The term “Functional Safety” is commonly used in most industries. However, the medical device industry does not make explicit use of it, instead using the term “Essential Performance” to summarize all aspects related to the reliable and safe function of medical devices and equipment. We explain the requirements covered by this term and how medical device manufacturers can make sure of fulfilling them.
The aspects covered by Functional Safety
The requirements for the reliability and safety of active medical devices are derived from the Medical Device Directive (MDD) and defined in the standards on electrical safety (EN 60601 and IEC 60601-1 respectively) and/or the pertinent particular standards covering the requirements for individual product groups. According to the MDD and the IEC 60601-1 standard, protective measures must be implemented to ensure the safety of patients and users if a device does not offer inherent safety by design.
Medical devices must fulfill single-fault safety requirements, i.e., even in the event of a fault they must not pose unacceptable risks for users and patients. Medical equipment which may cause significant injuries or even death in case of malfunction must be provided with systems that gives protection under single-fault conditions.
Some of these systems are specified in equipment-specific electrical safety standards (Essential Performance, IEC 60601-2-xx). When reviewing risk assessment within the course of the review of the Technical Documentation, TÜV SÜD also verifies compliance with these requirements as a special aspect under the headline of “Functional Safety”.
How to ensure Functional Safety
Manufacturers of medical equipment must compile and assess the risks associated with the use of their equipment. Safety under single-fault conditions and the necessary protection systems must be incorporated at the design stage. The principles of Functional Safety offer excellent guidance. Manufacturers wishing to avoid the risk of costly and laborious design changes can have their safety concepts and architectures tested for conformity with the relevant standards by the Functional Safety experts of TÜV SÜD Product Service as early as the product design and development phase.