Functional Safety in the Medical Industry

Keeping you safe

The IEC 60601-1:2005 3rd Edition was published in 2005, and will replace the 2^nd edition which expires on June 1, 2012. This harmonised standard for medical electrical equipment is recognised by public health authorities in most countries.

The 3rd edition includes new requirements concerning functional safety, referred to in the standard as “essential performance”. The manufacturer must demonstrate that the risk control measures they have deployed into their medical electrical equipment or system not only maintains basic safety but that it remains functionally safe. The consequences of not meeting functional safety requirements can be disastrous not just for the manufacturer  but to a patient, operator, or a third party. Apart from the 3rd Edition there are many particular standards (e.g. dialysis, infusion pumps, critical care ventilators) which have clear requirements targeting functional safety.

As an independent organisation with longstanding experience in the medical sector and regulatory compliance, TÜV SÜD can support with a comprehensive range of functional safety assessment, testing, certification and training services. Our functional safety services complement a complete portfolio of services for the Healthcare industry.