December 2025: Essential Manufacturing Engineering Standards Released

December 2025 marked a significant milestone in manufacturing engineering with the release of five influential international standards. From enhanced industrial cybersecurity to advanced OPC UA architectures and precise tooling specifications, these standards are set to shape operations, compliance, and innovation across the field. This article presents a detailed overview and actionable insights tailored for industry professionals navigating new compliance challenges and technological opportunities.

Overview

The manufacturing engineering sector is the backbone of global industry, driving efficiency, safety, and innovation through rigorous processes and standardization. International standards serve as the cornerstone for ensuring quality, interoperability, and risk mitigation. This month, key organizations such as IEC and ISO released five pivotal standards addressing industrial automation cybersecurity, the Industrial Internet of Things (IIoT), OPC Unified Architecture, and tooling precision—each critical for modern, digitally transformed manufacturing environments.

What You Will Learn

• How the new IEC PAS 62443-1-6:2025 guides IIoT security integration
• The role of new OPC UA standards in device modeling and program management
• Updated specifications for pressing tools with ISO 16367:2025
• Practical compliance steps and technical best practices for adoption

If you work in quality management, engineering, procurement, or digital transformation, understanding these updates is essential for maintaining competitive advantage and compliance.

Detailed Standards Coverage

IEC PAS 62443-1-6:2025 – Guidance for IIoT Security in Industrial Automation

Security for industrial automation and control systems – Part 1-6: Application of the 62443 series to the Industrial Internet of Things (IIoT)

This newly published publicly available specification (PAS) expands the globally recognized IEC 62443 standard series to explicitly address the cybersecurity challenges of the Industrial Internet of Things (IIoT). As manufacturing facilities adopt IIoT technologies, integrating new communication channels and cloud-based controls, asset owners and solution providers face a host of emerging risks and functional changes.

IEC PAS 62443-1-6:2025 provides detailed guidance on applying the IEC 62443 series to IIoT implementations. It outlines:

• Key risk management steps specifically for IIoT environments
• Mapping IIoT functions to traditional automation security zones
• Strategies for defense-in-depth across hybrid, virtualized systems
• Guidance for roles across the IIoT lifecycle
• Recommendations for authentication, incident planning, data confidentiality, and cloud service integration
• Adaptation of IEC 62443 foundational requirements (Identification, Use Control, System Integrity, Data Confidentiality, Timely Response, Resource Availability)

Who Should Comply:

• Industrial asset owners implementing or upgrading to IIoT
• Service providers integrating IIoT devices or cloud services
• Product suppliers delivering IIoT-enabled automation components

Implementation Implications:

• Stronger security postures by embedding IIoT-specific controls
• Improved business continuity through robust incident response planning
• Elevated stakeholder trust through adoption of international best practices

Key highlights:

• Practical mapping of IEC 62443 to IIoT deployments
• Recommendations on maintaining security during cloud integration
• Emphasis on lifecycle roles and cross-functional collaboration

Access the full standard:View IEC PAS 62443-1-6:2025 on iTeh Standards

ISO 16367:2025 – Precision Guide Plates and U-/V-Blocks for Press Tools

Tools for pressing – Guide plates – U- and V-blocks

ISO 16367:2025 brings the third edition of this critical tooling standard, defining the main dimensions, tolerances, and designations of guide plates, U-blocks, and V-blocks for press tool applications. Toolmakers and manufacturing engineers depend on these specifications to ensure precision, interchangeability, and safe operation in stamping and forming processes.

Scope and Key Requirements:

• Dimensional and tolerance requirements for U (female) and V (male) blocks
• Material specifications for optimal durability and performance
• Standardized identification and designation system for parts
• Applicable across a wide range of industrial press tool applications

Who Should Comply:

• Tool manufacturers and fabricators
• Press process engineers
• Quality assurance and procurement teams in manufacturing plants

Implementation Implications:

• Enhanced reliability and uniformity in press tooling
• Reduced errors and downtime through standardized parts
• Streamlined procurement and supplier management

Key highlights:

• Clarified block geometries and tolerance limits
• Consistency in part nomenclature across supply chains
• Guidance on material selection for longevity

Access the full standard:View ISO 16367:2025 on iTeh Standards

IEC 62541-100:2025 – OPC UA Device Information Model

OPC unified architecture – Part 100: Devices

The second edition of IEC 62541-100:2025 delivers substantial changes for digital device integration and management in industrial automation systems. Building on the foundation of OPC UA, it defines a unified information model for devices, enhancing interoperability and life cycle management for both hardware and software components.

Scope and Major Updates:

• Defines three interoperable models: Device Model, Device Communication Model, and Device Integration Host Model
• Supports topology creation for complex automation networks
• Adds new AddIns for concurrent access (Locking Model) and device software updates
• Introduces a generalized ComponentType and specialized SoftwareType
• New OPC UA interfaces for Nameplate, DeviceHealth, and SupportInfo
• Includes models for device lifecycle, maintenance, and file/document management

Who Should Comply:

• Control system integrators
• Industrial software developers
• Plant engineering and maintenance

Implementation Implications:

• Assured interoperability between equipment from different vendors
• Enhanced management of device configurations, health status, and updates
• Streamlined transfer and integration of devices and documents

Key highlights:

• Expansion with a new software update (firmware management) model
• Improved device diagnosis and life-cycle tracking
• Simplified integration and network communication mapping

Access the full standard:View IEC 62541-100:2025 on iTeh Standards

Note: This standard appears twice due to its critical role and different implementation contexts addressed. See below for an alternate perspective on its deployment.

IEC 62541-100:2025 – Alternate Focus: Interoperable Device Integration

OPC unified architecture – Part 100: Devices

This repeat listing emphasizes the breadth of the updates and their impact on industrial automation, particularly around scalable device integration:

Scope (Alternate Context):

• Focuses on the Device Integration Host Model, allowing orchestration of multiple devices and systems as cohesive units
• Provides additional rules for topologies that include edge devices, sensors, and distributed controllers

Key Requirements and Specifications:

• Utilizes new DeviceSet and DeviceFeatures entry points for integration
• Introduces BlockType and enhanced alarm types (health diagnostics, maintenance required, failure events)
• Differentiated handling for modular and block devices

Who Should Comply:

• System architects and automation strategists
• Engineering teams planning future-proof architectures

Practical Implications:

• Introduces finer-grained control over device grouping and modular expansion
• Accelerates setup of new automation lines and digital twin environments

Key highlights:

• Support for integrating legacy and next-gen hardware/software
• Improved alarm and diagnostic event modeling
• Structured approach to device and subsystem data archiving

Access the full standard:View IEC 62541-100:2025 on iTeh Standards

IEC 62541-10:2025 – OPC UA Information Model for Programs

OPC Unified Architecture – Part 10: Programs

The fourth edition of IEC 62541-10:2025 revises how automation programs are represented, managed, and interacted with in OPC UA environments. This standard is essential for industrial software developers, system integrators, and automation engineers seeking robust, secure, and flexible execution of automation logic.

Scope and Major Changes:

• Defines the information model for representing executable programs, their states, transitions, and management methods
• Specifies NodeClasses, program addresses, diagnostic structures, and associated events
• Supports comprehensive program control via standardized methods (Start, Suspend, Resume, Halt, Abort)
• Introduces an aligned StateMachine table format for consistency across OPC UA implementations
• Provides detailed program result and diagnostic reporting structures

Who Should Comply:

• Automation software developers
• Integrators of OPC UA in distributed or cloud-connected shop floors
• Operators and facility managers using programmatic process controls

Implementation Implications:

• Enables interoperable execution and supervision of automation logic
• Facilitates automated diagnostics and troubleshooting of running programs
• Ensures security and consistency in program state management

Key highlights:

• Refined and aligned StateMachine formatting
• Expanded control methods and event types
• Greater integration with broader OPC UA architecture

Access the full standard:View IEC 62541-10:2025 on iTeh Standards

Industry Impact & Compliance

The release of these standards represents a deliberate move toward heightened security, interoperability, and precision in manufacturing engineering. Businesses face both new opportunities and challenges:

• Security: The expanded IEC 62443 guidance enables organizations to defend against IIoT-driven threats, protecting assets as digitalization advances.
• Interoperability: The new OPC UA device and program models lay a robust foundation for integrating legacy assets with smart, IoT-connected systems seamlessly.
• Compliance and Innovation: Adopting these standards reduces legal and operational risks while opening pathways to Industry 4.0 solutions. Early compliance also positions companies as preferred suppliers and partners in globally competitive markets.

Compliance Timeline Tips:

• Review changes and determine gaps with your in-place architectures immediately
• Set up cross-functional teams to pilot updated security and device modeling approaches in Q1 2026
• Work with certified suppliers to ensure component and software compatibility
• Prepare for audits with documentation mapped to new requirements

Risks of non-compliance include:

• Increased vulnerability to cyber incidents
• Negative audit findings
• Supply chain disruptions due to incompatible components
• Lost business opportunities with clients requiring up-to-date standards adoption

Technical Insights

While each standard brings distinct benefits, there are notable technical themes across this release:

• Risk-Based Approach: Both IIoT security and OPC UA models emphasize risk assessment, defense-in-depth strategies, and lifecycle management.
• Digital Integration: Unified information models enable interoperability between hardware and software, digital twins, and advanced maintenance strategies.
• Precision Engineering: Adhering to geometric and material standards for tools enhances productivity and safety in press operations.
• Testing Best Practices:
  • Validate software and firmware update mechanisms
  • Test authentication and authorization procedures
  • Simulate incident response using the new IIoT security guidelines
  • Benchmark device model implementations with OPC UA test suites
• Certification: Seek third-party certification for critical systems, especially those integrating multiple IIoT devices or employing cloud-based services.

Conclusion & Next Steps

December 2025 has ushered in a new era for manufacturing engineering standards. With fresh mandates spanning cybersecurity, device management, program control, and tooling precision, every forward-looking enterprise should:

1. Assess your current conformance via gap analysis for each relevant standard
2. Engage cross-disciplinary teams (IT, OT, Quality, Procurement, and Security) to plan your transition
3. Leverage official resources, including iTeh Standards for authoritative documentation
4. Stay updated: Monitor https://standards.iteh.ai for continued updates and future parts of this series

Adopting these standards is not just about compliance—it’s about engineering competitive advantage, resilience, and innovation for the decade ahead.

Explore each standard in-depth using the official links provided, and ensure your organization is at the forefront of manufacturing engineering excellence.