Express Logic’s THREADX RTOS has been used in safety-critical products within the fields of avionics, medical devices, transportation, and industrial control equipment. Developers facing IEC, FDA, or other regulatory approval requirements for safety-critical operation now have 3 solutions from Express Logic to make their job easier:
- TUV Certification
- UL Certification
- Certification Pack
Each of these solutions offers benefits for developers of safety-critical systems:
TÜV Off-the-shelf Certification
THREADX has been certified by SGS-TÜV Saar for use in safety-critical systems, according to IEC-61508, IEC-62304, ISO 26262 and EN 50128. The certification confirms that THREADX can be used in the development of safety-related software for the highest safety integrity levels of IEC 61508, IEC 62304, ISO 26262 and EN 50128 for the
Functional Safety of electrical, electronic, and programmable electronic safety-related systems. SGS-TÜV Saar, formed through a joint venture of Germany’s SGS-Group and TÜV Saarland, has become the leading accredited, independent company for testing, auditing, verifying and certifying embedded software for safety-related systems worldwide. The industrial safety standard IEC 61508, and all standards that are derived from it, including IEC 62304, ISO 26262 and EN 50128, are used to ensure the functional safety of electrical, electronic, and programmable electronic safety-related medical devices, process control systems, industrial machinery, automobiles and railway control systems.
SGS-TÜV Saar has evaluated the relevant parts of Express Logic’s modified waterfall development process for THREADX, with phase overlap and phase blending, to ensure that best development practices have been followed at these stages:
- Requirements Management
SGS-TUV Saar, as part of the certification, has reviewed the extensive test suite for THREADX RTOS. The THREADX test suite, comprised of a large number of application simulations, effectively performs functional
black box testing over the entire THREADX RTOS. The tests exercise 100 percent of the generic THREADX C code, which is validated by using code coverage analysis tools. Express Logic’s THREADX Safety Manual documents these quality assurance measures, which enable developers to use THREADX in safety-critical software development for even the most rigorous Safety Integrity Level (SIL), according to IEC 61508, IEC 62304, ISO 26262 or EN 50128 without further qualification.
UL Off-the-shelf Certification
THREADX® has been recognized by UL for compliance with UL 60730-1 Annex H, CSA E60730-1 Annex H, IEC 60730-1 Annex H, UL 60335-1 Annex R, IEC 60335-1 Annex R, and UL 1998 safety standards for software in programmable components. UL is a global, independent, safety-science company with more than a century of expertise innovating safety solutions, ranging from the public adoption of electricity to breakthroughs in sustainability, renewable energy, and nanotechnology.
THREADX is the first RTOS to achieve UL recognition to the standards UL 60730-1, CSA E60730-1, IEC 60730-1, UL 60335-1, and IEC 60335-1, commented Jason R. Smith, Staff Engineer of UL.
We are excited that Express Logic now is able to apply the UL mark to its products, giving home appliance manufacturers confidence that they can use THREADX and be assured of its compliance with these important safety standards.
Along with IEC/UL 60730-1, which has requirements for “Controls Using Software” in its Annex H, the IEC 60335-1 standard describes the requirements for “Programmable Electronic Circuits” in its Annex R. IEC 60730 Annex H and IEC 60335-1 Annex R address the safety of MCU hardware and software used in appliances such as washing machines, dishwashers, dryers, refrigerators, freezers, and ovens. Building on the UL1998 foundation, additional requirements addressing the issues of software safety in programmable components for home appliances have now been added to the latest editions of the UL 60730/60335 standards. THREADX is the first to have satisfied those new requirements.
Custom Certification Pack Service for THREADX
The THREADX Certification Pack™ is a 100% complete, turnkey, industry-specific, stand-alone package that provides developers with ALL of the THREADX RTOS-related evidence needed to certify or successfully submit the THREADX based product to the highest reliability and criticality levels required for safety-critical aviation, medical, and industrial systems. With the THREADX Certification Pack, developers can concentrate on their application code, and not have to be concerned with documenting, testing, and validating THREADX itself. Instead, developers can simply submit the THREADX Certification Pack along with their own certification artifacts for their application, and satisfy all regulatory requirements.
The THREADX Certification Pack saves time, saves money, and reduces risk in achieving certification for safety-critical systems. THREADX has many design wins in the aviation, medical, and industrial controls markets, most of which have required, and achieved, regulatory approval or certification. Our success in these markets is due to the ease with which THREADX can be validated based on its well-commented, fully documented source code form, its proven track record of reliability and quality, the responsive support provided by Express Logic engineers, and our customer-friendly business and licensing model. THREADX has been shown to get developers to market much faster, and with higher reliability than alternative approaches. With the addition of the Certification Pack, Express Logic provides our customers with a market-proven, product-ready package that will save them time, save them money, and reduce their risk.
Standards Supported by THREADX Certification Packs
The following US and International standards are supported with THREADX Certification Packs
- Avionics — DO-178B, ED-12B, DO-278
- Medical — FDA510(k), IEC-62304, IEC-60601, ISO-14971
- Industrial — UL-1998, IEC-61508
- Transportation/Rail — CENELEC EN50128, BS50128, 49CFR236, IEC-61508
- Automotive — IEC-61508
- Nuclear — IEC-61508
Certification Pack Contents
Each Certification Pack contains the following information, subject to industry-specific variations dictated by the particular standard being addressed:
- Complete testing and documented results for all THREADX services
- Support for all major US and International safety-critical standards in aviation, medical, industrial
- Standards-specific process, design methodology & documentation
- configuration management
- quality assurance
- THREADX Code
Full source code and object code for THREADX on the customer’s target hardware
- source code of all tests
- test results
- code coverage and analysis
- unit/white-box, integration/black-box, acceptance testing
- plan for tool usage
Unit & integration test reports
- Requirements trace matrix
- Delivered 100% complete, stand-alone, ready to submit certification package or artifact package (medical) that demonstrates compliance
- running on the customer’s target hardware
- tested on the customer’s target hardware
- results and all reporting based on customer’s target hardware
- Safety Manual (where appropriate)
Certification Packs Save Time
Successful development teams possess a number of attributes: the ability to execute and meet schedules, the ability to deliver value, the ability to adapt to market demand. These attributes, combined with a clear understanding of what customers want and need, are the key to delivering profitable products. Express Logic can bring these decisive abilities to your development team.
Opportunity does not wait
In today’s fast-paced market, the ability to deliver a quality product before the competition frequently determines a product’s ultimate market share and profitability. In its “Embedded Market Survey” (2009) TechInsights reported that 57% of all software projects do not hit their targeted release date, the average being 4.4 months late. Since market windows do not move, or more accurately, do not move in a positive direction, there are few solutions to this problem. One is to allocate more resources to the project, another is to start the project sooner. Both these options can have a negative effect on other projects and research. A better option involves reducing the scope of a project. By using THREADX, a COTS RTOS, along with a COTS THREADX Certification Pack, developers can eliminate person-years or more from their project schedule.
Market Needs Change Overnight
While most safety critical markets move at a more stately pace than consumer electronics, they do experience change. Furthermore, much of this change is driven by commodity software infrastructure such as file systems, user interfaces, and connectivity. While these are commodities, they are complex and getting more complex every day. For much less than the cost of one dedicated software engineer’s annual salary, we will deliver a one hundred percent complete software certification package that meets the highest criticality and reliability requirements of the avionics, medical, industrial, nuclear, and transportation markets. We can help you meet your changing needs in weeks rather than years.
Certification Packs Reduce Cost
Each Certification Pack is typically delivered for less than ten percent the cost of a comparable in-house effort. While we invest heavily in our product line, our business model is based on selling our products many times. We price the product accordingly and amortize the development costs over many different deployments. Based on direct feedback from customers, we typically deliver turnkey, one hundred percent complete certification evidence for less than ten percent of the cost of a comparable in-house development effort.
Reliability is not cheap – but it can be affordable
While the figure varies from $75 to $300 per line of code, everyone who develops safety critical applications will tell you that complying with safety critical software specifications is not cheap. It can be affordable though.
Certification Packs, like commercial operating systems, are more cost-effective than in-house development due to the ability to amortize development costs over many customers, the ability to develop the depth and breadth of expertise needed to achieve quality products, and most importantly, the ability to focus on the exclusive value add your organization is known for.
Using our COTS certification products will accelerate your project, save money and, most importantly, save resources needed for developing other critical components of the project. Using a THREADX Certification Pack will cut more than eight developer-months off certification related activities, significantly reducing project cost.
Certification Packs Reduce Risk
THREADX Certification Packs mitigate risk in multiple ways: flexible licensing, fixed pricing, and field-proven experience.
Fixed upfront pricing prior to purchase
Managing risk and expenses is effortless when utilizing Certification Packs and Validation Kits. You will not see any unknown, inexact or post purchase order changes in the costs associated with your project. All Packs and Kits have fixed, upfront pricing.
Flexible licensing and business model
The considerable risk associated with bringing a safety critical product to market need not be increased with outrageous licensing restrictions. Express Logic’s licensing options are designed to facilitate the way you do business, not to constrain it.
THREADX has been used by successful companies in over billion deployed products. THREADX is the ultimate in field-proven reliability, and risk-free RTOS development. See our Customer Showcase for several examples from among our customers’ successful products in aerospace, medical, industrial, and consumer markets.
Certification Pack Benefits
- Zero customer effort is required to test and validate THREADX (saves time)
- Delivered in a fraction of time relative to an in-house effort. Eliminates approximately eight person-months of development and certification effort (saves time)
- Delivered at a fraction of the cost of an in-house effort (saves money)
- Delivered at a fraction of the cost of other commercial alternatives (saves money)
- Eliminates errors from in-house effort (reduces risk)
Certification Pack Specifications
The Express Logic Certification Pack™ for THREADX is delivered 100% complete, running and tested on your target hardware, and provides a complete set of tests and documentation to prove the suitability of the THREADX software for use in end products. The Certification Packs are compatible with virtually any processor and toolset that includes an ANSI compatible C compiler. Available for THREADX version 5.3 onward, the suite provides complete coverage for all THREADX APIs and services.
For system certification submission, developers simply include and reference the Certification Pack material in their final device documentation package.
The Aviation Certification Pack™ for THREADX is a complete FAA/JAA/CAA/EASA/EUROCAE certifiable package of standards, designs, source code, test code and all related documentation for Express Logic’s THREADX real-time operating system (RTOS). The Certification Pack includes a complete set of standards, designs, test code, trace matrices and all related documentation for certification up through DO-178B Level A / ED-12b, Level A / DO-278 AL1.
The Medical Certification Pack™ for THREADX is a complete package of standards, designs, source code, and all related documentation for Express Logic’s THREADX real-time operating system (RTOS) for use in meeting the requirements of FDA 510(k) / PMA / IEC-61508 / IEC-62304 / ISO-14971. The Medical Certification Pack of software and documentation is available for all levels of approval and certification, including FDA Class III and IEC-62304 Level C medical devices.
The Industrial Certification Pack™ for THREADX is a complete IEC certifiable package of standards, designs, source code, test code and all related documentation for Express Logic’s THREADX RTOS, for certification to IEC-61508.
The Transportation Certification Pack™ for THREADX contains everything needed to certify Express Logic’s THREADX Real Time Operating System in devices certified to EN-50128, BS-50128, IEC-61508 and 49CFR236 Subpart H. The Transportation Certification Pack™ is suitable for use at all levels of certification, including the highest criticality – SIL4 (IEC-61508) and SIL 5 (EN50128, BS) systems.
THREADX Certification Pack™ Contents Summary
|SRS-AA00.pdf||Software Safety Requirements Specification|
|SCMP-AA00.pdf||Software Configuration Management Plan|
|SDP-AA00.pdf||Software Development Plan|
|SQAP-AA00.pdf||Software Quality Assurance Plan|
|SVP-AA00.pdf||Software Verification Plan|
|SWRD-AA00.pdf||Core Software Requirements Document|
|SDD-AA00.pdf||Core Software Design Document|
|SITP-AA00.pdf||Core Integration Test Plans and Code|
|SUTP-AA00-xx.pdf||Core Unit Test Plans and Code|
|VSTD-ACODE.pdf||Assembly Language Coding Standard|
|VSTD-CCODE.pdf||C Language Coding Standard|
|VSTD-SWDS.pdf||Software Design Standard|
|VSTD-SWRS.pdf||Software Requirements Standard|
|VSTD-CRPR.pdf||Code Review Procedure|
|VSTD-DRPR.pdf||Document Review Procedure|
|DRS-AA00-XX||Document Review Sheets|
|CRS-AA00-XX.x||Code Review Sheets|
|ReqPro Folder||Requisite Pro Database and Reports|
|PSAC- XXXX||Plan for Software Aspects of Certification|
|SSVP-XXXX||Software Safety Validation Plan|
|PSRD-XXXX||Port Software Requirements Document|
|PSDD-XXXX||Port Software Design Document|
|SITP-XXXX||Port Integration Test Plans and Code|
|SITProc-XXXX||Target Integration Test Procedures|
|SITR-XXXX||Target Integration Test Report|
|SUTP-XXXX||Port Software Unit Test Plan CA/CC|
|SUTProc-XXXX||Target Unit Test Procedures|
|SUTR-XXXX||Target Unit Test Reports|
|SWUG-XXXX||Software Users Guide|
|SCM-XXXX||Software Correlation Matrix / Test Coverage Report|
|SCI-XXXX||Software Life Cycle Environment Configuration Index/Software Configuration Index|
|SAS-XXXX||Software Accomplishment Summary|
|DRS-XXXX-XX||Document Review Sheets|
|CRS-XXXX-XX.x||Code Review Sheets|
|VSQA-YYYY||Process Review Checklists and Audit Reports|
|ReqPro Folder||Requisite Pro Database and Reports|
|Results Folder||Intermediate Lint and Test Results|
|Lint Folder||Lint Static Analysis Configuration Files|
|CTQP-XXXX||Compiler Tool Qualification Plan|
|VSTD-CTQP||Cantata Tool Qualification Plan|