Helping medical manufacturers understand IEC 60601-1-12

Released in 2014, IEC 60601-1-12 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. It has also been included on the US Food and Drug Administration’s (FDA) ‘List of Recognised Consensus Standards’ and is also expected to be implemented by the European Commission, probably when it transitions to the new Medical Devices Directive (MDR) in 2020.

IEC 60601-1-12 is similar, in some respects, to current European standards. It matches the requirements in EN 1789 for medical vehicles and their equipment and EN 13718-1 for medical devices used in air ambulances.

It differs, however, in that it amalgamates the requirements from different applications (road ambulance, helicopter, airborne) into a single standard. Manufacturers of a wide variety of medical devices can therefore look on IEC 60601-1-12 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.

The key constructional requirements of IEC 60601-1-12 relating to power provision are:

• Equipment is classified as Class II, meaning protection must not rely upon an earth or the equipment should use an internal battery power supply.
• Must be able to withstand an AC Mains voltage supply tolerance from 85% to 110% of nominal voltage range.
• Equipment intended to be supplied by DC voltage (e.g. by car battery) must maintain its function under the following circumstances:
  
  • A 30 s dip from 12 to 10V for 12Vdc rating and fluctuations between 12.4 and 15.1V.
  • A 30 s dip from 24 to 20V for 24Vdc rating and fluctuations between 24.8 and 30.3V.
• Medical equipment intended for operation in aircraft must be capable working with following supplies:
  
  • 14, 28, and 270 Vdc.
  • 115/230 V at 400 Hz.
• Must operate for a minimum of 20 minutes in the following environmental conditions:
  • Temperature range of -20 to +50°C.
  • Atmospheric pressure range of 620 hPa to 1060 hPa.
  • Relative humidity of between 15 and 90%.

The standard also requires that the instructions for setting up and controlling the unit, and analysing the results, must be readily accessible and visible between an illuminance level from ten to 10,000 lx – twilight to full daylight.

The standard also covers the mechanical stability a piece of equipment must observe to perform its task. For example, equipment used in helicopters or aircraft must be rugged enough to withstand shock, vibration and/or free fall tests. It should also be designed in a way that will resist the ingress of water and particulates without loss of functionality. The applicable tests are:

• Fixed or permanently installed equipment types – IP22 test, defined under IEC 60529.
• Transportable equipment types – IP33 test.

Stakeholders should be aware that ingress resistance will also directly affect the constructional requirements for preventing electric shocks to the operator and/or the patient.

Emergency medical equipment manufacturers should also consider the risk of electromagnetic disturbances. Their equipment 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.

With IEC 60601-1-12 gaining acceptance with authorities around the world, SGS is advising manufacturers of emergency medical equipment to now check their products comply with its requirements.

SGS offers a cost-effective testing and certification service to help these manufacturers efficiently bring their emergency medical equipment products to the marketplace. Accredited by DAkkS (ILAC) and the IECEE CB Scheme to test the full spectrum of medical devices to IEC 60601-1-12, as well as the EN 1789 and EN 13718-1 standards, offering a one-stop-shop approach to compliance.