Certification Services (including Product Certification)
ESC has extensive experience in providing product certification based on the requirements of IEC 61508 (up to and including SIL 3). ESC can determine a device / product / systems’ hardware and systematic SIL capability by means of a qualitative and quantitative assessment, inclusive of:
- Functional Safety Management (FSM) review or audit
- Random Hardware Reliability using Failure Mode and Effects Analysis (FMEA) technique and applying it to the appropriate requirements of the safety application and system/product under study (e.g. FMEDA/FMECA)
- Assessment of design, techniques and procedures against systematic failure requirements and / or proven is use assessment to IEC 61608 / prior use assessment to IEC 61511
The assessment is made with the specific safety application in mind, and where successful, a certificate stating the SIL capability of the device / product / system intended to be used in the safety application can be issued, in line with the expectations of IEC 61508.
Compliance with IEC 61508
To demonstrate compliance with IEC 61508 for a device / product / system that is intended for use within a SIL rated safety function, it is necessary to consider the followings aspects of the design processes of the device / product:
- Random Hardware Requirements
- Architectural Constraints
- Systematic Capability Requirements
Full compliance with the requirements of IEC 61508 for product certification can only be claimed when all aspects are considered (hardware, architectural and systematic capability). Where the focus is on the reliability of the product or system then, random hardware requirements’ and ‘architectural constraints’ should be considered, as a minimum.
Our approach to Device Certification/Product Certification/System Certification
Many sources of IEC 61508 certification can be:
- Obscure and undefined data supporting the evidence to back the claims
- Overly focused on single aspects of IEC 61508 (e.g. PFD targets), rather than pro-actively selective and pragmatic in the interpretation of the requirements for the specific safety application
- Use of generic data without calibration or not aligned with the intended safety application, failing to consider the levels of uncertainty associated with the available data
- Unrealistically time consuming and expensive
As part of our product certification services, ESC’s approach to device certification / product certification / system certification for safety applications offers:
- Full visibility and traceability of the analysis conducted, including the choice of component failure rate and failure mode data
- Calibration of the FMEA with field data, prior use and warranty based data (where possible for end users with recorded failure data)
- Access to expert studies addressing the optimism of warranty based data arising from a number of factors (e.g. mismatch of time scales, failed items not rectified etc.)
- Full access to the extensive Technis FARADIP database
- A realistic assessment of the life cycle activities and documentation at an appropriate rigor, having regard to the simplicity / complexity of the product / device
- A realistic time scale aligned with the complexity of the application
- A pragmatic application of the IEC 61508 requirements
- A realistic cost
Product Certificate Database
A list of our issued certificates can be found here in our Product Certificate Database with a copy of the certificate to download.
Our Functional Safety FAQs are a great place to start if you have any questions.
If you’d like any further information or would like to talk to one of our consultants please Contact Us via our contact form and we’ll be glad to help.