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.
- 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