Glossary Term
Functional Safety
Definition
Functional safety is the aspect of safety that ensures a system or device operates correctly under both normal and fault conditions. It involves the implementation of safety functions designed to prevent harm or damage due to malfunction or failure of a system, particularly in critical industries such as MedTech. In medical devices, functional safety ensures that the device performs safely and as intended during operation, even in the event of hardware or software failures.
Relevance to the MedTech Industry
In MedTech, functional safety is crucial for patient safety. Medical devices must be designed and tested to meet safety standards that prevent failures that could lead to harm. Ensuring functional safety involves applying specific standards (e.g., IEC 61508, ISO 14971) and implementing fail-safe mechanisms, redundancy, and risk mitigation strategies during the design, testing, and operational phases of the device lifecycle.
Additional Information & Related Terms
Related Terms
Risk Management (ISO 14971): Functional safety is closely related to risk management, as both focus on identifying and mitigating potential risks to patient safety in medical devices.
IEC 61508: An international standard for functional safety in electrical, electronic, and programmable electronic systems, which is often applied in medical device safety standards.
Safety Integrity Level (SIL): A measure used to determine the required safety level for a device or system based on its functional safety performance and risk assessment.
Fail-Safe Design: A design approach where critical functions are designed to continue or safely fail in the event of a malfunction, ensuring that the system doesn’t lead to catastrophic failure.
Validation and Verification: Processes used to confirm that a medical device meets functional safety requirements, ensuring it works as intended in normal and fault conditions.