IEC 60601-1-12 was released in 2014. It covers the basic safety and essential performance requirements for medical electrical equipment and medical electrical systems intended for use by emergency medical services.
Since 2014, it has been adopted for the IECEE CB Scheme, an international system for mutual acceptance of test reports and certificates dealing with safety in electrical and electronic components, equipment and products, and the US Food and Drug Administration’s (FDA) “List of Recognized Consensus Standards”. It is also expected that the European Commission will soon implement IEC 60601-1-12, probably during the transition to the new Medical Devices Directive (MDR) in 2020.
In some respects, IEC 60601-1-12 is similar to existing European standards. For example, some of its requirements match those in EN 1789 for medical vehicles and their equipment, and EN 13718-1 for medical devices used in air ambulances. IEC 60601-1-12 differs from existing standards because it melds the requirements from different applications (road ambulance, helicopter, airborne) into one standard. It should therefore be treated as the decisive standard for active medical equipment used in and around ambulances and at locations where emergency medical services are needed, e.g. accident or crash sites. Because of this, the standard is applicable to a wide range of medical devices.
The key constructional requirements of IEC 60601-1-12 are:
- It addresses special requirements for equipment power supply provisions, depending on where the devices are intended to be used:
- Equipment shall be classified protection Class II, which means the degree of protection against electric shall not be relied upon protective earth, or internally powered by means of battery
- The power supply unit of the medical equipment must be able to withstand an AC Mains voltage supply tolerance from 85% to 110% of nominal voltage range.
- For equipment intended to be supplied by DC voltage (e.g. by car battery) the equipment shall maintain its function under following circumstances:
- 30 s dip from 12V to 10V for 12Vdc rating and fluctuations between 12.4 V to 15.1 V
- 30 s dip from 24V to 20V for 24Vdc rating and fluctuations between 24.8 V to 30.3 V
- If the medical equipment is intended to be operated in aircrafts, devices must be capable working with following supplies:
- 14, 28, and 270 Vdc; and
- 115/230 V at 400 Hz
- Devices used by emergency services, where environmental conditions can be unpredictable, must be able to operate for:
- A minimum of 20 minutes at a temperature range of -20 to + 50 °C, in an atmospheric pressure range of 620 hPa to 1060 hPa and with relative humidity of between 15 and 90%
Indications on the equipment for setting up the device, controlling the equipment or analyzing results should be designed so that they are readily accessible between an illuminance level from 10 to 10,000 lx – twilight to full daylight.
Depending on different parameters of equipment usage, if the equipment is intended for use in helicopters or aircraft, the mechanical stability of the devices must be rugged enough to withstand shock, vibration or free fall tests.
Equipment must also be designed to stop the ingress of water and particulates:
- Fixed or permanently installed equipment types – not intended to be moved by medical and paramedical staff – must withstand an ingress stand of IP22, defined under IEC 60529
- Transportable equipment types must at least resist to IP33 test without loss of functionality
Resistance against ingress of water and particulates will also directly affect the constructional requirements for preventing electric shocks to the operator and/or the patient.
Manufacturers of emergency medical equipment must also consider risk from electromagnetic disturbances. Medical equipment used in the EMS environment must not emit excessive electromagnetic radiation in order to avoid breakdown or malfunctioning of other devices used in the proximity of the emergency application. Equipment must comply with the maximum emission levels for Class B products, addressed in CISPR 11:2009, unless it is to be carried in aircrafts, when RTCA DO-160G, Section 21, Category M for electromagnetic emission testing must be applied in addition to IEC 60601-1-2.
SGS offers cost-effective testing and certification services that help manufacturers efficiently bring their emergency medical equipment products to the marketplace. We are accredited by DAkkS (ILAC) and IECEE CB Scheme to test active medical devices to IEC 60601-1-12, EN 1789 and EN 13718-1 standards.
Our experts can assist with IEC 60601-1-12 testing and certification for the complete spectrum of products. They offer a one-stop-shop service for all testing requirements – constructional, environmental, mechanical, and electromagnetic compatibility. They work with customers to create a tailor-made program covering all relevant parameters and sequences.
For more information, please contact:
Business Development Manager Medical Products
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