Product Certificate: Functional Safety (IEC 61508)

SAFETY INTEGRITY LEVEL (SIL)

Hardware and software safety systems in the industrial sector are becoming increasingly complex. Components are now sourced from multiple markets. In addition, development lifecycles have been significantly compressed. To mitigate these factors, your company must have a strategy for dealing with safety risks.

WHAT IS FUNCTIONAL SAFETY?

Functional safety is the aspect of a system’s overall safety that depends on the system or equipment operating correctly in response to its inputs. This includes the safe management of potential operator errors, environmental changes, and hardware and software failures. Functional safety is an additional step beyond the traditional product safety assessment, as it deals with complex and interconnected technologies.

WHY IS FUNCTIONAL SAFETY IMPORTANT?

Companies operating in industrial environments are responsible for reducing safety risks to an acceptable level, including hazards caused by malfunctions of complex systems. Functional safety failures can result in serious liability claims. IEC 61508 is the standard governing functional safety worldwide as well as the derived standards: EN ISO 13849-1, IEC 62061, ISO 26262 and the EN 5012X series.

WHY CHOOSE WECERT FOR FUNCTIONAL SAFETY?

WECERT offers extensive sector specific experience in functional safety issues. Our extensive suite of in-house services includes independent safety assessment, certification and knowledge services. We can serve as a testing and certification partner to help your company achieve compliance at an acceptable cost.

Type approvals of safety-related products

Type approvals provide evidence that a product meets the requirements of relevant product standards and that it can be used in the specified range of operation.

A type approval is structured in the following phases:

Concept inspection: Because of the complexity of today’s devices, tests are carried out parallel to product development. The testing authority cooperates with the manufacturer during the early product specification and conception phases.
Main inspection: During this phase, additional FS product tests are carried out. These include the calculation or validation of mandatory quantitative numbers according to IEC 61508, for a Safety Integrity Level (SIL); climatic, mechanical and electric testing for environmental aptitude; electric safety and equipment testing; assessment of applied measures for failure avoidance (quality assurance) covering the total life cycle of a product; inspection and evaluation of product documentation, especially installation and operating instructions and safety manuals. The main inspection concludes with a final test report.
Certification: It is possible to certify both products and processes managing the product life-cycle. Any functional safety requirement for a component, subsystem or system should be independently certified according to one of the recognized functional safety standards. A certified product is then considered functionally safe to a particular SIL or a performance level in a specific range of applications. The certificate is provided to the customer with a test report describing the scope and limits of performance. All valid FS certificates issued by us for safety-related products and systems are available at Certipedia, our certificate database.

Functional safety certification means compliance

Our functional safety product assessments help you ensure that requirements and standards have been fulfilled. They also save time and money, enabling manufacturers to streamline development efforts, since our support starts in the early phases of concept development. This way our team of experts identifies possible obstacles early in the development process. This reduces the risk of unplanned additional development cycles. We document the fulfillment of relevant safety standards through the certification process and with our test mark, which reduces your liability and increases trust in your company.

Reliable functional safety assessments for your products

Identifying
the required safety functions and risk reduction. A process of reviews and discussion of the intended function as well as formal hazard and risk analysis are applied to distinguish hazards and corresponding safety functions.
Assessment
of the safety function using a Safety Integrity Level (SIL) inspection of the development documentation of the product. SlL refers to the end-to-end safety function of the overall safety-related system, not only to a component or part of the system.
Ensuring
safety functions perform according to the identified requirements and their design intent while considering potential incorrect operator input and failure modes. This requires having both the design and lifecycle managed by qualified and competent engineers carrying out processes to a recognized functional safety standard. Today, the “mother” standard, IEC / EN 61508, or one of its industry-specific standards are the recognized standards for functional safety.
Verification
that the system meets the assigned SIL, by determining the relevant safety-related parameters, i.e., the hardware fault tolerance (HFT), the average probability of dangerous failure on demand (PFDavg), the average frequency of dangerous failure (PFH), and the safe failure fraction (SFF) of safety-related elements, along with appropriate tests. The safe failure fraction is the percentage of failures in an element resulting the system to failing a safe. Dangerous or critical states are identified by a failure mode effects analysis (FMEA) or a failure mode criticality analysis (FMECA).

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Functional Safety

We help improve the safety of products and the systems containing those products by navigating the complex technical challenges of today’s functional safety landscape.

Mechanical products suitable for functional safety certification include:

Equipment parts with safety functions.
Industrial valves and sub-systems.
Hydraulic, pneumatic and electromechanical components.
Hydraulic, pneumatic and electrical drives and actuators.
Hydraulic and pneumatic control systems.
Sensors for physical size measurements like temperature, pressure, fill level and flow rate.

After confirming that your mechanical components are in accordance with ISO 61508, we apply our “SIL/PL capability” test mark.

Benefits

Building on our safety science and engineering expertise in many different functional safety domains — including automation and machinery, signaling and alarm systems, medical devices, automotive, autonomous vehicles, lighting and appliances — we provide customers with a single global partner for all safety challenges and specific market needs.

Manufacturers, system integrators and suppliers around the world are able to take advantage of the full depth of our services, bundling traditional WECERT product safety investigations with our functional safety assessments for greater project efficiencies and speed to market.

Whatever the need or challenge, we can help determine the best assessment process for specific products, based on the reasons for conducting a functional safety assessment and/or a product’s intended use.

Some European directives require a functional safety evaluation of specific products. Trade unions and regulatory bodies such as the U.S. OSHA require or encourage a functional safety evaluation in addition to a traditional safety evaluation. Insurers also may require a functional safety evaluation before a customer installs equipment in a workplace and may provide discounted premiums to customers who use products that have been evaluated for functional safety. We are expertly qualified to help customers address these unique requirements and can help reinforce a point of differentiation in the marketplace through the use of the UL Mark, one of the most recognized symbols in the world.