Which functional safety standards should I follow?

How to choose functional safety standards for a product?  

To ensure that a product is free from unreasonable safety-related risks, it is recommended to develop it in compliance with state-of-the-art safety standards. However, with numerous standards available, adhering to all of them is neither practical nor necessary. Instead, it is important to identify and adopt the most relevant standards based on the product’s intended application. 

The applicable functional safety standards are determined by several factors: 

• The industry(domain) in which the product will be used 

• The type of technology that it incorporates 

• Applicable regulatory and stakeholder requirements 

Functional Safety standards across different industries (domains) 

The most fundamental functional safety standard across all industries is IEC 61508. It provides a framework for the design, implementation, testing, and maintenance of safety-critical systems. This standard serves as the foundation for developing industry-specific functional safety standards. Some of the most common functional safety standards are listed below.

Figure 1: Visual representation of the standards

Industry	Standards	Description
All safety critical industries	IEC 61508	Functional safety of electrical/electronic/programmable electronic safety-related systems
Automotive (e.g. cars, trucks, motorcycles)	ISO 26262	Road vehicles - Functional safety
Agriculture and Forestry (e.g. tractors)	ISO 25119	Tractors and machinery for agriculture and forestry - Safety-related parts of control systems
Earth Moving machinery (e.g. tractors, excavators, loaders, graders, etc.)	ISO 19014	Earth-moving machinery - Functional safety
Machinery (E.g. Industrial machinery, robotic arms, Cobots)	ISO 13849	Safety of machinery
Machinery (E.g. Industrial machinery, robotic arms, Cobots)	IEC 62061	Safety of machinery - Functional safety of safety-related control systems
Machinery (E.g. Industrial machinery, robotic arms, Cobots)	ISO 12100	Safety of machinery - General principles for design - Risk assessment and risk reduction
Machinery (E.g. Industrial machinery, robotic arms, Cobots)	ISO 13857	Safety of machinery - Safety distances to prevent hazard zones being reached by upper and lower limbs
Military systems (E.g. - Weapons systems, combat vehicles (tanks, armored trucks), Ground support equipment (Radar)	MIL-STD-882E	Department of Defense – System Safety
Aerospace: Airborne (E.g. Commercial aircraft, Helicopter, UAVs, EVTOLs)	DO-178C	Software Considerations in Airborne Systems and Equipment Certification
Aerospace: Airborne (E.g. Commercial aircraft, Helicopter, UAVs, EVTOLs)	DO-254	Design Assurance Guidance for Airborne Electronic Hardware
Aerospace: Airborne (E.g. Commercial aircraft, Helicopter, UAVs, EVTOLs)	EUROCAE ED-12B	Software considerations in airborne systems and equipment certification
Aerospace: Ground equipment	DO-278A	Software Integrity Assurance Considerations for Communication, Navigation, Surveillance and Air Traffic Management (CNS/ATM) Systems
Nuclear Power Plants	IEC 61513	Nuclear power plants - Instrumentation and control important to safety
Railway applications	EN 50126	Specification and Demonstration of Reliability, Availability, Maintainability and Safety (RAMS) Generic RAMS Process
Railway applications	EN 50128	Communication, signaling and processing systems - Software for railway control and protection systems
Railway applications	EN 50129	Communication, signaling and processing systems - Safety related electronic systems for signaling
Robotics applications (E.g. Industrial robots)	ISO 10218	Robotics - Safety requirements
Collaborative Robots	ISO/ TS 15066	Robots and robotic devices - Collaborative robots Note: This supplements the requirements and guidance on collaborative industrial robot operation given in ISO 10218
Personal Care Robots	ISO 13482	Robots and robotic devices - Safety requirements for personal care robots
Medical Equipment (e.g. respiratory gas monitors, dental equipment, EEG, etc.)	ISO 80601	Medical electrical equipment – Particular requirements for the basic safety Note: ISO 80601 contains several standards, each of them focusing on a medical application
Medical Equipment (e.g. respiratory gas monitors, dental equipment, EEG, etc.)	IEC 62304	Medical device software - Software life cycle processes
Medical Equipment (e.g. respiratory gas monitors, dental equipment, EEG, etc.)	IEC 60601	Medical Electrical Equipment - General requirements for basic safety and essential performance

Safety standards for technology-specific applications

In addition to industry-specific functional safety standards, it is highly recommended to incorporate technology-specific standards to ensure comprehensive safety coverage. Some commonly referenced safety standards include:

Industry	Standard	Description
Automotive (e.g. cars, trucks, motorcycles)	ISO 21448	Road vehicles - Safety of the intended functionality
Automotive (e.g. cars, trucks, motorcycles)	ISO 8800	Road vehicles - Safety and artificial intelligence
Automotive (e.g. cars, trucks, motorcycles)	UL 4600	Standard for Safety for the Evaluation of Autonomous Products
Automotive (e.g. cars, trucks, motorcycles)	IEEE 7001	IEEE Standard for Transparency of Autonomous Systems
Robotics applications (E.g. Industrial robots)	ANSI/RIA R15.06	Industrial Robots and Robot Systems - Safety Requirements
Robotics applications (E.g. Industrial robots)	ANSI/RIA R15.08	Industrial Mobile Robots - Safety Requirements
Robotics applications (E.g. Industrial robots)	UL 3300	Standard for Safety - Service, Communication, Information, Education and Entertainment Robots
Fuel cell vehicles	ISO 23273	Fuel cell road vehicles - Safety specifications - Protection against hydrogen hazards for vehicles fueled with compressed hydrogen
Electric Vehicles	ISO 6469	Electrically propelled road vehicles - Safety specifications

Bridging compliance between safety standards across different industries

There is a degree of equivalence between functional safety standards. Meeting the requirements of one standard often supports compliance with others. This is because many standards share common principles, such as risk assessment, systematic development, and safety lifecycle management. The table below shows the equivalence between different standards.

Figure 2: Bridging compliance between safety standards (Source)

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