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Functional Safety in the Medical Industry

Keeping you safe

The IEC 60601-1:2005 3rd Edition was published in 2005, and will replace the 2nd 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.

Area Services


  • Electrical Safety Testing
  • EMC Testing
  • Environmental Testing

Independent Safety Assessment (ISA)

  • Conformity assessment against the relevant Medical Devices, Active Implantable Medical Devices or In Vitro Diagnostic Medical Devices Directives
  • Assessment of safety-related issues
  • Assessment of the functional safety of active medical devices (safety of hardware and software
  • Assessment of the usability of active medical devices
  • Assessment of Risk Management files


TÜV SÜD will certify your product to all relevant safety standards. Your choice to work with a leading, premium third party that issues the globally recognised TÜV SÜD Mark, will demonstrate to your stakeholders your commitment to safety and reliability.


  • Functional safety – Basic Training
  • Functional Safety – Expert Training
  • Risk management and Risk analysis for medical devices according to ISO 14971
  • CE-certification of medical software
  • Implementation of the standard IEC 62304 for manufacturer's of medical devices

Your benefits at a glance

  • TÜV SÜD is the world’s largest Medical Device Notified Body
  • We can provide guidance to manufacturers to help them through the complexities of the third edition of the Medical Electrical Equipment Standard
  • TÜV SÜD and its subsidiaries cover the whole range from planning to the final safety assessment
  • TÜV SÜD has global in-depth knowledge of processes and procedures in the medical sector
  • TÜV SÜD has a base of international and local experts in all key markets worldwide
  • Our experts work with your along the entire product development lifecycle and support you from the onset of your project with technical expertise that will result in a safe and reliable product
  • Our unique pro-active and pragmatic approach ensures you achieve compliance at acceptable cost
  • TÜV SÜD is one of the leading global independent assessment bodies with a sterling track record