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Functional Safety

What is DIA (Development Interface Agreement) for ISO 26262?

Why DIA is so important As well as the HARA analysis, 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, or work products to be […]

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3 Questions about the Future of Functional Safety

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 […]

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Functional Safety Glossary

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 […]

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What does HARA mean for ISO 26262?

The HARA method The HARA method aims at identifying and categorizing hazardous events of items, and also at specifying safety goals according to ISO 26262 and ASILs (Automotive Safety Integrity Levels) related to the prevention or mitigation of the associated hazards in order to avoid unreasonable risk. This means that the combination of a hazard […]

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FAQ about Functional Safety

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 […]

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Functional Safety and Cyber Security: what’s the link between them?

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 […]

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Download the Functional Safety Guide

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     Recommended in-depth study: FAQ about Functional Safety  

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A brief introduction to ISO 26262

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, […]

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SIL Level calculation

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 […]

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Software Safety Management

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 […]

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RAMS Engineering

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 […]

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SIL Level and Safety Function meaning

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 […]

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Types of Failure and Architecture examples

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 […]

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Risk Reduction Strategies

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 […]

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Functional Safety Lifecycle

Fasi del Functional Safety Lifecycle 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   […]

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SIL Certification Overview

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, […]

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What is Functional Safety (IEC 61508)?

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 […]

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IEC 61508 vs. IEC 61511 Requirements

 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 […]

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What is FMEDA method

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) […]

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Functional Safety Management System

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 […]

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Safety Manual

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 […]

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Functional Safety standards by sector

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, […]

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Functional Safety Assessment phases

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 […]

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Structure of IEC 61508

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: […]

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