems Engineering Explained
    • 4 Digital Engineering Between Government and Contractors
    • 5 Digital Engineering Tools: The Key to Driving Innovation and Efficiency in Complex Systems
  • 9. Automotive Development
    • Overview
    • 1 Understanding IATF 16949: A Quick Guide to Automotive Quality Management
    • 2 ISO 26262 and Recent Updates: Ensuring Functional Safety in the Automotive Industry
    • 3 A Guide to Automotive Safety Integrity Levels (ASIL)
  • 10. Medical Device & Life Sciences Development
    • Overview
    • 1 The Importance of Benefit-Risk Analysis in Medical Device Development
    • 2 Software as a Medical Device: Revolutionizing Healthcare
    • 3 What’s a Design History File, and How Are DHFs Used by Product Teams?
    • 4 Navigating the Risks of Software of Unknown Pedigree (SOUP) in the Medical Device & Life Sciences Industry
    • 5 What is ISO 13485? Your Comprehensive Guide to Compliant Medical Device Manufacturing
    • 6 What You Need to Know: ANSI/AAMI SW96:2023 — Medical Device Security
    • 7 ISO 13485 vs ISO 9001: Understanding the Differences and Synergies
    • 8 Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know
    • 9 Embracing the Future of Healthcare: Exploring the Internet of Medical Things (IoMT)
  • 11. Aerospace & Defense Development
    • Overview
    • 1 ARP4754A / ED-79A: Enhancing Safety in Aviation Development
    • 2 Understanding ARP4761A: Guidelines for System Safety Assessment in Aerospace
  • 12. Architecture, Engineering, and Construction (AEC industry) Development
    • Overview
    • 1 What is the AEC Industry?
  • 13. Industrial Manufacturing & Machinery, Automation & Robotics, Consumer Electronics, and Energy
    • Overview
    • 1 Functional Safety Made Simple: A Guide to IEC 61508 for Manufacturing
    • 2 Understanding ISO 13849: The Foundation of Functional Safety in the Machinery Sector
    • 3 IEC 62061 – Functional Safety for Machinery Systems
    • 4 IEC 10218: Ensuring Safety in Industrial Robotics
  • 14. Semiconductor Development
    • Overview
    • 1 Why Chiplets Are Changing the Game in Tech Innovation
    • 2 Integrating Digital Engineering and the Digital Thread for Semiconductor Design
  • 15. AI in Product Development
    • Overview
    • 1 Artificial Intelligence in Requirements Management
  • Glossary

Chapter 13: Understanding ISO 13849: The Foundation of Functional Safety in the Machinery Sector

Chapters
  • 1. Requirements Management
    • Overview
    • 1 What is Requirements Management?
    • 2 Why do you need Requirements Management?
    • 3 Four Fundamentals of Requirements Management
    • 4 Adopting an Agile Approach to Requirements Management
    • 5 Status Request Changes
    • 6 Conquering the 5 Biggest Challenges of Requirements Management
    • 7 Three Reasons You Need a Requirements Management Solution
  • 2. Writing Requirements
    • Overview
    • 1 Functional requirements examples and templates
    • 2 Identifying and Measuring Requirements Quality
    • 3 How to write system requirement specification (SRS) documents
    • 4 The Fundamentals of Business Requirements: Examples of Business Requirements and the Importance of Excellence
    • 5 Adopting the EARS Notation to Improve Requirements Engineering
    • 6 Jama Connect Advisor™
    • 7 Frequently Asked Questions about the EARS Notation and Jama Connect Advisor™
    • 8 How to Write an Effective Product Requirements Document (PRD)
    • 9 Functional vs. Non-Functional Requirements
    • 10 What Are Nonfunctional Requirements and How Do They Impact Product Development?
    • 11 Characteristics of Effective Software Requirements and Software Requirements Specifications (SRS)
    • 12 8 Do’s and Don’ts for Writing Requirements
  • 3. Requirements Gathering and Management Processes
    • Overview
    • 1 Requirements Engineering
    • 2 Requirements Analysis
    • 3 A Guide to Requirements Elicitation for Product Teams
    • 4 Requirements Gathering Techniques for Agile Product Teams
    • 5 What is Requirements Gathering?
    • 6 Defining and Implementing a Requirements Baseline
    • 7 Managing Project Scope — Why It Matters and Best Practices
    • 8 How Long Do Requirements Take?
  • 4. Requirements Traceability
    • Overview
    • 1 What is Traceability?
    • 2 Tracing Your Way to Success: The Crucial Role of Traceability in Modern Product and Systems Development
    • 3 Change Impact Analysis (CIA): A Short Guide for Effective Implementation
    • 4 What is Requirements Traceability and Why Does It Matter for Product Teams?
    • 5 Key Traceability Challenges and Tips for Ensuring Accountability and Efficiency
    • 6 Unraveling the Digital Thread: Enhancing Connectivity and Efficiency
    • 7 The Role of a Data Thread in Product and Software Development
    • 8 How to Create and Use a Requirements Traceability Matrix
    • 9 Traceability Matrix 101: Why It’s Not the Ultimate Solution for Managing Requirements
    • 10 Live Traceability vs. After-the-Fact Traceability
    • 11 How to Overcome Organizational Barriers to Live Requirements Traceability
    • 12 Requirements Traceability, What Are You Missing?
    • 13 Four Best Practices for Requirements Traceability
    • 14 Requirements Traceability: Links in the Chain
    • 15 What Are the Benefits of End-to-End Traceability During Product Development?
  • 5. Requirements Management Tools and Software
    • Overview
    • 1 Selecting the Right Requirements Management Tools and Software
    • 2 Why Investing in Requirements Management Software Makes Business Sense During an Economic Downturn
    • 3 Why Word and Excel Alone is Not Enough for Product, Software, and Systems Development
    • 4 Application lifecycle management (ALM)
    • 5 Is There Life After DOORS®? 
    • 6 Checklist: Selecting a Requirements Management Tool
  • 6. Requirements Validation and Verification
    • Overview
    • 1 Requirements Verification and Validation for Product Teams
    • 2 Best Practices for Verification and Validation in Product Development
  • 7. Meeting Regulatory Compliance and Industry Standards
    • Overview
    • 1 Understanding ISO Standards
    • 2 Understanding ISO/IEC 27001: A Guide to Information Security Management
    • 3 What is DevSecOps? A Guide to Building Secure Software
    • 4 Compliance Management
    • 5 What is FMEA? Failure Modes and Effects Analysis
    • 6 TÜV SÜD: Ensuring Safety, Quality, and Sustainability Worldwide
  • 8. Systems Engineering
    • Overview
    • 1 What is Systems Engineering?
    • 2 The Systems Engineering Body of Knowledge (SEBoK)
    • 3 What is MBSE? Model-Based Systems Engineering Explained
    • 4 Digital Engineering Between Government and Contractors
    • 5 Digital Engineering Tools: The Key to Driving Innovation and Efficiency in Complex Systems
  • 9. Automotive Development
    • Overview
    • 1 Understanding IATF 16949: A Quick Guide to Automotive Quality Management
    • 2 ISO 26262 and Recent Updates: Ensuring Functional Safety in the Automotive Industry
    • 3 A Guide to Automotive Safety Integrity Levels (ASIL)
  • 10. Medical Device & Life Sciences Development
    • Overview
    • 1 The Importance of Benefit-Risk Analysis in Medical Device Development
    • 2 Software as a Medical Device: Revolutionizing Healthcare
    • 3 What’s a Design History File, and How Are DHFs Used by Product Teams?
    • 4 Navigating the Risks of Software of Unknown Pedigree (SOUP) in the Medical Device & Life Sciences Industry
    • 5 What is ISO 13485? Your Comprehensive Guide to Compliant Medical Device Manufacturing
    • 6 What You Need to Know: ANSI/AAMI SW96:2023 — Medical Device Security
    • 7 ISO 13485 vs ISO 9001: Understanding the Differences and Synergies
    • 8 Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know
    • 9 Embracing the Future of Healthcare: Exploring the Internet of Medical Things (IoMT)
  • 11. Aerospace & Defense Development
    • Overview
    • 1 ARP4754A / ED-79A: Enhancing Safety in Aviation Development
    • 2 Understanding ARP4761A: Guidelines for System Safety Assessment in Aerospace
  • 12. Architecture, Engineering, and Construction (AEC industry) Development
    • Overview
    • 1 What is the AEC Industry?
  • 13. Industrial Manufacturing & Machinery, Automation & Robotics, Consumer Electronics, and Energy
    • Overview
    • 1 Functional Safety Made Simple: A Guide to IEC 61508 for Manufacturing
    • 2 Understanding ISO 13849: The Foundation of Functional Safety in the Machinery Sector
    • 3 IEC 62061 – Functional Safety for Machinery Systems
    • 4 IEC 10218: Ensuring Safety in Industrial Robotics
  • 14. Semiconductor Development
    • Overview
    • 1 Why Chiplets Are Changing the Game in Tech Innovation
    • 2 Integrating Digital Engineering and the Digital Thread for Semiconductor Design
  • 15. AI in Product Development
    • Overview
    • 1 Artificial Intelligence in Requirements Management
  • Glossary

Understanding ISO 13849: The Foundation of Functional Safety in the Machinery Sector

Like many industries, functional safety is a critical part of machinery design – ensuring the protection of operators, equipment (and surrounding environments) from hazardous situations. To help maintain functional safety in industrial manufacturing, most organizations use ISO 13849, a globally recognized standard that provides comprehensive guidelines for achieving and validating functional safety in machinery control systems. In this subchapter, we’ll look at the importance of ISO 13849, key components, and how it shapes functional safety in the machinery sector.

According to an informal ISO/TC stakeholder survey, more than 89% of machine builders and more than 90% of component manufacturers and service providers use ISO 13849 as their functional safety standard.

RELATED ARTICLE: The Top Challenges in Industrial Manufacturing and Consumer Electronic Development

What is ISO 13849?

Officially titled “Safety of machinery – Safety-related parts of control systems”, ISO 13849 is an official standard that outlines the principles for designing and assessing the safety-related parts of control systems (SRP/CS). These are systems that directly influence the safety functions of a machine, e.g., emergency stops, interlocks, and protective barriers.

  • ISO 13849-1: Focuses on general principles for design and performance.
  • ISO 13849-2: Covers validation procedures for ensuring the compliance of safety functions.

By following ISO 13849, manufacturers can reduce the likelihood of machinery-related accidents and improve overall safety compliance.

Why is ISO 13849 Essential in the Machinery Industry?

Is it mandatory? Well, no.

However, the machinery sector operates in environments where equipment malfunctions can lead to severe injuries, fatalities, and property damage. Functional safety – as defined by ISO 13849 – helps mitigate these risks by emphasizing:

  • Reducing Risk: Identifying potential hazards and designing systems to minimize them.
  • Reliability: Ensuring that safety-related control systems perform their intended functions under all expected conditions.

It’s also important to note that compliance with ISO 13894 can also help teams avoid legal and financial repercussions if something does go wrong.

ISO 13849 bridges the gap between innovation and safety, enabling manufacturers to integrate cutting-edge technology without compromising operator protection.

RELATED ARTICLE: Jama Connect® for Robotics Datasheet

Key Info about ISO 13849

In this image, we show an engineer looking at a safety checklist and display the core principles of 13849.

ISO 13849 revolves around several core principles:

1: Performance Level (PL) – Performance Level quantifies the reliability of safety functions, categorized from PL a (lowest) to PL e (highest). Factors influencing PL include:

  • Hardware structure.
  • Diagnostic coverage (DC).
  • Mean time to dangerous failure (MTTFd).
  • Common cause failure (CCF) protection.

2. Risk Assessment and Reduction – Part of this standard is the emphasis on conducting thorough risk assessments to identify potential hazards and determine the necessary PL for mitigation.

3. Validation – Validation ensures that the implemented safety functions meet design specs and operate correctly under foreseeable conditions. ISO 13849-2 provides specific procedures for this step.

4. Diagnostics and Redundancy – Built-in diagnostics and redundant systems enhance reliability, preventing failures from leading to unsafe conditions.

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Implementing ISO 13849 in Functional Safety Design

Successfully implementing ISO 13849 needs a structured approach:

  • Risk Assessment: Analyze the machinery’s operational scenarios to identify risks.
  • Determine Safety Requirements: Define safety functions and their corresponding Performance Levels.
  • Design Safety Systems: Develop control systems with redundancy, diagnostic coverage, and robust design principles.
  • Validation: Test and validate by comparing to ISO 13849-2 to make sure you’re compliant.

RELATED ARTICLE: FORT Robotics Selects Jama Connect® to Replace Google Sheets for Product Development

Benefits of Choosing to Comply with ISO 13849

Adhering to ISO 13849 delivers a lot of advantages for machinery manufacturers and operators:

  • Enhanced Safety: Reduces the risk of accidents and improves operator confidence.
  • Regulatory Compliance: You’ll meet international safety standards, facilitating market entry and reducing liability.
  • Cost Efficiency: Minimizes downtime and damage from malfunctions.
  • Reputation Management: Demonstrates a commitment to safety and reliability, boosting brand credibility.

Challenges and Best Practices

Implementing ISO 13849 can be challenging, especially for manufacturers unfamiliar with its requirements. Some common obstacles could be:

  • Complexity in Risk Assessment: Accurately determining Performance Levels requires expertise.
  • Integration with Legacy Systems: Retrofitting older machines can be resource intensive.
  • Validation Procedures: Comprehensive testing can be time-consuming.
Some thoughts on overcoming these challenges:
  • Engage Experts: Don’t go it alone – collaborate with functional safety specialists.
  • Use Certified Components: Choose components that meet ISO 13849 requirements.
  • Invest in Training: Help your team succeed! Equip them with the knowledge to apply the standard effectively.

ISO 13849 serves as a cornerstone of functional safety in the machinery sector. By following its guidelines, manufacturers can design systems that not only meet regulatory standards but also provide robust protection against operational risks. In an industry where safety is paramount, ISO 13849 ensures that innovation and reliability go hand in hand.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Steven Meadow and McKenzie Jonsson.

In this Video, Learn About the Top Challenges in ICE

DEFINITION OF ISO 13849:

ISO 13849 is an official standard that outlines the principles for designing and assessing the safety-related parts of control systems (SRP/CS). These are systems that directly influence the safety functions of a machine, e.g., emergency stops, interlocks, and protective barriers.

PREVIOUS IEC 62061 – Functional Safety for Machinery Systems
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