What’s new in Machine Safety After the publication of the second edition of IEC 62061 in 2021, the publication of the fourth edition of ISO 13849-1 has come in 2023. The update of ISO 13849 has been much awaited, since, in our experience, users of PL-ISO 13849 are much more numerous than users of SIL-IEC […]

What’s new in Machine Safety After the publication of the second edition of IEC 62061 in 2021, the publication of the fourth edition of ISO 13849-1 is coming in 2023. The update of ISO 13849 is much awaited, since, in our experience, users of PL-ISO 13849 are much more numerous than users of SIL-IEC 62061 […]

What is Configuration Management? Configuration is a set of elements that are part of the project that allow you to have full control of the product and know the essence of development. Configuration must at least show the following product information: Hardware Version Firmware version Possible variants or options Supplemental documentation, i.e. drawings, BOM, firmware […]

ISO 26262 key-points The ISO 26262 series of standards is an adaptation of the IEC 61508 series of standards needed to address the specific needs of the road vehicle sector. Some of its key-points are: Provides a reference for the automotive safety life cycle and supports the adaptation of activities to be performed during the […]

What is the ICSA Certificate The IIoT Component Security Assurance (ICSA) certification was inspired by recommendations published in the joint ISA Global Security Alliance (ISAGCA) and ISA Security Compliance Institute (ISCI) study. The ISASecure IIoT Component Security Assurance (ICSA) is a security certification program for IIoT devices and IIoT gateways. ICSA certification applies to IACS (Industrial Automation […]

Functional safety is a crucial factor when industrial products or equipment are used in situations which pose risks for either operators or the environment. The aim is to ensure that safety instrumented systems are functioning correctly, fully in line with their Safety Integrity Level (SIL).   Traditional risk analysis is no longer sufficient   However, […]

Difference between Prior Use, Proven in Use and Route 2H Here are the differences between the three types of field returns: Proven in Use (“PIU”) is a way to demonstrate a device’s ability to avoid systematic failures. This concerns IEC 61508 and so this mode of analysis is used by manufacturers Route 2H is used […]

What is Reliability Block Diagram (RDB) It is nothing more than a diagram that provides the relationship between component states and the success or failure of a given system function. So let us take a classic safety function consisting of sensor, logic solver and final elements:   Do you want to help our page grow? […]

What the Safety Analysis Report is for SAR stands for Safety Analysis Report, and is defined by NOG070, which is the guideline jointly developed by operators, suppliers and engineering companies, with financial support from the Norwegian Oil and Gas Association. The SAR is a document that analyzes the SIL capability of a set of devices […]

Definition of the Categories according to ISO 13849-1 The categories of ISO 13849-1 are conceptually the same as those of other standards relating to functional safety, such as IEC 615058. ISO 13849-1 also outlines the categories in a block diagram, where the safety function is divided into inputs (e.g. transmitters, switches, etc.), logic solvers (e.g. […]

How can one minimize the frequency of downtime? The answer to this question is not so straightforward, but IEC 61511 provides us with support in order to give an answer. First, it is necessary to define what a proof test is. Downtime is necessary to conduct tests so that latent failures within the process can […]

First of all, what differentiates IEC 61511 from IEC 61508? IEC 61511 and IEC 61508 are very closely connected: in fact, they talk about nearly the same life cycle and the same safety metrics. The main and most obvious difference between the two standards is that IEC 61511 is used primarily by integrators and bases […]

Why DIA is so important As well as the HARA analysis for identifying the ASIL Level, DIA is defined in the early stages of the lifecycle according to ISO 26262. A DIA is precisely the agreement between customer and supplier in which are specified the responsibilities for activities to be performed, evidence to be reviewed, […]

Content of the Safety Requirement Specification of an SRP/CS Safety requirement specifications must be drawn up and analyzed before starting design, since any other subsequent activity must be based on the requirements, starting with preparation of the SRP/CS. The safety requirement specifications of the SRP/CS should contain the following information at a minimum: Expected risk […]

Content of the IEC 62061 standard The international standard IEC 62061 specifies the requirements and provides recommendations for the design, integration and validation of safety-related control systems (SCSs) for machinery. It is applicable to control systems used individually or in combination to perform safety functions for machinery, including a group of machines working together in […]

1 – What are today’s most pressing issues regarding safety in the process industry? Digitalization in its various forms (e.g. the Internet of Things, Big Data and Artificial Intelligence) has undergone a massive expansion in recent years, influencing not just our everyday life, but also the whole industrial sector. Increasingly smart devices can work together […]

Definitions Here are explained all the definitions that the standard IEC 61508 Parts 1-7 presents.   Functional Safety: Part of the overall safety relating to the EUC and the EUC control system that depends on the correct functioning of the E/E/PE safety-related systems and other risk reduction measures.   Safe State: State of the EUC […]

Standard definitions Machine control system: System which responds to input signals from parts of machine items, operators, external control equipment or any combination of these and generates output signals causing the machine to behave in the intended manner.   Safety-related part of a control system (SRP/CS): Part of a control system that responds to safety-related […]

What is the Risk Graph method? Annex A (information) of EN ISO 13849-1 illustrates a method, based on the Risk Graph, for defining the PLr based on the severity of the risk to be mitigated. The precise risk to be mitigated is point 1 of the graph.   Do you want to help our page […]

ASIL Level vs. HARA method The ASIL Level is calculated with the HARA method, which aims at identifying and categorizing hazardous events of items, and also at specifying safety goals according to ISO 26262. HARA (Hazard and Risk Assessment Analysis) is assessed in the early stages of the Safety Lifecycle, so it takes place after […]

1. Is it compulsory to be certified also ISO 9001 in order to obtain the SIL certificate? No, IEC 61508 does not require ISO 9001 certification, but this is nevertheless preferable, as it facilitates process review and shortens the timeframe for audits and the issuing of the SIL certificate.   2. What is the duration of the SIL certificate? The […]

Functional Safety Certification A device can be subjected to a third-party assessment, to certify its SIL and so show that it meets the requisite functional safety standards, thus ensuring its compliance with the requirements of standard IEC 61508. SIL certification is globally valid and is the most direct and authoritative way to demonstrate the complete […]

In this guide you will learn: Functional safety: main concept Structure of IEC 61508 standard What is SIL (Safety Integrity Level) Functional safety elements Functional safety lifecycle Types of applicable requirements PFDavg/PFH SIL level Functional Safety Management System     Learn the basics of Functional Safety through this short guide. We recommended you are aware […]

Why obtain the ISASecure® Certification The benefits of ISASecure® certification are many. In particular, it: Establishes a higher level of trust Improves product security Establishes company policy for the use of ISA/IEC 62443 Updates product development processes to comply with IEC 62443 Proves a proactive approach to achieve competence in cyber security Improves product sales […]

ISO 26262 Standard Application It covers the implementation of functional safety through electrical and/or electronic (E/E) systems, and presents a specific lifecycle for items used in the automotive sector. Thus, it provides a reference for the automotive safety life cycle and supports the adaptation of activities to be performed during the lifecycle phases, i.e. development, […]

ISASecure® certification scheme ISASecure® is a third-party conformity assessment scheme based on the ISA/IEC 62443 series of standards aimed at cybersecurity certification of IACS systems, such as DCS and SCADA. A third-party conformity assessment scheme is also known as a certification scheme. The goal of the ISA/IEC62443 Series is to improve Industrial Automation and Control […]

IEC 62443 family of standards The most relevant parts of IEC 62443, for the development of secure products throughout the entire lifecycle, and in order to obtain the ISASecure® Certification as well, are: Part 1-1: Terminology, concepts, and models introduce the concepts and models used throughout the series. The intended audience includes anyone wishing to […]

ISO 13849 for Performance Level verification and validation The ISO 13849 standard is composed of two sections: The first part of the standard, ISO 13849-1, is well-known in the safety field. It concerns the design of the SRP / Cs, and provides the manufacturer with the requirements necessary to be able to design and build […]

SIL calculation methods SIL verification through calculation can follow: Markov approach. Markov’s analysis covers most aspects of quantitative safety assessment and provides great flexibility. The approach is based on calculating the probability that the system is in a specific state at a specific time. Petri Net. The Montecarlo simulation consists in animating behavioral models using […]

Software System and Applicative Software Software system is part of the software of a programmable electronic system that relates to the operation and services provided by the programmable device itself, such as a PLC Embedded Software. The applicative software is rather part of the software of a programmable electronic system that specifies the functions that […]

Difference between Reliability and Availability Reliability is defined as the probability that a device’s performance will remain unchanged over time, after determining the conditions of use. The fundamental parameter for determining the reliability of an object is its failure rate, i.e. the number of failures it undergoes in the set time of one hour. Reliability forecasting techniques […]

What the IEC 62443 standard aims at The IEC 62443 is the international standard for the security of industrial automation control systems. This standard is therefore the only reliable solution for Cyber Security in the field of industrial automation. This standard was set up almost twenty years ago by a group of volunteers belonging to […]

Meaning of SIF A SIF (Safety Instrumented Function) is a safety function with a specific safety level, necessary to reach or maintain a safe state. A SIF can be: Protection function, safety function able to maintain a safe state when a dangerous event occurs Mitigation function, safety function able to reach a safe state after […]

Hardware Failure A fault occurs when a predetermined function cannot be performed or performance is outside the requirements. Regarding hardware failures, mostly they are random failures: Safe failures Dangerous failures No effect failures No part failures   Download Infographics Do you want to contribute to our page? Follow us on Linkedin   Safe failures Failure […]

Hazard and risk analysis phase The aim of risk analysis is to identify what the hazards are, how often they might happen, and when they are tolerable, specifically for a system, process or component. The recommended method is ALARP (As Low As Reasonably Practicable), where risk must be lowered as much as reasonably practicable. This […]

The 16 Functional Safety Lifecycle Phases The standard introduces the concept of a Safety Lifecycle to ensure that all activities, actions, and tests are implemented so as to guarantee the required level of safety. IEC 61508 indicates 16 phases, specifying for each: Objectives to achieve Requirements to meet Purpose of each phase Inputs and outputs […]

What is the SIL Certificate? The SIL certificate is a functional safety certificate that demonstrates the conformity of a product or process with the IEC 61508 international standards. The certificate is issued by a third party to ensure compliance with the requirements for independence imposed by IEC 61508-1 in order to reach the highest SIL 3 and 4 levels, […]

What is Functional Safety? In complex modern industrial facilities, great importance must be attached to safety aspects, whether they relate to people, the environment or the infrastructure itself. The risks associated with the operation of any system must be mitigated to achieve an acceptable level of safety. If this is not possible with the control […]

Basic principles of EN ISO 13849 The main purpose of ISO 13849-1, General principles for design, and ISO 13849-2, Validation, is to regulate the level of performance that the safety-related parts of control systems of a machine must have in order to be considered a suitable mitigation measure of a specific risk. The ISO 13849-1/2 […]

 Difference between IEC 61508 e IEC 61511 standards IEC 61511 is used by integrators in processes and systems. It applies to safety devices integrated in a safety system, which comply with IEC 61508. The requirements remain the same for both IEC 61508 and IEC 61511 (quantitative, qualitative and semi-quantitative).   IEC 61508 recommends the requirements […]

What FMEDA aims at FMEDA consists of two separate analyses, Failure Mode and Effects Analysis (FMEA) and Diagnostic Analysis (DA). This analysis is used to determine the diagnostic coverage and safety fault fraction (SFF) and must include all components, including electrical, electronic, electromechanical, mechanical, etc., necessary to enable the element to process the safety function(s) […]

What the FSMS aims at The first objective of the requirements in IEC 61508-1 clause 6.1.1 is to specify the responsibilities in the functional safety management of those in charge of an E/E/PE safety system or one or more phases of the overall lifecycle of an E/E/PE system and the safety software.   The second […]

What is a Safety Manual? The safety manual is a document required for any system or product certified according to IEC 61508:2 and IEC 61508:3 where it is indicated as a mandated document to be made available by the manufacturer together with any SIL device. The purpose of the safety manual is to provide all the information […]

Some examples of standards by sector The most important Functional Safety standards by sector are: ISO 13849 Machine Safety EN 50126/8/9 Railway IEC 61800-5-2 Electrical Drivers IEC 61513 Nuclear Sector EN 60601 Medical Devices IEC 50156 Furnaces IEC 61511 Process Industry IEC 62061 Machinery ISO 26262 Automotive IEC 61131-6 PLC   In particular, regarding machinery, […]

What the FSA aims at Functional Safety Assessment consists of three phases: Detailed review of hardware and software design, where auditors review the product design against functional safety requirements together with the manufacturer’s designers; Revision of the development of the Functional Safety Management System, which aims to verify the presence and applicability of a management […]

What IEC 61508 aims at IEC 61508 provides safety equipment suppliers and users with a common framework to design products and systems for safety-related applications. It consists of 7 parts: IEC 61508-1 Generic Requirements: defines the activities, documentation, management and validation related to each phase of the safety lifecycle; IEC 61508-2 Requirements for E/E/PE systems: […]