IEC 62304 Certification for Medical Devices
Sophisticated medical devices have high cost saving potential. They are more and more used for the provision of patient care. Software is often an integral part of medical devices technology. The appliances directly in use at the patient have proven to be safe. The software has to be certified according to IEC 62304, the standard for functional safety of medical devices.
Medical Device Certification according to IEC 62304
Functional safety of software for medical devices is certified according to IEC 62304, a standard for the software life cycle processes of medical device software, released in 2006. IEC 62304 requires safety classification of software and defines processes for SW development, maintenance and risk management, configuration management, problem-solving processes, and quality management. IEC 62304 classifies three safety classes where Class A appoints the lowest (no risk) and Class C the highest class (risk of death or severe injuries). As certification requirements of safety-critical software are similar across different markets, a real-time operating system certified after DO-178B for use in safety-critical avionics is an ideal software platform for medical devices, too.
Micro-Kernel based PikeOS Embedded Virtualization
PikeOS has been designed for use in safety-critical applications and has gone through a comprehensive validation according to safety standards like DO-178B, EN 50128, IEC 62304, IEC 61508, ISO 26262, IEC 61513 of either the avionics, automotive, railway, medical, industrial automation or nuclear power plants. Since only the micro-kernel runs in privileged mode, all of its code contributes to the trusted code base of every application that might run on top of it. The effort of certifying a program is roughly proportional to the amount of code to be examined. This comprises the code of the program itself, but also that of the run-time environment (i.e. operating system, libraries etc.) which the program relies on.
Therefore, the PikeOS micro-kernel consists of less than 10.000 lines of code making certification less expensive than that of conventional monolithic real-time operating systems. Even better: PikeOS allows the combination of application of different levels of criticality on a single hardware platform where every application can be certified independently from others.
SYSGO Research Projects on Safety for Medical Devices
SYSGO is partner of important research projects on safety for medical devices
- INTERESTED: Seamless Tool-Chain for safety-critical Applications
- JEOPARD: Real-time Java on Multi-Core CPUs
- TECOM: Trusted Embedded Computing
- PROARTIS: Probabilistically Analysable Real-Time Systems