Our two previous articles have already dealt with the basic standard 60601-1 and the supplementary standard 60601-1-11 for active medical devices in the home environment. With this article, we would like to address another essential area from the IEC 60601 family of standards: IEC 60601-1-12 for requirements for medical electrical equipment and systems in the emergency response environment.
The IEC 60601-1-12:2016
This supplementary standard is applied to the basic safety and performance characteristics of medical electrical equipment (ME equipment) and its systems intended for use in the emergency use environment in accordance with the manufacturer’s instructions for use.
The emergency use environment is defined in Section 3.1 of the standard and describes actual conditions and environments in which operators use the ME device or ME system. These include:
Emergencies and their environments outside of a professional healthcare facility.
Environments in which a patient may receive medical care and basic or advanced life support
Conditions and environments during professional ambulance transport to a healthcare facility or between healthcare facilities.
Thus, this standard provides general requirements for equipment brought to the emergency scene and used both there and during transport where environmental conditions differ from those indoors.
Requirements for ME equipment for emergency use
The requirements described in IEC 60601-1-12 are critical to the safety and performance of ME equipment for emergency use. In addition to the requirements of the general standard, portable equipment must be Protection Class II or internally powered, must not have a functional earth connection, and only Type BF and CF applied parts are permitted. In addition, other requirements must be observed: Additional requirements for legibility of labeling, additional requirements for instructions for use, additional requirements for electrical power supply and in case of interruption of power supply, and additional requirements regarding ingress of water or dust into ME equipment and ME systems:
Additional features
ME equipment must also be protected against electrical hazards from the equipment itself. Therefore, for non-fixed and non-permanently installed equipment, an authoritative insulation protection cover must be fitted.
Accuracy of controls and displays, as well as protection from hazardous output levels, must still be given additional consideration in the design process, usability, and risk management process.
For fixed or permanently installed ME equipment of protection class I, a technical description must be available that also contains all relevant warnings.
Don’t lose sight of the big picture
The requirements of the supplementary standard for ME devices in emergency medicine are very extensive. However, it is extremely important to implement all the necessary features, because these are medical devices that can make the difference between life and death for patients in an emergency. Thus, it is essential to follow a clear structure when implementing the specific requirements to ensure with definite certainty the safety of the ME devices.
If you and your company need assistance with implementation, please do not hesitate to contact us.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
