Standards, Regulations, Technologies

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.

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.

The ISO 26262 series of standards was published in 2011 to minimize the risk of potentially dangerous malfunctions of electrical and electronic vehicle components. ISO 26262 is based on IEC 61508, the basic standard for functional safety (FuSi for short) of electrical and electronic systems. It provides an established procedural model for the development and production of series vehicles, taking particular account of the requirements in the automotive sector.

UNECE R 155 and R 156 are regulations on cybersecurity and software updates for vehicles issued by the United Nations Economic Commission for Europe (UNECE). They are aimed at vehicle manufacturers and oblige them to introduce cybersecurity (CSMS) and software update management systems (SUMS) to ensure the safety and integrity of connected vehicles. These regulations, which will apply to all newly produced vehicles from July 2024, cover a wide range of vehicle types, including passenger and goods transportation vehicles and agricultural machinery, and include comprehensive requirements for risk management, security updates and documentation.

The IEC 62443 series of standards is aimed at manufacturers, operators and integrators and deals with the IT security of industrial automation and control systems (IACS) in order to ensure the availability, integrity and confidentiality of these systems. It takes into account the entire life cycle of products and systems, including the segmentation of networks into security zones and the assignment of security levels. Each role (manufacturer, integrator, operator) has specific security requirements in order to continuously improve protection against threats.