IEC 61508 (Functional safety of electrical/electronic/programmable electronic safety-related systems) is an international, industry-independent functional safety standard. The seven-part standard spans IEC 61508-1 to IEC 61508-7. IEC 61508-3 is concerned with software development, verification, and validation. IEC 61508-3 highly recommends certified tools and translators for safety integrity levels (SILs) SIL 2 and higher; clause 7.4.4 provides “Requirements for support tools.
ISO 26262 (Road vehicles — Functional safety) is an international functional safety standard. It is an adaptation of IEC 61508 specific to the application sector of electrical and electronic systems in the road vehicle industry. It consists of 10 parts: ISO 26262-1 to ISO 26262-10. ISO 26262-6 pertains to software development, verification, and validation. It includes guidance for projects using Model-Based Design and code generation. ISO 26262-8 addresses multiple cross-functional topics, including the classification and qualification of software tools. The degree of rigor required for tool qualification is based on the tool classification level (TCL) and the software automotive safety integrity levels (ASILs) A to D.
EN 50128 (Railway applications — Software for railway control and protection systems) is a European standard that specifies procedures and technical requirements for the development of programmable electronic systems for use in railway control and protection applications. EN 50128, developed by the European Committee for Electrotechnical Standardization (CENELEC), is part of a series of standards that represent the railway application-specific interpretation of the IEC 61508 standard series.
IEC 62304 (Medical device software – Software life cycle processes) is an international standard that describes the software development and maintenance processes required for medical device software. The required processes, tasks, and activities are impacted by the hazard (risk to patient, caregiver, or environment) level of the device software. The hazard levels are divided into 3 safety classes: Class A - No injury or damage to health is possible, Class B - Non-serious injury is possible, and Class C - Death or serious injury is possible. IEC 62304 does not directly address software tool qualification. However, it states that IEC 61508 can be looked to as a source of methods, tools and techniques that can be used to implement the requirements in IEC 62304. Additional guidance on tool validation for regional authorities such as the FDA is available on the FDA software validation page.
IEC Certification Kit includes TÜV SÜD certificates for IEC 61508:2010, ISO 26262:2011, EN 50128:2011, IEC 62304:2006, and IEC 61511:2003. You can also use IEC Certification Kit as a basis for qualifying tools and for guidance on using Model-Based Design to develop systems requiring certification to other IEC 61508–related standards and adaptions.
IEC Certification Kit follows an in-context approach to tool certification or qualification based on a typical workflow or use cases when the applicant applies supported tools to develop or verify software for functional safety standard-compliant or standard-certified applications. The workflow addresses risk levels ASIL A–ASIL D according to ISO 26262, SIL 1–SIL 3 according to IEC 61508, and SIL 0–SIL 4 according to EN 50128. The applicant must use the tools within the referenced workflows and within the constraints and use cases specified in the certification plans of the applicant’s projects.
IEC Certification Kit is designed to help you provide a complete certification package to certification authorities using MATLAB®, Simulink, and Polyspace products. To use IEC Certification Kit, follow these steps:
IEC Certification Kit provides guidance and information for the above steps and includes the document templates, test cases, and test procedures that you need to qualify the supported Simulink and Polyspace products.
For supported products, IEC Certification Kit includes these artifacts:
You need to execute the test cases and procedures from IEC Qualification Kit in your MATLAB or Polyspace installation environment. You should then compare your generated test results with the expected results from the kit and work to eliminate any differences.
IEC Certification Kit provides detailed workflow guidance needed for developing and verifying systems using Model-Based Design. The workflow guidance describes processes, methods, and tools used for each software development and verification step from high-level requirements validation to executable object code verification.
With IEC Certification Kit, you can generate a traceability matrix spreadsheet showing requirements-to-model-to-code bidirectional traceability paths and file information. You can also use IEC Certification Kit to generate a list of reported bugs that you can store and archive for key Simulink and Polyspace tools used for Model-Based Design.
Note: Simulink and Polyspace were not developed using an IEC 61508–compliant process. Using certified tools does not ensure the safety of the software or the system under consideration.