Is your product truly safe for its entire lifespan? While reliability engineering teaches us about "Useful Life"—the period before device failure rates rapidly increase—this crucial concept has often been overlooked in functional safety for electronics. In fact, failure rate predictions are only valid during the Useful Life.
When the FMEDA method was developed in the late 1980s, the prevailing belief was that electronic components, lacking moving parts, would last for decades. Consequently, the "Useful Life" metric wasn't initially a standard part of functional safety analysis.
However, decades of experience and research have revealed that electronic components do have useful life limitations that significantly impact long-term reliability. Many modern components come with specific useful life data that are vital for designers making critical component selections. Recognizing this, some advanced FMEDA tools now incorporate Useful Life metrics. This webinar will show an example of how Useful Life metrics are determined and applied for a simple design using an FMEDA tool.
This paper describes an example new product development process designed to meet requirements of IEC 61508:2010 [1], the Basic Safety Standard for Functional Safety with a Systematic Capability Level 3 (SC 3). The example was done in the context of a microcomputer-based product which includes hardware and software done with…
IEC 61508 in the Safety Automation Equipment List
IEC 61508 in the Safety Automation Equipment List
Introduction: The European Union Cyber Resilience Act (CRA) is a landmark regulation designed to enhance cybersecurity across hardware and software with digital elements that are offered for sale within the EU. As cyber threats continue to evolve, the CRA introduces mandatory security requirements for manufacturers to ensure that products placed…
Medical devices are increasingly connected and increasingly targeted. This expert-led training equips professionals with the essential tools to identify cybersecurity threats, assess risks, and analyze vulnerabilities in line with global regulatory expectations. You’ll learn to think like an attacker to uncover weak points before they can be exploited - enhancing…
As medical devices become more connected, cybersecurity is critical for ensuring patient safety and regulatory compliance. This expert-led training provides an overview of medical device cybersecurity and equips R&D, QA, and regulatory teams with the tools to integrate cybersecurity into the full medical device development lifecycle.
To improve diagnostics in safety-critical applications, particularly those seeking IEC 61508 or ISO 26262 certification, product designers are replacing dedicated hardware monitoring components with microcontrollers. This paper describes the use of microcontrollers within safety product designs for power supply sequencing and fault detection, replacing multiple sequencers and voltage monitors, as…
When the latest edition of IEC61511 was published in 2016, one of the key changes was the emphasis on competency and some further guidance on what this means. The relevant clauses in the IEC61511:2016 are 5.2.2.1 to 5.2.2.3 under Clause 5.2.2: Organization and Resources. I am often asked what is…
IEC 61508 in the Safety Automation Equipment List
ISO 26262 in the Safety Automation Equipment List
ISO/SAE 21434 in the Security Automation Equipment List
exida is excited to release an updated version of the IEC 62443 End User templates . The new versions of the templates include revisions to ensure the latest standards compliance, as well as new templates to help with your cybersecurity management. Cybersecurity management for End Users is critical for maintaining…
IEC 61508 in the Safety Automation Equipment List
IEC 61508 in the Safety Automation Equipment List
IEC 62443-4-1, ISASecure SDLA in the Security Automation Equipment List
IEC 62443 in the Security Automation Equipment List
This paper describes a bad field failure data analysis practice where many field failures are ignored or discarded (filtered) before the failure rate calculation is done. This has been called “extreme data filtering.” Several examples are given. A failure rate resulting from this filtering process will be significantly lower than…
This paper details a method for determining the safety integrity level (SIL) of a Ball Valve/Emergency Release Coupling (BV/ERC) assembly. It examines how the design and arrangement of these components affect their reliability and the likelihood of dangerous failures. The study also shows how minimizing accidental “trips” of the system…
In exida’s Component Reliability Database (CRD) , every component includes a Useful Life expressed in years and/or cycles. Understanding Useful Life This post, drawing from exida's whitepaper [1] on how environmental factors impact component reliability, shows how Useful Life, like failure rates, is affected by factors such as temperature and…