Functional Safety

The dynamic development of automation and distributed intelligence, and in particular the new Industry 4.0 concepts, has led to an impressive increase in machinery, plants, devices and products in general, in which control systems that perform safety functions, such as electronic, programmable electronic, hydraulic or pneumatic.

It is becoming increasingly important for them to guarantee high quality, safety and security. The level of reliability of the safety device or function is generally identified by the acronym SIL - Safety Integrity Level.

The IEC / EN 61508 ed. 2010 series of standards and the IEC / EN 61511 series of standards set the standard for the design and management of safety instrumented systems (SIS) in plants, with particular attention to electrical, electronic and programmable electronic systems and more. They are used extensively in the chemical, petrochemical, refining, nuclear, railway transport, electromedical, industrial automation, automotive and embedded devices industries.

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This voluntary system is structured by steps and is designed to support manufacturers who, by designing hardware and software suitable for the safety functions for which they are created, must apply specific methodologies, planning safety from the design phase onwards, with the purpose of guaranteeing an adequate level of functional integrity.


On-site inspection of the device; device classification (examination of the elements); analysis of the specifications of the safety requirements to be fulfilled; verification of the technical documentation (component data sheets, electrical diagrams, etc.), verification of the documentation of the management system related to the design and manufacture of the devices.


Identification of the technical regulations applicable to the system; qualitative and quantitative analysis of the device elements (QFD - FMEA - FTA); analysis of reliability and availability of the device elements; drafting of the gap analysis regarding the defined security requirements and the regulatory requirements; sharing of its contents.


Checking and verification of any changes made to the device by the customer; verification of changes to the technical documentation.


Verification of the concept design; analysis of the safety functions; analysis of the safety requirements; hardware/software analysis; possible witness testing; evaluation of the SIL / PL achieved; software test (static analysis and module test); hardware/software integration test; execution of any type tests (mechanical and electrical).


To release the activity report and the attestation for the SIL / PL level that is reached for each safety function.

Industrial Automation and Machinery Directive

  • IEC/EN 62061 - Risk calculation with Safety Integrity Level
  • IEC/EN 61496 - Safety of machinery - Electro-sensitive protective equipment
  • IEC/EN 61800-5-2 - Adjustable speed electrical power drive systems - Part 5-2: Safety requirements - Functional

Automazione industriale e Direttiva Macchine

  • IEC/EN 62061 – Calcolo dei rischi con il Safety Integrity Level
  • IEC/EN 61496 – Sicurezza del macchinario – Apparecchi elettrosensibili di protezione
  • IEC/EN 61800-5-2 – Adjustable speed electrical power drive systems – Part 5-2: Safety requirements – Functional

Fire/explosion risk environments

  • IEC/EN 60079-29-3 – Explosive atmospheres – Part 29-3: Gas detectors – Guidance on functional safety of fixed gas detection systems
  • EN 50495 – Safety devices required for the safe functioning of equipment with respect to explosion risks
  • EN 50402 – Electrical apparatus for the detection and measurement of combustible or toxic gases or vapours or of oxygen. Requirements on the functional safety of gas detection systems / (Electrical apparatus for the detection and measurement of combustible or toxic gases or vapours, or oxygen)


  • EN 50126 (IEC 62278) – Railway applications – Specification and demonstration of reliability, availability, maintainability and safety (RAMS)
  • EN 50128 (IEC 62279) –  Telecommunications, signalling and processing - Software for control and protection systems
  • EN 50129 (IEC 62425) - Electronic safety systems for signalling


  • IEC/EN 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
  • IEC/EN 62304 – Medical device software

Consumer products

IEC 60730: Safety standards for household appliances


ISO 26262 – Road vehicles – Functional safety

Apparecchiature a gas e forni elettrici

  • EN 161 – Automatic shut-off valves for gas burners and gas appliances
  • EN 13611 - Safety and control devices for gas burners and gas burning appliances - General requirements
  • EN 298 - Automatic control systems for burners and gas or liquid fuel appliance systems
  • EN 50156 - Electrical equipment for furnaces and ancillary equipment. Require

Agricultural and forestry machinery

ISO 25119 – Tractors and machinery for agriculture and forestry

Safety system for lifts

ISO 22201 – Lifts (elevators), escalators and moving walks

Nuclear Sector

IEC 61513 – Nuclear power plants – Instrumentation and control important to safety – General requirements for systems

Embedded and consumer electronics products

  • IEC/EN 60335s – Safety of household and similar electrical appliances
  • IEC/EN 60730s – Automatic electrical controls

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