September 2026: New Functional Safety Standard for Manufacturing Engineering

In September 2026, the manufacturing engineering sector received a pivotal update with the publication of prEN IEC 61508-1:2025. As manufacturing processes become increasingly automated and digitally integrated, setting rigorous benchmarks for functional safety in electrical, electronic, and programmable electronic safety-related systems is more critical than ever. This standard’s release underscores the industry’s commitment to enhanced risk management, system reliability, and regulatory compliance across a broad range of applications. Covering general requirements applicable to diverse sectors, this update is essential reading for professionals overseeing the design, commissioning, operation, and maintenance of safety-related systems.

Overview / Introduction

Manufacturing engineering continually evolves with rapid advancements in automation, digitalization, and systems integration. Within this dynamic environment, the safety and stability of complex electrical and electronic control systems directly impact operational integrity, worker safety, and regulatory compliance. International standards like prEN IEC 61508-1:2025 provide a unified, robust framework for managing functional safety throughout the entire lifecycle of safety-related systems. This article offers a deep dive into the latest standard, its scope, benefits, and what industry stakeholders need to know for successful implementation and compliance.

Why Standards Matter in Manufacturing Engineering

Functional safety standards are foundational in minimizing risks posed by failures in automated systems and protecting both people and assets. They provide:

• Structured approaches for hazard and risk management
• Proven processes for documentation, validation, and verification
• Clear guidelines for competency, independence, and quality management
• A risk-based method for specifying safety integrity requirements (SIL)

This ensures that safety functions in manufacturing equipment perform reliably, even under fault conditions or adverse environments, maintaining not only compliance but also the trust of operators, regulators, and clients.

Detailed Standards Coverage

prEN IEC 61508-1:2025 – Functional Safety of Electrical/Electronic/Programmable Electronic Safety-Related Systems – Part 1: General Requirements

CLC – Published 2026-09-08

What the Standard Covers & Scope

prEN IEC 61508-1:2025 establishes the general requirements for functional safety across the entire lifecycle of electrical, electronic, or programmable electronic (E/E/PE) safety-related systems. The standard is generic and applies to all industry sectors, including but not limited to industrial process measurement, control, and IT applications in industry. Its purpose is to provide a comprehensive framework for identifying risk, defining safety lifecycle phases, and supporting the development, implementation, and maintenance of safety-critical systems.

Key Requirements and Specifications

• Safety Lifecycle Management: Outlines the overall safety lifecycle, from concept through decommissioning, ensuring that all phases are addressed—hazard identification, risk analysis, system specification, design, validation, operation, modification, and disposal.
• Hazard and Risk Analysis: Mandates robust processes for identifying foreseeable hazards, considering human factors, reasonably foreseeable misuse, and cybersecurity risks.
• Safety Integrity Levels (SIL): Imparts a risk-based approach to determine the required SIL for safety functions, clarifying the differentiation between required SIL and achieved Systematic Capability (SC).
• Documentation, Assessment, and Audit: Requires rigorous documentation for each safety lifecycle phase, continuous performance monitoring, and independent audit and assessment processes.
• Competency and Management: Specifies requirements for management responsibility, competency assessment, and documented procedures for every stakeholder involved in the lifecycle.

Who Needs to Comply?

This standard is targeted at organizations responsible for the design, implementation, and operation of safety-related control, protection, and mitigation systems in manufacturing environments, including:

• Manufacturers of safety-related equipment (hardware, software)
• System integrators
• Plant operators
• Engineering design and consulting firms
• Certification and testing bodies

Practical Implications for Implementation

Enterprises must ensure end-to-end application of the safety lifecycle, document every phase, regularly review and update safety plans, and train personnel to the required competencies. Compliance means proactively managing both systematic and random hardware/software failures, implementing requirements management systems, and establishing verification, validation, and audit routines. Special attention is necessary for integration with cybersecurity assessments (referencing IEC 62443, ISO/IEC 27000 series) and accommodating AI-based components (with references to ISO/IEC TS 22440 and ISO/IEC 22989 for AI technology classes).

Notable Changes from Previous Editions

The 2025 edition introduces several substantive updates:

• Upgrades the document structure per the 2024 ISO/IEC Directives, enhancing clarity and alignment with international editorial standards
• Expands scope to clarify requirements related to artificial intelligence, cybersecurity, and human factors, especially in hazard and risk analysis
• Removes duplication across IEC 61508 series parts and strengthens interface requirements
• Introduces new requirements for independence in safety assurance activities (Annex B)
• Provides improved guidance for documentation, version control, and change management

Key highlights:

• Comprehensive, risk-based safety lifecycle approach
• Enhanced clarification of safety integrity levels and systematic capability metrics
• Explicit consideration for AI, cybersecurity, and human factors

Access the full standard:View prEN IEC 61508-1:2025 on iTeh Standards

Industry Impact & Compliance

Effects on Businesses and Manufacturing Operations

Adoption of prEN IEC 61508-1:2025 prompts organizations to revisit their safety management systems, technical risk assessments, and operational practices. The new requirements enhance accountability, documentation, and audit readiness, making compliance both a technical and organizational imperative.

Compliance Considerations and Timelines

• Gap Analysis and Transition Plans: Organizations must perform gap analyses against the new standard, updating procedures and systems accordingly. Transition timelines will depend on risk, system complexity, and existing compliance maturity.
• Personnel Training: All roles—from management to engineering—require upskilling in lifecycle and documentation best practices, hazard analysis, and functional safety concepts.
• Documentation Readiness: Rigorous version control, traceability, and document structure must be employed to support audits, assessments, and regulatory reviews.

Benefits of Adoption

• Increased operational safety and asset protection
• Greater confidence in the reliability of safety-related systems
• Streamlined compliance with regulators and clients
• Structured approach to introducing and managing new technologies (e.g., AI, IoT, cybersecurity)

Risks of Non-Compliance

• Significant risk of operational incidents, regulatory penalties, or liability
• Reduced competitiveness in sectors where safety and reliability are non-negotiable client requirements
• Difficulty obtaining third-party certifications or market access for safety-rated equipment

Technical Insights

Common Technical Requirements

• Risk-Based Hazard Analysis: Systems must integrate processes for identifying all possible hazardous events, considering not only technical faults but also human and cybersecurity factors.
• Lifecycle Documentation: Meticulous records are required for each phase, ensuring that all activities and decisions are traceable and auditable.
• Safety Integrity Level (SIL) Assignments: E/E/PE safety functions must be assessed for required SIL based on risk assessments, with proper allocation and validation ensuring critical system behaviors are achieved.
• Verification and Validation: Each system phase must have appropriate tests, checks, and independent reviews to confirm implementation meets requirements.

Implementation Best Practices

1. Establish Multidisciplinary Teams: Combine expertise from engineering, IT security, operations, and quality assurance to cover all aspects of the functional safety lifecycle.
2. Use Requirements Management Software: Implement systems that streamline requirements traceability, configuration control, and change management.
3. Incorporate Security Assessments: Coordinate with cybersecurity teams to address threats identified in the hazard and risk analysis phase, referencing standards like IEC 62443.
4. Plan for Periodic Functional Audits: Institute scheduled audits per the standard’s requirements, leveraging independent assessors to validate compliance and independence.
5. Continuous Training and Competence Management: Regularly assess and update staff competencies, especially given new requirements for AI, ergonomics, and cross-discipline communications.

Testing and Certification Considerations

• Engage Accredited Bodies Early: Start dialogue with certification agencies to clarify interpretation, documentation, and test requirements early in system development.
• Plan for SIL Verification: Use safety lifecycle phases (as outlined in Table 1 of the standard) to align test plans and documentation for each function and hardware/software element.
• Automated Test Records: Utilize digital tools for recording, validating, and maintaining version histories of tests and assessments.

Conclusion / Next Steps

The publication of prEN IEC 61508-1:2025 sets a fresh benchmark for functional safety in manufacturing engineering, enabling organizations to address evolving technological, human, and regulatory challenges through proven, lifecycle-based methodologies. To stay competitive and resilient:

• Initiate gap assessments against the new requirements
• Update lifecycle management documentation and procedures
• Prioritize personnel training and independent audit structures
• Leverage digital tools for documentation and requirements management
• Monitor developments in sector-specific applications and harmonized standards

Stay engaged with ongoing updates and best-practice guidance by exploring the full standard at iTeh Standards, and ensure your organization remains at the forefront of safety and compliance.

Access the full standard:View prEN IEC 61508-1:2025 on iTeh Standards