Here you will find background information on safety and security-related standards, regulations and technologies. We are continuously expanding this knowledge area - so it's worth visiting the site from time to time.
IEC 61508 is an internationally accepted standard for functional safety. It describes the requirements for the development of safety-critical systems and provides guidelines for the assessment and management of the safety of such systems. The standard is not dependent on technology and applies to all types of safety-critical systems, regardless of their area of application or industry sector. IEC 61508 is often used as a reference standard for other safety standards, including industry-specific standards such as ISO 26262 for the automotive industry.
The international IEC 60601 series of standards contains requirements for the safety and ergonomics of medical electrical devices. It is identical to the European standard EN 60601 (in Germany: DIN EN 60601) and deals with aspects of electrical, mechanical, electromechanical, thermal and functional safety of ME devices.
The IEC 81001-5-1 standard "Health software and health IT systems Safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle". It represents the standard for the cyber-secure development of healthcare software and its protection against unauthorized tampering throughout its lifecycle. We explain who is affected by the standard, what exactly it regulates and how it relates to other regulations.
